1157 Clinical Research Jobs - Page 39

Manager - Business Development (Clinical Research)Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 8 - 12 years of experience in the BA BE/CRO industry as a Business Development. Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research Location - Madhapur, Hyderabad, Telangana, India

Prime Indian Hospitals is looking for Doctors (Specialists & Consultants) to join our dynamic team and embark on a rewarding career journey We are seeking highly skilled and compassionate specialists and consultants to join our growing medical team. You will provide expert medical care and contribute to a positive patient experience. Responsibilities Provide high-quality patient care. Diagnose and treat medical conditions. Collaborate with other healthcare professionals. Maintain accurate patient records. Participate in continuing medical education. Qualifications Medical Degree (MD or DO). Board certification in relevant specialty. Excellent communication and interpersonal skills. Strong diagnostic and treatment skills. Current medical license.

The Medical Information Specialist (MIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints. Essential Functions Include:Medical Information service delivery Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma s pharmaceutical clients. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices. Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems General Provides after-hours coverage on a rotated basis subject to business requirements. Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment. Complies with the Company s health and safety policies. Other activities as assigned as delegated by the Manager. Qualified candidates must have: Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills. Ability to write in a fluent and grammatically correct manner in the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.

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. Job Title/Role : Sr. Support Manager, Interactive Response Technology Department Name/Functional Area : Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT Location : Office based . Position Summary This position supports multiple IRT studies (system development, study management, change management, audits and data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives. Duties/Responsibilities Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles. Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. During IRT maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved. Maintain vendor performance quality events in ADI log. Act as off hours audit/inspection support contact as needed to support rest of world. Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply P&L and IRT vendors. Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team. Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team. Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency. Support key department and enterprise level initiatives as part of the IRT representative. Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements. Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes. Ensure effective system access and functionality across all countries and all user locations. Complete all assigned training by due date Support unblinding activities as needed. Ensure on time development of IRT data transfers with vendors and/or third-party vendors. Ensure eTMF compliance at the study level in accordance with group and BMS guidance. Engage and support study and CSMT project teams as deemed necessary. Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms. Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals. Reporting Relationship This position reports to the Associate Director, Interactive Response Technology (IRT). Qualifications Minimum bachelor s degree Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.) Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint. Clinical Research experience Working knowledge of IRT Working knowledge of Clinical Trial Management Systems Working knowledge of clinical supplies Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards. Exposure to working in a GMP / GCP environment and with regulatory audit teams. Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required Comfortable working with a global team, partners and customers in a change agile environment MS Project, MS Visio, or any other requirements visualization and analysis tools) 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:

Newlife Fertility Centr is looking for Embryologist to join our dynamic team and embark on a rewarding career journey Performing Invitro Fertilization Procedures. Conducting regular assessments of health and development of embryos. Maintaining records and samples to ensure testing and laboratory work remains consistent. Monitoring and maintaining quality control. Writing, reviewing, and improving embryology standard operating procedures. Good research skills. Strong interpersonal skills. Qualification : A Bachelor Degree in biological science, biomedicine, clinical lab settings or biochemistry. Experience : Minimum 1 year experience is required.

