260 Clinical Development Jobs

As a Biostatistician Technical Expert - Clinical Statistics at Sanofi, Hyderabad, you will play a crucial role in leading and overseeing statistical support for a team of senior and principal biostatisticians. Your responsibilities will include being accountable for statistical aspects and deliverables of several early/late phase studies, providing directions and guidance in project assignments, and interacting with other internal functions. You will also apply advanced statistical methods while ensuring scientific integrity to project work. You will support the clinical development plan, clinical study design, study setup, and conduct. Additionally, you will conduct or oversee the execution of statistical analyses, prepare statistical methods, and provide statistical insight for interpretation and discussion of results sections for the clinical study report and publications. As a biostatistical consultant, you will mentor junior statisticians and maintain knowledge of developments in biostatistics, clinical trial methodology, and regulatory requirements. Your role will involve proposing, preparing, and performing exploratory and ad-hoc analyses relevant to study objectives, as well as coordinating with study programmers for statistical analyses. You will contribute to process optimization, provide inputs to statistics and quality standards, and represent the statistics team in various initiatives. To be successful in this role, you should have 7+ years of experience in the pharmaceutical industry with a Master's degree or 5+ years with a Ph.D. You should possess a broad knowledge of advanced statistical concepts, strong project/study management skills, and proficiency in SAS and R languages. Additionally, experience in project management and development is preferred. Join us at Sanofi to bring the miracles of science to life and grow your career in a supportive and innovative environment. Enjoy endless opportunities for career advancement, a comprehensive rewards package, and various health and wellbeing benefits. Shape the future of healthcare and empower clinical advancements as a visionary leader in a leading multinational pharmaceutical company.,

Join Amgen's Mission to Serve Patients If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. What You Will Do The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area/product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles And Responsibilities - Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels. - Publication-related deliverables (manuscripts/abstracts/posters/Oral presentations, enhanced content). - Addressing Medical Information inquiries/issues. - Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including the use of digital and multi-channel approaches, as well as definition of impactful KPIs. - Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners. - Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s). - Assist in recruiting, onboarding, and training of staff members. - Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget. - Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues. - Foster Amgen culture and motivate high-performing and empowered staff. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications - Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy. - Masters degree with a minimum of 12 years of experience. - Bachelors degree with a minimum of 14 years of experience. - Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Must-Have Skills - MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered). - Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area. - An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products. - Experience in publication planning, publications guidelines, and transparency standards (e.g., ICMJE, current Good Publication Practice (GPP) Guidelines). - Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally. - Demonstrated track record of strategic execution in a matrix environment with limited supervision. - The ability to work in teams and interface in a dynamic environment across corporate functions. Preferred Skills - Knowledge of emerging technologies in medical communications (e.g., AI tools, omnichannel engagement platforms). - Strong computer and database skills, particularly with Microsoft Office products. Soft Skills - Strong verbal and written communication skills. - Ability to work effectively with global, virtual teams. - High degree of initiative and self-motivation. - Ability to manage multiple priorities successfully. - Collaborative mindset with a strong sense of accountability and ownership. - Ability to drive continuous improvement and adapt quickly in a fast-evolving environment. - Strong project management with the ability for self-direction. 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 for a career that defies imagination. Objects in your future are closer than they appear. Join us. EQUAL OPPORTUNITY STATEMENT 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.,

