260 Clinical Development Jobs - Page 5

About the job The remit of the Patient Insights, Outcomes and Innovations team at Sanofi is to incorporate the patients perspective (and other subjective perspectives, including clinicians and caregivers) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods. The PCIOI team reports into the Office of Patient Informed Development and Health Value Translation (PID&HVT). Within this function the team supports all business units in deriving a patient-centric understanding of conditions and measuring relevant concepts of the condition and its treatment in a scientifically robust manner using COA instruments. The PCIOI team has two primary focuses: Developing, assessing, using, interpreting and disseminating COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs) to derive treatment benefit during the clinical development and commercialization of new molecules (Phase 1-4). Performance Outcomes (PerfO) are also covered by the COA team, whom also provides increasing support for technology-enabled outcomes. Supporting the development of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies. Consultation with regulators, payers and key opinion leaders is common. Example research activities for the PCIOI team may include development of a conceptual model of disease through literature reviews, expert clinician interviews and concept elicitation interviews with patients; the systematic selection of COA instruments to measure specific concepts of interest; psychometric assessment of the measurement properties of a COA instrument (reliability, validity, responsiveness etc); development of new COA instruments, including cognitive interviews to ensure content validity; development of briefing books or dossiers for regulatory consideration of COAs for inclusion in product labelling; analysis of textual data from COAs or social media; development of routine clinical practice tools for self-management, shared-decision making and communication; and faithful migration of COA instruments from paper for electronic use. Internal customers include Research and Development (R&D), Health Economics and Value Assessment (HEVA; previously HEOR), Medical Affairs, Market Access, Statistics, and Commercial. Major Responsibilities The COA Scientist is expected to be able to: Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research Collect and evaluate drivers of patients disease- and treatment-related behaviour Examine patient insights on current treatment & perspectives on target product profiles Advise on the use and/or development of COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, validation and dissemination Specific role activities for a COA Scientist include: COA development and use Conduct qualitative and quantitative research to inform development on conceptual disease-models and to support analyses of unmet clinical need and potential therapeutic preferences Provide expert advice on COA measurement needs to cross-functional molecule teams to ensure well designed evidence generation plans are developed and implemented. Ensure these reflect the need for COAs from multiple stakeholders, including (where relevant), regulators, payers, healthcare professionals and patients Develop COA endpoints as appropriate for the clinical development programs. Includes managing research required to support the selection, development and validation of COA measures, including qualitative and quantitative research. Advocate for the role of quantitative and qualitative COA across Sanofi Manage vendors as needed Ensure proper input into evidence generation plans, and effective implementation related to COAs throughout execution, including writing relevant portions of the clinical trial protocols, training investigative site personnel on COA principles and appropriate administration of COAs in the studies. Develop statistical analysis plans for COAs, and with statistics, analyze and interpret the COA results from the clinical trial. C OA summary and dissemination Prepare relevant sections of documentation and communication and questions for regulatory and payer agency meetings, support and/or participate in said meetings, and provide robust evidence in support of submission activities. Prepare abstracts and manuscripts presenting COA results from clinical and COA development and validation studies, aligned with publication strategy Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR and DIA Working Groups, IMI. Participate in creating and delivering education on COAs for internal business partners About You : Experience : Experience of HEOR/CMO pharmaceutical industry, CRO or academic experience, relevant experience in COA. Proven track record in some COA disciplines incl. data analyses, scientific publication & input to clinical trials. Experience of drug development lifecycle research (including real-world evidence (RWE) research) Technical & Soft Skills: Native or native-like English fluency (written and spoken) Willing and able to travel globally Understanding of regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, other local agencies) environment, including joint regulatory/HTA review process Knowledge of the drug development process Strong analytical and synthesis skills of qualitative and quantitative data Excellent understanding of research principles and recent developments in COA Scientific rigor, autonomy and sense of initiative Good interpersonal and communication skills, both written and oral; ability to understand and communicate with representatives from the range of disciplines Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment Ability to work effectively either in small teams or independently Ability to interact and manage external and internal networks Senior level personnel are additionally responsible for: coordinating the function at the portfolio level to ensure optimal integration of external advisory forums. E stablishing broader COA strategy and team updates, as needed to LT. I dentify new opportunities to integrate PRO/COA strategy further upstream in clinical development life cycle (ie Ph I). M entoring of entry level personnel. Education : Relevant advanced academic degree (e.g. doctorate or masters in health economics, clinical psychology, public health, epidemiology, psychometrics). Training in COA methods