The Global Program Associate Director (GPAD) provides project management expertise and operational support for global drug development programs. As a member of the Global Program Team (GPT), the GPAD maintains accurate plans, documentation, and resource forecasts, and helps to ensure efficient day-to-day operation of the GPT, resolve program issues, and facilitate alignment across sub-teams and line functions. The person in this role is a member of the GPM team for a program and is specifically responsible to: Contribute to cross-functional strategy and project plan scenario generation Generate and maintain key project level documents including accurate project plan and forecast Proactively identify, track and manage project risks and issues Monitor and track development activities, forecast, and timelines at high quality Facilitate GPT dynamics, effectiveness and communication Support creation and alignment of executive communication of project progress, changes and risks The GPAD is a project management professional with expert planning, tracking, and financial reporting skills, and advanced technical skills in the use of Excel and Gantt charts. The GPAD may deputize for GPED or GPD (as applicable) and may lead or participate in ad-hoc crossfunctional task forces and sub-teams. In some cases, a GPAD may be dedicated temporarily to a non-drug GPM initiative. Job Description Major Accountabilities: Programs/ projects Contributes to the development of the program/project strategy and Target Product Profile (TPP) and partners with the GPED/GPD (as applicable) and GPT members to translate the strategy into a realistic Integrated Development Plan (IDP) incl. Gantt chart; ensures consistency of both strategy and IDP with TPP Works with GPT members and Line Functions to ensure cross-functional alignment of TPP and IDP and consistency with individual functional plans Contributes to GPM deliverables associated with the program/project (incl., TPP, IDP, One Pager, Gantt charts, risk register, GPT minutes) Coordinates preparation and compilation of strategic documents and preparations for project tollgates in collaboration with the GPT and GPED/GPD (as applicable) Proactively identifies project risks and issues and contributes to development of mitigation strategies Supports communication of program/project status, changes and risks/issues horizontally and vertically in a proactive, transparent and timely manner Supports preparation of comprehensive program/project recommendations and presentations for governance boards May lead or participates in ad-hoc cross-functional sub-teams and task forces to develop strategic options and scenarios or to address and resolve issues May deputize for the GPED or GPD (as applicable) Operations Manages GPT meeting logistics and prepares high quality GPT agendas and draft minutes in a timely manner. Records action items / decisions and liaises with GPT members on follow-up activities and deliverables Along with Finance, assembles and monitors project financial forecasts and addresses variances Drafts program/project/financial information provided to e.g., governance boards, portfolio management, finance function and Investment Committee Supports timely executive communication of project status as required by the organization (e.g., One Pager, Executive Gantt chart, monthly IMB/GLT updates, GPT minutes). Leads generation and maintenance of a complete and accurate project plan and forecast in the enterprise planning system (e.g., Horizon). This includes liaising with partner functions to ensure a realistic plan that reflects the strategy. Challenges the schedules and financial forecasts provided by the functions to ensure feasibility Monitors execution of cross-functional project activities and tracks progress versus GPT objectives (timelines, forecast) Ensures project level risks are assessed on a regular basis by GPT and documented and tracked in enterprise planning system (Horizon) Team performance Partners with GPH and GPED or GPD (as applicable) to enable a high performing team culture based on the Novartis values and behaviors, the expertise and contributions of the GPT members, shared responsibility, and the coordination of work towards a common goal Contributes to establishing GPT objectives and tracks progress of objectives Builds trusting relationships with GPT members Collaborates with GPT members to identify key program risks/issues and brings to GPT for deliberation and decision on resolution/mitigation At level of select workstreams able to synthesize perspectives from different Line Functions to generate draft strategy and plan Leadership Drug Development and Project Management Contributes operational drug development knowledge and project management experience to team discussions Supports GPT with strong program management skills in the areas of planning, tracking, scenario generation, contingency development, critical path analysis, and risk management Actively identifies and develops best practices for project management and implements and shares accordingly Demonstrates behavioral core competencies of proactivity, resilience, personal integrity, commitment to excellence, critical/analytical thinking, courage and creativity, agility and influence Collaborates with the Global Program Management Office (GPMO) to strengthen project management and implement processes, tools, and best practices Participates in initiatives to develop and implement process changes within and outside of GPM Keeps up to date on organizational changes and acts as strong supporter of organizational change; supports implementation of changes within GPTs Peer coaches new GPADs for effective on-boarding into role. Key Performance Indicators: Achievement of GPT objectives and key project milestones Quality and accuracy of plan and forecast in enterprise systems Quality of project-/ program-level documents incl. TPP+, IDP, One Pager, Executive Gantt chart, GPT minutes . Quality of draft executive communication of project progress and risks. Education: (minimum/desirable): Masters or Doctorate in life sciences (or MBA with bachelor s degree, or equivalent experience in life science Experience: 1. 5+ years pharma industry experience 2. 5+ years or equivalent multi-/cross functional team experience 3. Previous track record of success in working with large scale and complex international and multidisciplinary drug development teams 4. Intermediate knowledge in drug development process 5. Strong project / program management skills 6. Expert planning and tracking skills, ability to use proper tools in program management 7. Intermediate knowledge of regulatory and business requirements 8. Well organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities and self-management 9. Strong interpersonal and communication skills (written and verbal) for bridging across diverse, cross functional, multi-national, geographically dispersed teams Skills Desired Adaptive Strategy And Innovation, Clinical Research, Cross-Functional Teams, Drug Development, Financial Management, Interpersonal Communication Skills, Microsoft Project, Npd (New Product Development), Pmi (Project Management Institute), Pmp (Project Management Professional), Program Management, Project Delivery, Project Execution, Project Life Cycle, Project Planning, R&D (Research And Development), Resource Allocation, Risk Management, Senior Management, Stakeholder Management, Time Management Skills, Waterfall Model