Job Tittle - R&D Clinical Trial Support Associate Location - Hyderabad About the job The Clinical Trial Support Associate (CTSA) plays a pivotal role in supporting the Clinical Operations Study Leader (COSL), Global Study Leader (GSL for EDCO) and the Clinical Operations Study Country Leader (COSCL) throughout the entire lifecycle of clinical studies. The CTSA is entrusted with managing a wide range of study, country, and site-level activities delegated by the COSL, GSL and COSCL, ensuring seamless execution and delivery of clinical trials. As the central point of oversight, the CTSA coordinates activities across all levels within a study, maintaining a comprehensive view of study progress. They collaborate closely with the COSL/GSL to prepare study-related plans and materials, escalate issues appropriately, identify study risks, develop contingency plans, and monitor the study plans adherence. Additionally, the CTSA supports the COSCL in managing country or site-specific tasks, ensuring compliance and smooth operations. The CTSA also assists in the overall management of budget tracking and invoice approval, working alongside the clinical study leader and the clinical study country leader. They liaise with site monitors as needed to ensure site-level study compliance, acting with critical thinking and a problem-solving mindset. The CTSA executes tasks with integrity, ensuring all activities are suitable for regulatory review. Other key stakeholders include the Clinical Trial Support Manage (CTSM), vendor managers and any other study team member. The COSL, GSL and the COSCL provide oversight of the CTSAs activities, depending on whether they pertain to study or country-level operations. Main responsibilities include: Ensure study and site communication and documentation tasks Facilitate site and study team communication by distributing protocol amendments and Investigator Brochure updates. Develop and disseminate study newsletters and mass site communications (newsletters, memos). Maintain documentation tasks including ICF tracking logs, Patient Data Report (PDR) distribution and tracking, equipment leasing coordination, insurance request management, site training tracking, and whos who list maintenance. Supports completion of all study documents with the various study team members Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required. Ensure Financial management tasks Process study, investigator and vendor payment requests, manage invoices, create and track purchase orders (POs), and report payment statuses to COSL/GSL/COSCL and site monitor. Set up CTMS at study, country, and site levels, create and maintain site accounts, manage system access and manage tool access requests, for phase 1 studies maintain CTMS updated if applicable Conduct IPC (In-Process Control) checks at study, country, and site levels, support inspection readiness. Strong written and verbal communication skills. English language skill: ability to exchange fluently write meeting minutes/ emails/ study documents, internal & external communications. E xperience in clinical operations and managing clinical studies is preferred. Readily adapt to new environment, technologies and processes (e.g. new digital tools) Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines Experience in clinical operations and managing clinical studies is preferred. About you E xperience in clinical operations and managing clinical studies is preferred. Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs. Proficiency in CTMS and financial management experience or ability to quickly learn new systems and processes. Education: Bachelors degree in life sciences, healthcare administration, or related field or equivalent experience Assist with audit/inspection preparation and contribute to elaborate proper responses to audit/inspections, and provide PAI (Pre-Approval Inspection) readiness admin support. Prepare CSR appendices, manage BIMO activities, Audit and inspection administrative activities. Support access management for any tool/system used for the clinical trial Monitor CTMS compliance, generate and distribute reports, and oversee system data quality. Ensure CTMS & Systems Administration tasks Track budgets at study, country, and site levels, ensuring accurate payment status reporting and effective vendor management in finance systems.

Job Tittle: R&D Clinical Trial Support Team Lead Location - Hyderabad About the job The CTSM Team leader is responsible to support the clinical study leadership to execute and deliver on our clinical studies. The CTSM Team Leader will oversee and support a team of Clinical Trial Support Managers (CTSM) assigned to studies, to ensure that the assigned deliverables are met. The CTSM Team Leader will be responsible for the direct line management of, and for ensuring the training, coaching, motivation, and development of the CTSMs to maximize their expertise knowledge, capabilities, performance, and overall utility while supporting the clinical studies. The CTSM Team Leader will report to the CSO Study Management Head (India)and functionally to the Clinical Trial Support Head. Main responsibilities include: Accountable to ensure the qualification, expertise, onboarding, support and training for the in their team. They will drive the success of the CTSMs in their project roles Provide individualized coaching, mentoring and performance management. Create and manage individual performance and development plans, conduct regular performance reviews and goal setting sessions with each CTSM. Promote a positive team culture by encouraging open communication, teamwork and recognition of team member achievements. Provide guidance and support for escalations from the CTSMs and provide them with guidance to problem solve. Foster peer-to-peer collaboration. Training and Development Organize and facilitate training sessions for their team of CTSMs. Build documentation to support onboarding, training, and team processes. Lead recruiting and hiring for any new team members. High level understanding of the projects and priorities within their assigned CTMS team. Provide oversight of these studies to ensure adequate resource planning and support for the CTSM team to ensure the timelines and milestones of the studies are achieved. Ensure synergy and consistency of processes and tasks among the CTSMs. Support ongoing process improvement activities and ensure processes are shared with all CTSMs. Implement best practices and share lessons learned among the CTSMs. Maintain close collaboration with other CTSM team leaders as well as the Clinical Trial Support Leads and Clinical Trial Support Head. There could be instances where the CTSM Team Leader may have to interact with the Study Teams or other members of Clinical Science and Operations. Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH. About you Experience - Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH. Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs. Demonstrated ability to work efficiently with clinical study leader within the same project, ability to collaborate with cross-functional team members and external partners using collaborative negotiation skills. Ability to anticipate potential issues, proactively identify ways to resolve/mitigate, timely escalate with appropriate action plans. Readily adapt to new environment, technologies and processes (e.g. new digital tools) Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines. Ability to work autonomously. Strong written and verbal communication skills. English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, internal & external communications. Organize, participate, and lead meetings with their direct report CTSMs, but also with CTSL and CTSH.

ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What Youll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What Youll Bring Bachelors degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Masters degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience.

The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles and Responsibilities Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content) Addressing Medical Information inquiries/issues Creation of payer-related content, timely support for compendia Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff WHAT WE EXPECT OF YOU We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy Master s degree with a minimum of 12 years of experience Bachelor s degree with a minimum of 14 years of experience Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Must-Have Skills MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms) Strong computer and database skills, particularly with Microsoft Office products Soft Skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction

The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles & Responsibilities: Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels. Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content). Addressing Medical Information inquiries/issues. Creation of payer-related content, timely support for compendia. Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs. Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members. Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget. Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff. Basic Qualifications and Experience: Advanced scientific degree: Doctorate degree & 2 years of Global Publication OR Medical Communications OR Medical Value and Access OR Medical Strategy Experience. Master s degree & 6 years OR Bachelor s degree & 8 years OR Associates degree & 10 years AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Functional Skills: Preferred Qualifications: MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines ) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills: Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms). Strong computer and database skills, particularly with Microsoft Office products Soft Skills: Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction

Career Category Medical Affairs Job Description Join Amgens Mission to Serve Patients If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. WHAT YOU WILL DO The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles and Responsibilities Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content) Addressing Medical Information inquiries/issues Creation of payer-related content, timely support for compendia Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff WHAT WE EXPECT OF YOU We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy Master s degree with a minimum of 12 years of experience Bachelor s degree with a minimum of 14 years of experience Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Must-Have Skills MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms) Strong computer and database skills, particularly with Microsoft Office products Soft Skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. https://careers. amgen. com Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .

Career Category Medical Affairs Job Description Job Title: Senior Manager, Scientific Communications Role GCF: L6a Location: Hyderabad, India Company: Amgen About Us: 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. Role Description: The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles & Responsibilities: Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels. Publication-related deliverables (manuscripts / abstracts / posters / Oral presentations, enhanced content). Addressing Medical Information inquiries/issues. Creation of payer-related content, timely support for compendia. Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including use of digital and multi-channel approaches, as well as definition of impactful KPIs. Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s) Assist in recruiting, onboarding, and training of staff members. Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget. Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues Foster Amgen culture and motivate high-performing and empowered staff. Basic Qualifications and Experience: Advanced scientific degree: Doctorate degree & 2 years of Global Publication OR Medical Communications OR Medical Value and Access OR Medical Strategy Experience. Master s degree & 6 years OR Bachelor s degree & 8 years OR Associates degree & 10 years AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Functional Skills: Preferred Qualifications: MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered) Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Experience in publication planning, publications guidelines and transparency standards (e. g. , ICMJE, current Good Publication Practice (GPP) Guidelines ) Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Preferred Skills: Knowledge of emerging technologies in medical communications (e. g. , AI tools, omnichannel engagement platforms). Strong computer and database skills, particularly with Microsoft Office products Soft Skills: Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Collaborative mindset with a strong sense of accountability and ownership Ability to drive continuous improvement and adapt quickly in a fast-evolving environment Strong project management with ability for self-direction .