About the job This position contributes to the global planning, facilitation, and integration of patient insights & perspectives across the Sanofi pipeline. Patient insights inform pre-clinical and development stage programs about unmet need, patient sub-populations and other factors that influence patient decision making and access to care, including clinical trials. This position is accountable for working closely with multiple internal and external stakeholders to generate, translate and communicate insight learnings for maximal impact to programs and on behalf of patients. As qualitative and quantitative data sources are expanding rapidly, this position requires excellent organizational, interpersonal and problem-solving skills in order to navigate a large matrixed set of stakeholders. Aside from data generation and translation, the position will focus on supporting early patient-focused inclusion strategies that increase opportunities for diverse and underserved populations to more readily participate in clinical trials. Using insights and drawing on best practices, this position will work closely with internal and external stakeholders to develop early diversity & inclusion strategies. These D&I strategies will need to include capacity building recommendations that are sustainable and link to post approval access considerations for teams to establish. Strong collaborations with GPTs, CTT and local Clinical Study Unit personnel are essential for success and meaningful impact. Major Duties/Responsibilities: Develop and manage patient-generated health data to establish patient narratives and insights for R&D indications that focus on key global business geographies aligned with likely commercialization plans (Global to local Glocal approach) Responsible for initiating the integrated patient journey within each program and respective indications Coordinate closely with R&D stakeholders across the pipeline to anticipate, plan and deliver relevant patient insights to shape decision making and support various governances (ORC, RWG/ DWG, IDCC) Responsible for the translation of patient-generated insights into actionable recommendations for relevant R&D functions to shape target patient populations-and the target value proposition. Responsible for the identification & communication of considerations within patient-generated health data that impact study design, patient eligibility, clinical trial operations, logistics and patient support needs Translate patient insights into strategies that accelerate clinical trials through external support programs and avenues to broadly shape inclusion of underrepresented and underserved patients; notably of diverse background. Develop priority therapeutic area expertise/alignment to support knowledge management Ensure ongoing education and awareness of learnings across Sanofi About You: Experience : Demonstrated patient centric approach to job function in past research and/or clinical development activities Experience in Health-related data generation and translation. Clinical trials, inclusive of outcomes and clinical operations. Knowledge and demonstrated experience in patient-focused medicines development principles Knowledge And Skills: Robust understanding of behavioral health science, evolving regulatory patient experience frameworks, health economic and patient advocacy principles. Familiar with the considerations and development of integrated patient journey frameworks Demonstrated experience leveraging analytical data to better understand patient needs and generate evidence to support program / team strategies. Strategic thinker, with the ability to professionally influence, while building new solutions and programs in a team environment (Play to Win) Adept at building consensus and engaging with diverse partners; internally and externally Expertise in stakeholder management and leading in a matrixed environment Outstanding teamwork and influential leadership skills with the ability to work with all levels within an organization, as well as with public stakeholders Technical and soft skills : ability to harmoniously diffuse conflict; excellent communicator, effective presentation skills, good interpersonal skills, negotiation skills, ability to quickly build relationships and trust. Expert knowledge of the pharmaceutical industry, R&D, global clinical trials, RWD, patient advocacy and global healthcare systems Proficiency in Powerpoint, Excel, Sanofi internal systems & public speaking. The candidate must be proficient in English and be able to accommodate flexible working hours outside of the traditional 9-5 day. Education: At least a master s degree in healthcare related field preferred but not required based on experience.