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Product Development Job Sub Function: R&D Digital Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India Job Description: Integrated Data Analytics and Reporting (IDAR) Principal Engineer Digital Health Enablement* (*Title may vary based on Region or Country requirements) Position Summary: The Principal Engineer Digital Health Enablement is responsible for shaping the interfaces between partners, system and process for capabilities administered by Enabling Analytics & System Excellence EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS). The Principal Engineer Digital Health Enablement within CTM Solutions will oversee end to end system planning, administration, oversight and related processes for capabilities supporting clinical trial document management/TMF, study management and oversight. The Principal Engineer Digital Health Enablement will oversee end to end system planning, administration, oversight and related processes for capabilities supporting patient engagement, site staff enablement, clinical staff training. This includes driving customer enablement and innovative solutions for the supported capabilities: collaborating across Product Groups and including business partners, IT and suppliers, metrics oversight, user administration and support, system integrations management, continuous improvement and change management. The Principal Engineer Digital Health Enablement delivers operational results and assists with development of digital initiatives that innovate product development, meet organization standards, and drive digital strategy. Provides leadership, management, and/or coaching to a multidimensional R&D organization to ensure workforce effectiveness of the overall operations of the business. Principal Responsibilities: Lead the identification and implementation of technology solutions designed to optimize processes and deliver measurable value. Lead continuous improvement initiatives, identifying new tools, processes, or technologies that enhance study team, patient and site engagement strategies. Troubleshoot system-wide issues, serving as a point of escalation for technical challenges that impact CTM Solutions and/or or I&PS activities. Ensure robust project management practices, including developing business cases, project plans, and financial oversight, are applied to solution delivery. Partner with IT and vendors to ensure strong system change control strategies, minimizing disruption and aligning updates with best practices. Manage financial planning and budgets, ensuring efficient allocation of resources for technology implementation and continuous improvement. Lead a high-functioning and diverse team to enable industry-leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders. Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively. Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks. Provide ongoing training and support, ensuring clinical study teams have the resources they need to maximize tools and processes. Engage in System/Process audits and Sponsor Inspections as a subject matter expert for supported capabilities. Lead and/or contribute to cross-functional strategic projects Train and mentor colleagues. Serve as Owner for CTM Solutions or I&PS capabilities Represent on/lead organizational initiatives Principal Relationships: Internal: Global Development Departments and Leadership; IT; R&D Quality; MedTech; J&J Legal, J&J Finance External: System Vendors; Investigator Site Staff; CRO points of contact and resources; Regulatory Inspectors; Industry Peer Networks Education and Experience Requirements: A minimum of a bachelor s degree or equivalent is required, preferably in Health, Science, Information Technology or another relevant field. A minimum of 6+ years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required. Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required. Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required. The ability to partner and influence people at all levels of the organization is required. Superior communication, business partnering, problem solving, and prioritization skills are required Project Management or Process Improvement certification is preferred. Other: Ability to travel up to 10% of the time (Domestic/International) is required. Ability to communicate effectively in English. Global business mindset.