About ProcDNA ProcDNA is a global consulting firm. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. Were a passionate team of 275+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you wont be stuck in a cubicle - youll be out in the open water, shaping the future with brilliant minds. At ProcDNA, innovation isnt just encouraged, its ingrained in our DNA. We are looking for a strategic and entrepreneurial Senior Sales & Business Development Lead to spearhead the expansion of our Clinical vertical in the US market. This is a high-impact, high-visibility role where you ll be responsible for building new client relationships within the pharmaceutical and life sciences industry, driving solution sales, and playing a foundational role in growing our clinical services footprint in the US. You will work closely with the senior leadership team to shape go-to-market strategies, develop commercial partnerships, and establish our brand as a trusted clinical solutions partner across the US. What We re Looking For: A strategic business development leader with a proven track record of winning new logos and driving revenue in the clinical or healthcare domain. Someone who understands the nuances of clinical trials, R&D, regulatory requirements, and pharma buying behaviour. A highly networked individual who can connect with senior decision-makers. A self-starter who thrives in unstructured, high-growth environments and can independently build a market from the ground up. Strong collaborator with experience working in cross-functional, global teams, especially across India and US time zones. What You ll Do: Establish and grow the Clinical vertical in the US by identifying, targeting, and acquiring new clients within pharma, biotech, and life sciences companies. Build and nurture strategic relationships with key stakeholders across Clinical Development, Clinical Operations, and Procurement functions. Lead end-to-end sales cycles from prospecting and qualifying to pitching, solutioning, negotiating, and closing.

The Assistant Manager Proposal Management (Translational & Clinical Research) role at Syngene International Ltd. in Bangalore, within the Commercial department, involves contributing to the creation and delivery of high-quality proposals within the Clinical Development Business Unit. Syngene, an innovation-focused organization, provides integrated scientific services to various industries globally, with a clientele including renowned companies such as Bristol-Myers Squibb, Baxter, and GSK. Key responsibilities of the role include taking complete responsibility for proposal quality, ensuring timely delivery to the business development team, collaborating with technical and business development teams for competitive pricing, and liaising with vendors for necessary information. The role also involves updating deal trackers, coordinating contractual agreements, and transitioning awarded deals to the project management team. Educational qualifications required for the position include an M.Tech/Master's degree in Clinical Research/Pharmacology/Biotechnology or Life Sciences, with an MBA being desirable. Technical skills should include knowledge and experience in Translational & Clinical Research services, proficiency in Microsoft Office applications, strong planning and multitasking abilities, excellent communication skills, and familiarity with pre-sales/proposal management functions. Candidates should possess 8-10 years of experience in Contract Research Organization/Clinical research, with prior experience in Presales/Proposal Management being advantageous. Behavioral skills required for the role include attention to detail, team management capabilities, and proactive teamwork. The successful candidate will also be responsible for adhering to environment, health, and safety (EHS) requirements and ensuring their team's compliance with EHS measures. Syngene International Ltd. is an Equal Opportunity Employer committed to providing a supportive and inclusive work environment for all employees.,

At Bayer we re visionaries, driven to solve the world s toughest challenges and striving for a world where ,Health for all, Hunger for none is no longer a dream, but a real possibility. We re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible . There are so many reasons to join us. If you re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there s only one choice. Sr Medical Advisor - Oncology POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with TLs. YOUR TASKS AND RESPONSIBILITIES : Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors Support and educate internal customers in compliance with the Country s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Senior Medical Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programmes of the Business units within portfolio (included local studies NIS, IIR). Identifies, initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, collaborative and customer focused. Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel Ever feel burnt out by bureaucracy? Us too. Thats why were changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https: / / www.bayer.com / enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us + 022-25311234