Product Manager Cell & Gene Therapy Development Job Summary : We are looking for a visionary Product Manager to spearhead the development of innovative products for our Cell & Gene Therapy portfolio. This role will focus on designing and advancing novel therapeutic solutions, from initial concept through preclinical and early clinical stages, in close partnership with R&D, clinical, and manufacturing teams. The ideal candidate brings expertise in cell and gene therapy, a knack for translating scientific potential into viable products, and a drive to deliver life-changing treatments to patients. Key Responsibilities : Product Concept Development: Identify opportunities for new cell and gene therapy products by analyzing scientific advancements, patient needs, and market gaps; define product concepts and initial specifications. Development Strategy: Create and manage the development roadmap for new therapies, prioritizing projects based on scientific feasibility, therapeutic impact, and business potential. Scientific Collaboration: Work hand-in-hand with R&D teams to design and refine cell and gene therapy products (e.g., CAR-T, gene editing, viral vectors), ensuring alignment with cutting-edge science. Process Integration: Partner with manufacturing and process development teams to embed scalability, reproducibility, and quality into product design during early development phases. Clinical Transition: Support the transition of products into clinical development by defining target indications, patient profiles, and early-stage trial requirements with clinical teams. Market Alignment: Conduct competitive analysis and stakeholder research (e.g., clinicians, payers) to ensure new products meet market demands and deliver differentiated value. Risk Management: Assess and mitigate risks related to technical challenges, regulatory hurdles, and development timelines, adapting plans to maintain progress. Cross-Functional Coordination: Act as the central point of contact across teams R&D, regulatory, quality, and commercial to drive cohesive product development efforts. Innovation Advocacy: Champion emerging technologies and methodologies (e.g., next-gen vectors, delivery systems) to enhance the cell and gene therapy product pipeline. Qualifications: Education: MS, PhD, MBA in Lifesciences/Biotechnology, Bioengineering Experience:5+ years of product management or development experience in biotech/pharma, with at least 2 years directly involved in developing cell and/or gene therapy products. Technical Knowledge: In-depth understanding of cell and gene therapy development, including cellular engineering (e.g., T-cell therapies), gene editing (e.g., CRISPR), and vector design (e.g., AAV, lentivirus). Skills: Strong ability to bridge scientific innovation with practical product outcomes. Experience managing complex, multi-disciplinary projects in a fast-paced environment. Excellent problem-solving and decision-making skills under uncertainty. Clear communication skills for technical and non-technical audiences. Preferred : Background in oncology, rare diseases, or regenerative medicine; experience with CMC or early-stage regulatory submissions.

CTA Chennai Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and analysis of clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies What You Will Be Doing Assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements Maintain and organize clinical trial documentation, including study files, essential documents, and regulatory submissions Support the preparation of study-related materials, such as informed consent forms and case report forms Work with cross-functional teams to facilitate communication and ensure smooth trial execution Contribute to the tracking and reporting of clinical trial metrics and milestones Your profile Bachelor's degree in a scientific or healthcare-related field Prior experience or strong interest in clinical research KNwledge of clinical trial processes, regulations, and guidelines Excellent organizational and communication skills Ability to work collaboratively in a fast-paced environment with attention to detail What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others Visit our careers site to read more about the benefits ICON offers At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles Are you a current ICON EmployeePlease click here to apply

About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally Main Responsibilities The overall purpose and main responsibilities are listed below: SBO Manager (HEVA) will be functionally aligned to Global HEVA business partners (BPs)/Global HEVA Evidence Synthesis lead and will support execution of multiple activities Manage assigned Evidence Synthesis projects in the assigned portfolio to plan and generate robust health economics and value based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod by working with Global HEVA BPs/Global HEVA Evidence Synthesis lead Work with Global HEVA BPs/Global HEVA Evidence Synthesis lead to manage and execution of quality research projects, economic models, trial design recommendations and other activities in support of programs/products as required Support HEVA BPs/Global HEVA Evidence Synthesis lead in the planning, design, implementation, and completion of innovative evidence-based research programs that are consistent with program/product strategies The research programs developed by Global HEVA BPs will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle Collaborate with Global HEVA BPs/Global HEVA Evidence Synthesis lead to seek opportunities to innovate HEVA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of HEVA evidence to ensure reimbursement decisions optimal access Create complex and specialized strategic content without supervision Develop and maintain TA expertise Develop and review content created by HEVA associates Coach HEVA associates People: (1) Develop and maintain effective relationships with key internal stakeholders including Medical Affairs, Clinical Development, Commercial and Market Access (2) Constantly assist and provide effective feedback to HEVA associates (senior or junior) in developing knowledge and sharing expertise (3) Work effectively with global HEVA teams across various time zones Performance: (1) Manage the HEVA evidence generation projects in collaboration with Global HEVA BPs: Develop research plan to support pre-launch, launch and post-launch evidence for investigational and marketed drugs; Evidence generation plan includes burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, development and analysis of patient-reported outcomes; Provide strategic support with individuals and institutions, which may serve as resources for evidence generation purpose, etc ; Work closely with the HEVA product lead to manage and execute research studies to support the clinical, economic and humanistic value of products; Studies include but are not limited to burden of illness studies, epidemiology, literature reviews, meta-analysis, retrospective and prospective observational studies, economic evaluations, and patient-reported outcomes; Lead development of core value dossier (CVD) and AMCP dossiers under the strategic direction of Global HEVA BPs Process: (1) Develop complex HEVA strategic evidence material (2) Build expertise in the field of HEVA for the assigned Therapeutic area (3) Manage core HEVA strategic evidence generation processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with CVD, the US AMCP dossier, and HEVA contributions as appropriate to other submissions (4) Accountable for adherence to the evidence generation guidelines and other standards relevant to HEVA evidence generation processes at SBO (5) Leverage advanced training delivery tools & techniques thereby enhancing the effectiveness of training delivery (6) Design an overall plan of action basis end-customers feedback & improve course content and delivery Stakeholder: (1) Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables (2) Liaise with these teams to prepare relevant & customized deliverables and ensure milestones and timelines are on track for assigned the projects About You Experience: 8+ years of experience in HEOR for the pharmaceuticals industry, CRO consultancy or academia Soft skills: Demonstrate effective communication, organizational and interpersonal skills; Able to work effectively as part of a multidisciplinary global teams; Able to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law; Ability to handle multiple projects across different therapeutic areas; Ability to work well in a cross-functional team; Understanding of the disease environment and the evolution of the market access landscape and implications for the business; Proven track record working successfully in a project/matrix-oriented environment; Excellent communication skills and ability to understand and present complex information in digestible ways for internal (e g senior management) and external audiences; Strong team spirit, sense of transversality, multicultural awareness and ability to drive matrix teams Technical skills: Strong analytical skills to translate clinical and economic information and messages into payer evidence strategies; Understands reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (e g , providers, patients, health systems); Knowledge of methods and principles of health economics, health technology assessment (HTA) reviews Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree Languages: Excellent knowledge of English language (spoken and written) Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi com! null