Company Description AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Medical Science Liason Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to Abbvie initiatives in assigned therapeutic areas. Executes against the Medical Affairs plan for India. Provides scientific education and training initiatives across Abbvie Oncology portfolio. Plans and leads scientific communication with key therapy leaders and stakeholders, organizing advisory board meetings, facilitating clinical trials, and serving as the medical resource for both external and internal stakeholders. This position is a non-promotional role. The primary focus is providing Healthcare Professionals with fair and balanced scientific information. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Abbvie. Works closely with other Abbvie personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met. Key Responsibilities Area As an internal medical / technical / scientific resource, leads medical affairs objectives in the affiliate country. The role requires competency in practical aspects of patient care, and the ability to use medical and scientific information to facilitate engagement of physicians and others in the clinical and basic scientific issues relevant to Abbvie s products. Responsible for maintaining annual expenses within assigned budget parameters. Responsible for accurate and timely documentation of medical lead activities. The employee must conduct their work activities in compliance with all Abbvie internal requirements and with all applicable regulatory requirements. Abbvie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. Identify, develop and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on Abbvie products. Work closely with the Commercial leaders for business planning , Therapeutic leads & Dir, Medical Affairs to set priorities, and activities. Upon request, present data on Abbvie products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. Support research initiatives as requested by Abbvie R&D, Clinical Operations, and Medical Affairs Departments. Serve as internal medical and scientific resource to assigned Abbvie therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. Conducts on-going training to medical affairs, field sales and other internal personnel as required. A high level of travel / field time is to be expected within this position (approximately 60% of time spent outside the office). This role will also serve as the local representative of the Global Medical Office associated functions. (eg PV, HEOR etc) Qualifications Qualifications Requirements Minimum 2-3 years post-qualification work experience in Medical affairs function. Experience working within the pharmaceutical industry or within clinical research is preferred Experience of working collaboratively and cross-functionally in a matrix structure, supporting multiple stakeholders Demonstrated ability to learn quickly and convey clinical and non-clinical technical information effectively to individuals with varying degrees of scientific acumen. Demonstrated strong presentation and teaching skills with ability to effectively share information with others Demonstrated ability to develop and maintain strong relationships; to lead & engage Experience applying analytical skills, to critically evaluate and effectively communicate key clinical data Experience working with technology, including systems such as Microsoft Office.

Reviews the doctor s notes and the drug chart and acts as required Prepares nursing care plans and renders effective bedside nursing care Ensures medication safety and patient safety protocols are practiced. Manpower deployment prepares duty roster; assigns nursing and anesthesia technician as per requirements. Ensures efficient staffing, material, and equipment availability. Ensures nurses are competent and can handle tasks assigned to them. OT Scheduling: plans following day checks the booking register a day before surgery, notes and actions special requirements, co-ordinates with the surgeon & anesthetist; plans manpower, equipment and ensures OT is fully prepared for the specific surgery. Responsible for ensuring additional requirement of resource, blood procurement, equipment is made available Checks to ensure medications, consumables, instruments and equipments are available for the surgery. Ensures all equipment are fully functional; conducts random checks of surgical and laparoscopic instruments ensuring they are functional. Competently handles all equipment used in patient care; ensures team is competent in usage; ensures equipment is serviceable and readily available. Ensures documentation for all completed surgeries is updated and accurate. Maintains emergency stock of medications and consumables in OT. Co-ordinates with OT technician, biomedical team and housekeeping staff. Responsible for material management and cost control documentation, Indenting, receiving stock, storage and usage. Ensures no wastage and misuse. Responsible for narcotic management storage & documentation of usage. Aware of NABH & Nursing excellence standards and ensures implementation. Job Category: Nursing Job Type: Full Time Job Locations: Bangalore Experience: 7-10years Qualification: GNM / B. Sc (Nursing)

Job Overview Provides high quality, on-time input to client projects in the Market Access Analytics(aka Payer Analytics/Managed Market Analytics) with Patient level data LAAD(aka APLD, Patient Level data). Assignments range in complexity from intermediate analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams. Essential Functions Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions. Assists in the development of detailed documentation and specifications. Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions. Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience. Develops, and may present, complete client deliverables within known/identified frameworks and methodologies. Proactively develops a basic knowledge of consulting methodologies and the Payer Analytics space through the delivery of consulting engagements and participation in formal and informal learning opportunities. Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals. Qualifications Bachelors Degree Req 4-7 years of related experience Req Works willingly and effectively with others in and across the organization to accomplish team goals. Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline. Knowledge of consulting methods, tools and techniques- SQL/Python, related to one s functional area. Knowledge of US Healthcare stakeholders and their key interactions, roles and responsibilities. Knowledge and understanding of the Patient level data sets for US Healthcare. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

The Manager, CSAR - Electronic Data Interchange and Acquisition What you will do Let’s do this. Let’s change the world. About The Role The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