Medical Writing Ops Analyst (Power BI) 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 Subject matter expert in assigned solutions, understanding the capabilities of the system(s) or dashboard, underlying data, and reporting capabilities. May also train other analysts. Responds to customer support inquiries in a timely manner. Develops knowledge base for team reference. May assist with planning and implementation of system changes to support business shifts. May assist with system upgrades, migration activities or integrations of new systems. Assists with solution design for new modules/ functionality and may develop solutions independently. May be responsible for multiple systems, reports or dashboards at one time. Maintains systems, reports and dashboard based on business feedback or enhancement requests. Provides a review of changes to the business. Will lead the team through source system or IT related changes that impact downstream systems and reports. May lead development of new reports or dashboards based on business requirements. Ability to design complex data models with multiple tables and relationships. Strong understanding of source data and has skill set to create/maintain data flow. Ensures quality delivery by implementing testing and validation steps. May be assigned to projects with complex reporting requirements requiring visualizations across new systems. Strong collaboration with business on requirements and data discovery. Drives timelines and delivery with business stakeholders. Use agile development methodologies to quickly support business needs. May help the business with proof of concepts or strategize on how to visualize the data for business consumption. May lead process improvement initiatives and make recommendations about opportunities to streamline processes. May include recommendations through data flows or workflow tools. May act and perform duties of Business Application Owner or Module Owner Liaison Deliver prompt and efficient user support, investigating and resolving reported data discrepancies and issues. Address complex technical or data-related issues as required. Development and delivery of training efforts for internal and external customers. Develop and maintain training materials to ensure user understanding and proficiency. May lead trainings for Business Unit stakeholders and functional teams. Responds to Service Desk tickets routed to the department system queues. Consistently keep users and support tickets updated with troubleshooting details and ongoing research progress until a resolution is reached. Attends meetings as required, preparing necessary updates, and completing all assigned action items. Following up with appropriate Management and / or stakeholders as appropriate. Uses effective customer-oriented communication skills to respond within agreed upon timeframes, utilizing most appropriate method of communication based on urgency and type of information needed. Identifies issues for escalation and routes appropriately, exhibiting careful judgement in communicating issues. Exercises appropriate critical thinking / problem solving skills to identify and understand a problem, analyzes, and communicate impact, and brings to a timely resolution.

About the job Use Your Power for Purpose At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Organizational Relationship(s) including to whom the position reports to: Case Processing Team Lead Position Purpose Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer s products and to meet regulatory requirements. Primary Responsibilities Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness / listedness / labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative. Generate reports, ensuring adherence to regulatory compliance timelines. Determine appropriate case follow-up, requesting follow-up letters when appropriate. Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pfizer policies. Qualifications (i. e. , Preferred Education, Experience, Attributes) Minimum a bachelor s degree in healthcare professional qualification (ie, Pharmacy, Dentistry, Nursing etc). 1 3-years experience in pharmacovigilance/ related domains. Work Location Assignment: Hybrid Medical #LI-PFE

Supervisor, Investigator Payments - India, Chennai - Hybrid, Office-Based At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. INSERT ADVERT TEXT HERE Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans and related benefits such as life assurance so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. 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

Supervisor, Investigator Payments - India, Chennai - Hybrid, Office-Based 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 At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. INSERT ADVERT TEXT HERE Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans and related benefits such as life assurance so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. 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. 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

JD: Serve as the company s subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.) Mentor and develop PV team members to maintain a culture of continuous improvement and compliance Manage departmental budgets, staffing, and resourcing in line with organizational needs Qualifications: Advanced degree in Medicine or Pharmacy Minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry In-depth understanding of Local/global PV regulations and guidance Demonstrated experience in leadership roles with proven ability to build and scale PV systems. Strong analytical, strategic thinking, and communication skills. JOB FAMILY: Product Development LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Description Associate QA Engineer Job Summary: An Associate QA Engineer, a role focused on ensuring product quality, develops and executes test plans, identifies defects, and collaborates with development teams to improve product quality, often working under the guidance of senior engineers. Knowledge, Skills & Abilities: Knowledge of programming languages like python , Java. Knowledge of SQL, performance tuning and experience with Bigquery/Snowflake. Knowledge of Datamodels, GIT, Jenkins. Experience with Cloud platforms like GCP,ACW, Azure. Strong analytical and problem-solving skills with the ability to synthesize information, summarize issues and think creatively. Excellent communication skills and able to convey information clearly and concisely . Education and Work Experience: Graduation or any equivalent qualification from a reputed institution. 0-2 years of experience Overall aggregate of the Candidate should be above 60% with no history of Arrears. Job Description: Develop ETL Pipelines/Applications (Coding and Programming using SQL, Python, AWS, Snowflake, GCP, Azure) Testing and Debugging ETL code Documenting and Testing new Software Applications Researching, Investigating and fixing wide range of technical issues Collaborating with Senior leaders Proactively learning about new Technologies Problem solving in different data domain and creating solutions About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product based industry services and accelerators. Discover more at saama.com. Benefits: Relocation Support: Assistance provided to employees who need to relocate for work. Learning & Certifications: A dedicated budget to support continuous learning and professional growth for all full-time employees. Self-Learning: Employees can avail 5,000 per quarter for self-learning courses, with a maximum of 3 sessions per quarter. Professional Certifications: A reimbursement of up to $700 per year for professional certifications, with a limit of 2 certifications annually. Leave Policy: Employees are entitled to 15 earned leaves per year, along with an additional 12 leaves (sick leave or casual leave) for better work-life balance. Tax-Saving Options: Various benefits are available to help employees optimize tax savings, including: Meal vouchers for daily expenses. Contribution to the National Pension Scheme (NPS) for retirement savings. Voluntary Provident Fund (VPF) to enhance long-term financial security. Group Mediclaim Policy: Comprehensive health coverage for employees and their families. Employee, Spouse, and Children: Covered up to 5 lakhs. Parents & In-Laws: Covered up to 3 lakhs. Lean IN Initiative: A women-centric program designed to empower and support female employees in their leadership and professional development journey.