Summary The Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH. About the Role Your responsibilities include, but are not limited to: Provide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May be the Program Manager of other associates (e.g.., CSE). May function as study medical monitor Support SR/GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team (SMT), and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient Safety Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for disease areas. Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, GMA, Marketing, HE&OR), and decision boards) Work with BR (Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with additional matters Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise. May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) Minimal Requirements: MD (or equivalent medical degree) is required. Medical Board certification preferred. 4+ years Clinical practice experience (including residency) is preferred Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) is required. 5+ years experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV. 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment Showcase advanced knowledge of assigned therapeutic area Demonstrate ability to establish strong scientific partnership with key partners Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/ clinical development process Have people management experience preferred, this may include management in a matrix environment. Global people management is preferred. Exhibit excellent business communication and presentation skills Possess strong interpersonal skills Adept with excellent negotiation and conflict resolution skills Why Novartis? Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https: / / www.novartis.com / about / strategy / people-and-culture You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Global Scientific Communications Intern, Eli Lilly - Bangalore Hiring " Intern " for our Bangalore office. Experience: Fresher from Academics Global Scientific Communications (GSC) GSC - Intern Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly The purpose of an Intern role is to learn and support teams across GSC Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Learn and support data integrity, scientific editing, encoring, clinical trial registry, Document Preparation, Development and Finalization/Document Management Learn the process of coordinating planning (including organizing/preparing outlines), writing (including first-draft authoring), editing, reviewing and completing disclosures in GSC documents. Learn coordinate quality checks for accuracy, Learn processes across sub-functions and learn effective project management skills to support team members on disclosures across GSC Learn to build/communicate credible writing project timelines. Learn ways of effective communication on project status to stakeholders. Learn therapeutic area knowledge including disease state and compound(s) for assigned project(s). learn to enhance scientific communication skills to align with audience needs and technology/digital evolution. Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Learn and enhance knowledge of guidelines applicable across GSC Gain technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. learn applicable database and other tool (e.g., document management systems) across GSC. Minimum Qualification Requirements: Master s degree in a scientific, health, communications, health outcomes, health economics, public health related field Strong communication and interpersonal skills. Successful completion of DI exercise (a writing exercise is required as part of the candidate evaluation process) Other Information/Additional Preferences: Advanced degree (PhD, MD, PharmD, MA, MBBS) in science, health related field or other appropriate disciplines (economics, epidemiology, health administration, health services, Pharmacoeconomics, statistics other relevant sciences) Demonstrated mastery of verbal and written English skills in the medical, scientific, health outcomes, or technical writing fields. Previous training and experience in disseminating results in clinical, health economics, health outcomes, health literacy, disease management, and/or population health. Understanding in clinical development, clinical trial process, health-outcomes research, or regulatory activities. Clinical pharmacology, therapeutic area, health outcomes, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills. . .