About The Role We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence stakeholders and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is complied with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Study build and Edit check development Programming Languages ? Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with experience range of 9-13 years Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - SAS Edit Check Programmer What you will do Let’s do this. Let’s change the world. The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Proficient in SAS edit check programming Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience. Master’s degree and 4 to 6 years of experience. Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Manager, CSAR – Custom function Programming What you will do Let’s do this. Let’s change the world. We are looking for a dedicated individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence collaborators and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and Custom function programing Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related field Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Sr Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans. This role involves working closely with business stakeholders, system owners and security analysts to ensure technical requirements are collated, documented and implement to ensure the success of our internal and external business partners. You will collaborate with the Product Owner and other Business Analysts to maintain an efficient and consistent process, ensuring the best quality deliverables from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Own expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and business problems and work with cross-functional owners to develop long-term solutions Maintain accurate documentation of configurations, processes, and changes Own technical solutions and maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trial. E.g. Rave, CTMS, Veeva Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum), Change management and problem management Excellent problem-solving skills and a committed attention to detail in finding solutions. Good-to-Have Skills: Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Skilled in providing oversight and mentoring team members. Excellent analytical and gap/fit assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability Basic Qualifications: Degree with 2-5 years of experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices ? EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? About The Role : Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude. Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) OperationsRequirements: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? About The Role : Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude. Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) OperationsRequirements: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? About The Role : Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes. Conducting PEPs (Politically Exposed Persons) screening and adverse media checks Proven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail. Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience. Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities. Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude. Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for? Know Your Customer (KYC) OperationsRequirements: Educated to Degree Level Familiar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process. Relevant financial service experience, ideally within risk, compliance or financial crime. A good understanding of effective risk management Experience of working with high-risk client groups Knowledge of the regulatory environment is highly desirable Strong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systems Detail oriented, with the ability to work independently and multi-task effectively Excellent written and verbal communication skills Flexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Role & responsibilities : Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) are followed. 2. Conduct planned studies as per protocol requirements, quality system procedures and SOPs. 3. Review of pre study health records. 4. Obtain written informed consent before each Volunteer participation in the trial. 5. Ascertaining that clinical data is complete, accurate and is recorded as per protocol and SOP requirements. 6. Assessment and documentation of UDS reports & additional test reports. 7. Documentation of eligibility status. 8. Verification of daily Temperature log , Urotherm reading , Emergency medication kit documentation and expired medication discarding. 9. Briefing research staff on conducting the trail and Group briefing of ICF to volunteers 10. AE, SAE management, reporting and documentation. 11. Monitoring the trial throughout its duration. 12. Verifying the data entered on to the CRFs is consistent with source data. 13. ICU maintenance including management of emergency conditions. 14. Monitoring of Vitals documentation, ECG, Phlebotomy and X-ray procedures. 15. Verification of X ray films and X ray report destruction. 16. Post study reports assessments and documentation. 17. Completion status of CRFs and documentation. Secondary Responsibilities: 1. Review of ICFs, CRFs. 2. Screening and Evaluation of Volunteers for study participation. 3. Monitoring of drug administration to volunteers. Preferred candidate profile : Gender Preference : Male Industry : Clinical Research || BA, BE Studies Night Shifts : Yes No of Vacancies : 3 Contact : Ms Keerthana - 9160712930

Madurai HCL Tech is hiring candidates for PMS Analyst role. We are looking for candidates from B.E/B.Tech. Mechanical graduates who is interested in working for Medical domain. The 1st level of interview will be a Face to Face in Madurai office premises. Looking for candidates who passed out their Mechanical graduation with Engineering in 2022/2023/2024. Interested candidates please share us your updated resume along with the below details in mail to keeshouley.m@hcltech.com. Candidate Name: Candidate DOB: Graduation: Passed out year: Current location: Native location: Total Years of Experience: Relevant Years of Experience: Current CTC: Expected CTC: Notice Period: Interested to come for walk-in interview to Madurai premises: Regards, Keeshouley M

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.

We are seeking a motivated and detail-oriented Clinical Research Associate (Fresher) to join our clinical research team. You will assist in the planning, monitoring, and documentation of clinical trials while ensuring compliance with regulatory guidelines and study protocols. Key Responsibilities: Assist in the coordination and monitoring of clinical trials across various sites. Ensure accurate collection, documentation, and reporting of clinical data. Support investigators and site staff with study protocols and procedures. Verify compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. Help in preparing study-related documents and reports. Participate in site visits, audits, and data review activities. Assist in conducting clinical trials and analyzing research data.