A highly motivated and analytical Pharma Competitive Intelligence professional to join our growing team. You will be responsible for delivering timely, accurate, and actionable insights to support strategic business decisions, managing competitor monitoring projects, and producing in-depth market and competitive landscape reports. The ideal candidate should demonstrate strong cross-functional collaboration, clear communication, and the ability to work independently in a fast-paced, global environment. This is a critical role requiring immediate impact and deep CI expertise, along with a forward-looking mindset to leverage AI tools that enhance research workflows, accelerate insight generation, and improve overall efficiency. Key Responsibilities: Independently develop and deliver in depth, comprehensive CI deliverables including periodic monitoring, indication-based pipeline landscapes, competitor asset profiles, market landscapes, key event trackers, competitor approval timelines, conference coverage, newsletters etc. Analyze and triangulate information from multiple secondary data sources and propriety databases such as TrialTrove, PharmaProjects, Cortellis, Evaluate, DRG, AlphaSense, and more to deliver holistic competitor profiles and landscape assessments Develop client- ready outputs (slides or documents) with the best suited data synthesis and convincing visualization to convey key messages while maintaining rigorous quality checks on insights and outputs to ensure data accuracy and relevance Manage multiple CI projects under tight timelines interfacing with global clientele and prioritize requests based on the criticality and client expectations and strategic priorities Leverage advanced tools and innovative methods, including AI to enhance data collection, accelerate analysis, and improve efficiency and impact of deliverables by thinking beyond traditional approaches Understand business context about key client assets and competitor dynamics to monitor KITs/KIQs, and develop meaningful insights and recommendations from diverse data sources What You Bring: Experience: 4-6 years experience in competitive intelligence in pharmaceutical or life sciences industry Functional Skills: In-depth understanding of global pharmaceutical markets across development stages early pipeline, pre-launch, and marketed products including clinical development processes, regulatory pathways, and commercial considerations Strong experience in working with pharmaceutical databases including (but not limited to) BioMed tracker, PharmaProjects, Trial trove, IQVIA, Cortellis, Evaluate, DRG, AlphaSense Past experience of contributing to projects in but not limited to market landscaping, product/asset profiling, competitor benchmarking, pipeline assessments, conference monitoring, and triangulating data from multiple sources Proficient in Microsoft Office tools (PowerPoint, Excel, Word); ability to create compelling, insightful, and client-ready deliverables presentations and reports Awareness of and curiosity about AI/ML tools and their potential applications in CI workflows Behavioral Skills: High learning agility and a proactive mindset Resilient and adaptable in a dynamic, fast-paced work environment Team player with leadership potential, willing to take ownership and contribute to collective success Strong collaboration and interpersonal skills and work independently within a global and multicultural team (both virtual and in-person) Effective communication and articulation skills, ability to convey complex insights in a structured and impactful manner Strategic thinking to connect dots across data sets with attention to detail Good organizational, time management and priority setting skills, and the flexibility to multi-task Preferred Qualifications: Educational Qualifications: PhD/Masters Degree in Life Sciences. MBA from reputed institutes.