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Duties/Responsibilities Lead/actively participate in departmental and/or cross-functional initiatives geared towards updated technological solutions, process improvements, standards and governance updates etc. and regularly disseminate information to teams and stakeholders. Drive forward a lean SDTM implementation group capable of delivering quality SDTM data early in a clinical trial with innovative transformation solutions. Keep abreast of CDISC industry standards and participate in industry wide technical discussions via conferences and webinars. Represent SDTM programming during internal audits as needed. Managerial Responsibilities: Develop job descriptions and career paths for programmers and effectively forecast resource needs, recruit, manage, develop, evaluate, reward, motivate and retain direct reports, resulting in an increasing level of capabilities within GBDS. Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies. Aligns objectives, feedback and performance evaluation with direct manager. Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback. Holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with Head of Clinical Data Strategy, Systems, Reporting and Analytics regarding promotions, performance concerns, and retention risks. Build inter-departmental relationships and resolve issues as needed. Qualifications Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred. Minimum of 10 years clinical/statistical programming experience within pharmaceutical clinical development. Minimum 5 years of experience in managing technical professionals in a regulated environment. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Description Clinical Operations Specialist Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong Job Responsibilities Safeguarding the wellbeing of research subjects in a medical capacity, ensuring that all procedures are conducted with the highest standards of care and safety Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards, ensuring compliance with all relevant guidelines and regulations Recruiting and coordinating communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study Following applicable regulations globally and by region, ensuring that all activities are conducted in accordance with local and international standards Collaborating with cross-functional teams to develop study materials, including informed consent forms, study manuals, and other essential documents Monitoring trial progress and addressing any issues that arise during the study, ensuring that all problems are promptly identified and resolved Providing organizational related support or service, typically under supervision, assisting with administrative tasks and other support activities as needed Performing routine tasks with some deviation from standard practice, adapting to changing circumstances and requirements as necessary Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education, applying this knowledge to improve study processes and outcomes Qualifications High school diploma or equivalent required Associate's degree or higher in a related field preferred Minimum of 2 years of experience in clinical operations or a related field Strong understanding of clinical research protocols and regulatory requirements Certifications Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred Basic Life Support (BLS) certification required Necessary Skills Excellent communication and interpersonal skills Strong organizational and time management abilities Attention to detail and accuracy in documentation Ability to work effectively in a team environment Proficiency in Microsoft Office Suite and clinical trial management software Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health http://www syneoshealth com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job Summary Roles within Clinical Operations at the S11 level are responsible for ensuring the safe and effective operations of clinical research studies This includes safeguarding the wellbeing of research subjects in a medical capacity, reviewing study protocols, and executing procedures in alignment with protocols and regulatory, health, and safety standards These roles involve recruiting and coordinating communication with clinical trial volunteers and patients, and following applicable regulations globally and by region Collaboration with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study is also a key aspect of these roles Impact and Contribution Roles within Clinical Operations at the S11 level significantly contribute to the success of clinical research studies by ensuring that all operations are conducted safely and effectively By safeguarding the wellbeing of research subjects and adhering to regulatory standards, these roles help maintain the integrity and reliability of clinical trials The coordination and communication with clinical trial volunteers and patients ensure smooth and efficient study progress Collaboration with cross-functional teams enhances the development of study materials and the resolution of any issues, ultimately contributing to the advancement of medical research and the development of new treatments Core Focus Safeguarding the wellbeing of research subjects in a medical capacity Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards Recruiting and coordinating communication with clinical trial volunteers and patients Following applicable regulations globally and by region Collaborating with cross-functional teams to develop study materials Monitoring trial progress and addressing any issues that arise during the study Providing organizational related support or service, typically under supervision Performing routine tasks with some deviation from standard practice Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education

Provide support for Global Safety literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements. Ensure timely production of key deliverables including but not limited to: Screen and review literature search results (articles/abstracts/citations) for purposes of ICSR identification Triage literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria Demonstrate GSK values Be proficient in search strategy activities for literature surveillance. Demonstrate expertise in quality checks for literature articles triaged by junior team. Develop and share pharmacovigilance and literature surveillance knowledge and experience with team Recognize potential issues, collaborate with team to resolve. Identify or participate in continuous process improvement activities related to area of responsibility or as requested We are looking for professionals with these required skills to achieve our goals: Pharmaceutical industry experience (eg, drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions with appropriate guidance from senior team members or manager Good attention to detail. Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Computer proficiency, IT skills, the expertise and ability to work with web-based applications Good level of flexibility and ability to prioritize work Good/Highly developed interpersonal, presentation and communication skills Preferred Qualifications: bachelors Degree - Life sciences, Pharmacy, Medical or pharmacology degrees Preferred: masters degree or higher in Health Sciences. Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and we'll-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness

Site Specialist II - India, Bangalore / Chennai - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Site Specialist II to join our high-performing and collaborative Site Activation team at ICON. As a Site Specialist II, you will play a critical role in the start-up, maintenance, and contract management activities for clinical trial sites. This is an exciting opportunity to work across essential site-level functions that support the timely and compliant activation and maintenance of clinical sites globally. What You Will Be Doing: Supporting Study Start-Up activities , including review of essential documents, green light process management, and site activation readiness. Handling maintenance tasks such as customization of site-specific Informed Consent Forms (ICFs), coordination of translations, EC/IRB submissions, and documentation in eTMF systems. Assisting in the contract process , including understanding site contract workflows, managing contract amendments, participating in negotiations, and ensuring finalization of executed agreements. Collaborating effectively with cross-functional teams and stakeholders to ensure timelines are met and compliance is maintained. Communicating clearly and confidently with both internal and external teams, demonstrating excellent written and verbal communication skills. Working flexible hours to support global operations. Your Profile: Bachelor s degree in life sciences, business, or a related field. Solid understanding of study start-up processes, maintenance activities, and contract management in clinical trials. Strong organizational skills and the ability to manage multiple priorities with attention to detail. Excellent communication skills both written and verbal with the ability to liaise effectively across global teams. Familiarity with ICF customization, translation workflows, IRB/EC submission processes, and contract negotiations is highly desirable. Willingness to work flexible shifts to align with global team needs. #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

The User Role & Access Management Specialist within our Research & Development (R&D) team will play a critical role in ensuring secure and efficient access to our systems and data. Your responsibilities include: Access Control and User Profiles: o Analyze user access needs and determine appropriate access levels, including creating standards for various roles across our teams and systems. o Set up and maintain user profiles, roles, and access rights in our R&D systems. o Manage the demand process and the follow-up of demands and incidents. o Support the user access cleaning and compliance process. o Contribute to the implementation of Role and Access User Management Process and data for the deployment of new global R&D Applications across functions. Monitoring and Compliance: o Monitor access activities to identify any issues, unauthorized access/ attempts, system outages or other issues impacting accessibility and security o Perform regular audits to ensure access rights align with job roles and responsibilities. o Ensure compliance with quality/ security standards and data privacy regulations. o Contribute to incident resolution with Digital function. o Contribute to simplify and accelerate the process. o Generate KPIs and dashboard. Collaboration and Communication: o Develop and maintain effective relationships with all internal / external customers: internal critical stakeholders (R&D and Digital community) and external stake holders (CROs, contractors, Investigator sites) o Support User Role and Access Management Team Leader in understanding of stakeholders needs & expectations and provide end to end solutions for User Roles & Access Management global activities across R&D o Liaise with R&D system owners and Digital Teams to manage new and existing user roles. o Act as the key point of contact for all questions and business-related issues for User role o Resolve access issues promptly and maintain all service level agreements. o Collaborate with Digital and security teams to improve access management systems. o Contribute to Roles and Use Access Management R&D Network o Develops weekly and monthly status reports for management , capacity planning and new projects. Documentation and Training: o Develop and maintain documentation related to roles and access management processes (Operational Business Documents, & Training documents. o Train managers & internal and external requesters / end-users o Provide training to users on access management policies and procedures. In summary, you'll safeguard our critical R&D data by managing user access effectively About you Experience in previous system role and access management or ownership experience required. Ideally trained in various Clinical, Development and regulatory systems including Veeva Vault, RIMs, CTMS Tools, iEnvision, etc Ability to quickly learn new systems, interfaces and tools. Familiarity with pharmaceutical processes, product development, and regulatory requirements. Understanding of drug development stages, clinical trials, and manufacturing processes. Effective verbal and written communication to convey system related information. Collaboration with R&D system owners and stakeholders. Strong problem-solving skills for evaluating proposed changes. Identification of risks, benefits, and potential obstacles. Experience working cross-functionally with R&D teams and Digital teams. Comfort with evolving processes and frequent adjustments during development. Bachelor s degree or equivalent, specifically in the digital or IT space Excellent communications skills, both verbal and written in English