Investigator Payment Associate - India, Chennai - Hybrid, Office-Based 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 an Investigator Payment Associate to join our diverse and dynamic team. As an Investigator Payment Associate at ICON, you will play a crucial role in facilitating investigator payments, ensuring compliance with regulations, and reviewing the financial aspects of clinical trials. What you will be doing: Processing investigator payments accurately and timely according to study protocols. Maintaining documentation and records related to investigator payments in compliance with regulatory requirements. Discussing with internal teams to resolve payment discrepancies and address inquiries from investigators. Assert the development and implementation of processes to streamline investigator payment procedures. Assisting in the preparation of financial reports and analysis related to investigator payments. Your profile: Bachelor s degree in finance, Accounting, or related field. 1-2 years of experience in finance or accounting roles, preferably in the pharmaceutical or clinical research industry. KNwledge of regulatory requirements related to investigator payments (e.g., Sunshine Act, FMV). Strong attention to detail and ability to work accurately in a fast-paced environment. Proficiency in Microsoft Excel and financial software (e.g., SAP, Oracle). Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. 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

Career Category Regulatory Job Description Career Category: Regulatory Job Description Let s do this. Let s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e. g. , Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of directly related experience OR Bachelor s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com .

Let s do this. Let s change the world. In this vital role you will maximise domain 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 for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and customers understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. Maintain accurate documentation of configurations, processes, and changes. 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 / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience. Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Good-to-Have Skills: Demonstrated expertise in a clinical domain area and related technology needs. Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Able to communicate technical or complex subject matters in business terms Jira Align experience. Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology. Knowledge of cloud platforms (AWS, Azure, GCP). 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.

Career Category Regulatory Job Description Career Category: Regulatory Job Description Let s do this. Let s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents; Conduct the formal review and approval of authored documents, following applicable standard operating procedures; With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications; Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group) May provide functional area input for Global Regulatory Plan and team goals May work with contract and freelance writers May participate in training and mentoring of junior medical writers May participate in departmental and cross-departmental initiatives, as appropriate. Generate document timelines, with team input Keep abreast of relevant professional information and technology What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of directly related experience OR Bachelor s degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Preferred Qualifications: Functional Skills: Proficiency with word processing and other Microsoft Office Programs Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds; Ability to understand and follow complex standard operating procedures (SOP s), guidance documents, and work instructions; Understanding and application of principles, concepts, theories and standards of scientific/technical field. Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance s and requirements. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results 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.

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Job Summary: Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases. Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Responsible for raise of device/combination product case related issues. Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products. Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness. May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable. Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor. Key Activities: Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Ensures compliance and timely reporting with device/combination product cases through query process. Contributes to the implementation of new intake-related systems, processes and procedures within the process. Supports an engaging culture. Ensures quality of PC, AE and OSF records. Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems. Implements Standard Operating Procedure requirements for device/combination product cases. Develops solutions to technical problems up to moderate complexity. Knowledge and Skills: Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). Familiarity with clinical development process. Demonstrating high case level productivity and quality. Attention to detail. Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Master s degree and 7 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 9 years of Drug Safety or Life Sciences experience. Education & Experience (Preferred): Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry. Bachelor s Degree in a health-care subject area or scientific field. Previous experience with a corporate intake system or safety database. Ability to successfully manage workload to strict timelines. Familiarity with basic project management tools. Demonstrated ability to consistently deliver on-time, and high-quality results. Ability to operate in a matrixed or team environment. Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). 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.

Select with space bar to view the full contents of the job information. Specialist Regulatory Affairs LCM - Strategic Growth Products Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Specialist Regulatory Affairs LCM - Strategic Growth Products ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM for Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars and Specialty Generics that would require significant technical inputs on CMC and Clinical side during post approval phase. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as well become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Notification of Change in Marketing Status, sunset clause exemptions where applicable Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Biosimilars (but may as well extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc. for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, however, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Proven Biosimilars regulatory experience for EU preferably Life cycle activities. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently Well versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines or/and complex CMC post approval changes. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. 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