Project Manager, FSA (Feasibility, Site Activation) Role Summary: Accountable for driving and accelerating the activation of global investigative sites in line with, or ahead of, the studys contractual timelines, within budgeted resources, with quality output, and exceeding sponsor expectations. Accountable for the overall coordination, implementation and completion of site activation or maintenance activities for assigned projects of work in line with ICON/sponsor SOPs as appropriate, including regulatory/ethics, site contracts, essential documents, and site activations. Interacts with internal teams and stakeholders, as well as sponsor teams and stakeholders as needed. Responsibilities: Lead studies with highest quality standards to exceed customer expectations. Review study and partnership budgets for proposals and sales as needed. Drive assigned studies to meet KPIs and delight customers and sites Act as customer point of contact for assigned studies; resolve study issues and drive exceptional customer delivery Represent FSA at audits and inspections Participate in Business Development opportunities to support the growth of the assigned portfolio, function, and/or region/country(ies) Travel (approximately 10% depending on country structure and direct report levels) domestic and/or international What you need: Bachelor s Degree 3-6 years of experience in a Clinical Research environment, focusing on Start Up experience Project management skill set Understanding of regulatory and submission processes in many different countries Excellent written and verbal communication Ability to work to tight deadlines Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Contracting deliverables Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials Work with partners to develop and oversee the global site budget process Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline Collaboratio n Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives Compliance with Parexel standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Balance of general business, compliance, finance, legal, and drug development experience Precise communications and presentation skills Ability to plan, identify and mitigate risks to site contacting timelines Ability to lead by influence rather than positional power to accomplish critical deliverables Success in working in a highly matrix based organization Fluency in written and spoken English is required Knowledge and Experience: Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities Knowledge of the principles, concepts and theories in applicable business discipline Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred Education : Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

We are seeking a highly skilled Biostatistician to join our team in Hyderabad. In this role, you will provide expert support and functional and technical knowledge to ensure the scientific integrity and validity of clinical development, early development, and/or research projects. You will play a crucial part in the full lifecycle of producing key data and reports, from evaluating requirements to coordinating validation and providing quantitative analytical support. This position also involves providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. You may also contribute statistical expertise to research or other R&D areas. Additionally, you'll be responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of various data-related tools and processes. About the Role: Key Responsibilities Study Level Responsible for all statistical tasks on assigned trials, performing mid- to high-complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, and reporting activities. Contribute to planning and execution of exploratory analyses, PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, and other drug development activities as required. Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions, explaining statistical concepts clearly to non-statisticians and providing adequate statistical justifications for actions/decisions/statements when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level May be a core member of an early project team for a low-complexity program, representing Biostatistics and Pharmacometrics as part of the development plan with oversight. Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision-making in assigned indications/programs with oversight. Collaborate cross-functionally (e.g., data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization, and tracking of program-level biostatistics activities and effective partnership with vendors. Significantly contribute to project team preparation for Health Authority (HA) Advisory Committees and meetings. Franchise or Global Line Function Level Significantly contribute to initiatives at the global line function level. Enterprise Level Actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and acceptance of innovative methods within and outside the organization, through scientific collaborations, publications in scientific peer-reviewed journals, presentations, and chairing sessions at professional meetings. External Level Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Role Requirements MS (in Statistics or equivalent) with 7+ years of relevant work experience OR PhD (in Statistics or equivalent) with 3+ years of relevant work experience . Fluent English (oral and written) with good communication and presentation skills. Ability to influence decisions that directly impact the trial/project and team's ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in the use of statistical software packages (e.g., SAS, R ). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and/or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Adherence to good business ethics.

Althera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Clinical Project Manager to lead and oversee clinical trials for our drug development pipeline. Role & responsibilities Develop and execute comprehensive clinical project plans, timelines, and budgets in alignment with company objectives and regulatory requirements. Oversee all aspects of clinical trial conduct, including protocol development, site selection, investigator initiation, patient recruitment, data management, and safety monitoring. Prepare and present clinical study reports, regulatory submissions, and other relevant documentation. Ensure adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant regulatory standards. Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and medical affairs, to achieve project milestones. Build and maintain strong relationships with key stakeholders, including investigators, CROs, and regulatory authorities. Monitor and manage project timelines, budgets, and resources effectively. Identify and mitigate project risks proactively. Proficiency in clinical trial management software and systems. Required Qualifications: M. Pharma/Ph.D Min. 8 to 12 years of experience in clinical project management within the pharmaceutical industry. In-depth knowledge of EU regulatory requirements for drug development and clinical trials Strong understanding of clinical research methodologies and statistical principles. Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and management. Strong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: - Experience in OSD product development and clinical trials. Knowledge of global regulatory requirements.

Medical Writer II (CSR Narrative exp Only) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications - Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing - Good Experience of independent authoring and reviewing CSR Narratives only. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Medical Writer II (CTT) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Medical Writer II (Clinical Trial Transparency) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Principal Biostatistician (Non-Clinical Statistician) Job Responsibilities o Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably o design of experiments feasible under given lab conditions, o support of sample-size calculations and application for animal testing licenses, o randomization, o data transfer into appropriate stats software, o interpretation of results o Takes statistical responsibility for one or more standard experiments o Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects o Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects o Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI o Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results o Works independently at routine and complex statistical questions and tasks o Develops and implements standard processes for the analysis of routine experiments o Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers

Sr Medical Writer (Redaction) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities - 1. Authoring andQuality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2. Additional Activities Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s) Qualifications - We are looking for 4-8 years experience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management. - Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected. Qualification Requirement - Educational qualifications: A minimum of a scientific graduate degree in life sciences. - Good knowledge of regulatory requirements or guidance pertinent to the service line. - Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills - Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required. - Person should understand & comprehend protocol and clinical study report from disclosure perspective. - Good understanding of clinical trial disclosure fundamental - Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working - Ability to build rapport/ relationships with project-specific client colleague Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Data Analyst II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Work independently to solve open-ended questions. Design and analyze tests and experiments. Maintain documentation of analytical processes and projects. Build, maintain, and improve performance dashboards leveraging customer feedback for use and accessibility. Advise clients on relevant best practices and ensure the data is easily retrievable for their review. Support data quality and understanding customer needs as they evolve. Mentor and coach junior team members. Support site advocacy group meetings by inviting PIs, discussing blinded protocols, collecting feedback, and managing scheduling, hosting, and meeting minutes. Develop and manage capabilities decks twice annually, along with bespoke slides and marketing information sheets using Power BI data. Track and analyze business development outcomes through opportunity trackers, monitoring RFP success rates, regulatory approvals, and win rates. Monitor customer satisfaction by reviewing feedback from the EM team and facilitating monthly cross-time zone communications. Oversee product approval tracking, ensuring visibility into product lifecycle status and final approval outcomes. Qualifications Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

IMS Specialist II (Customer Support) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Processes investigator payments by: Maintaining the investigator payment portion of the IMPACT and Medidata System. Reviewing data with project manager for quality and completeness. Processing and creating approved grant payment requests via the IMPACT and Medidata system and forwarding or interfacing with A/P; and Distributing investigator payments to respective sites Creates, maintains, and reconciles MS Excel Project Grant Tracker as necessary. Reviews and interrogates Clinical Trial Agreements (CTAs) and CTA amendments to ensure payments are made according to the documented payment terms and schedule. Discrepancies should be escalated to their line manager or the appropriate project team member as needed. Communicates with site to secure invoices and resolve queries Communicates with IMS Lead and IMS 1 on resolution and processing of invoices Confident to communicate with sites in global locations both in writing and on the telephone Escalates to clinical team where appropriate to follow up on invoice discrepancies, past due invoices and to request refunds from sites. Ensures proper account and project coding are applied to third party invoices as it relates to investigator payments. Assists with customer audits of site payments and sponsor deposits. Trains and mentors less experienced staff members on departmental Standard Operating Procedures(SOPs), processes, tools, and templates. Minimal travel may be required(up to 25%). Works with sponsor systems and applications as required by the project. Qualifications BA/BS degree in Business, Accounting, or equivalent combination of education and experience. Proficiency in Microsoft Office Suite(Word, Excel, PowerPoint), email, and voicemail. Excellent written and verbal communication skills. Excellent English. Other foreign language proficiency preferred. Ability to organize and prioritize work to meet deadlines in a dynamic environment. Above average attention to detail, and interpersonal skills with a team-oriented approach. Oracle experience preferred but not mandatory. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Principal Biostatistician Job Responsibilities

Principal Medical Writer (CTT) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH, ,National registries (DIMDI)) - CTT Data base experience ( Disclose, Prime, PRS, EudraCT) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2. Additional Activities Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s) Qualifications We are looking for 8 years experience medical writer who will be involved in CTT/redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management. Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected. Qualification Requirements - Educational qualifications: A minimum of a scientific graduate degree in life sciences. - Good knowledge of regulatory requirements or guidance pertinent to the service line. - Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills - Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required. Person should understand & comprehend protocol and clinical study report from disclosure perspective. - Good understanding of clinical trial disclosure fundamental - Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working Ability to build rapport/ relationships with project-specific client colleague Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.