Career for M.Pharm, B.Pharm, M.Sc as Associate Medical Manager at Pfizer
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Associate Medical Manager - Medical Affairs
• Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-risk of Pfizer products
• Authoring documents that include support for major regulatory agency submissions, clinical overviews, health hazard assessments, listings and summaries of the results of the above research to the required standard
• Reviewing the produced documents for relevance and compliance under the guidance of medical manager
• GMPE support and reviewing therapy area sales training material for accuracy and alignment.
• Reviewing promotional material to ensure it is accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents
• Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products. Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews and clinical efficacy section in support of PBRERs, ACOs, PSURs, ARs, product renewals health hazard assessments, critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities
• Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
• Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues
• Clinical and scientific medical writing, editing, and quality control review (QC) for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures, and full submission documents for US and rest of world regulatory bodies.
• Pharmacovigilance and drug safety writing including: Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSUR), and Development Safety Update Reports (DSUR).
• Manuscript writing, including researching, organizing, compiling, interpreting, and quality checking various types of technical and/or medical information.
• Reviewing and editing of scientific reports: pharmacokinetics, pharmacodynamics, cardiovascular reports, etc.
• Medical communication writing including research and authoring of global medical standard response letters (“Dear Doctor” letters).
• Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.
• Communicating with different clients and their departments for a coordinated structure of functions and workflow.
• Adapting writing to different types of clients and audiences from the health care professionals and technical people to the consumer audience (general public).
• Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
• Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
• Understand relationships and dependencies between documents and analyses produced for regulators, e.g., RMP, DSUR, PBRER, and ACO.
• Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
Technical Skill Requirements
• Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
• Analytic skills. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
• Language skills. High fluency in written English and strong functional fluency in spoken English.
• Personal skills. Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• Interpersonal skills. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
• Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees 3 to 4 years relevant experience for medical graduates,PhDs masters in life sciences with atleast 3 years relevant experience for science graduates
Minimum 2 years of experience in medical writing, experience in using search tools, developing search strings, and assessing search results
• Experience in medical, scientific and regulatory writing.
• Conduct literature search and critical analysis to establish the safety and performance of the pharmaceutical agent and medical device. (analytic skills)
• Expertise in secondary research – experience in conducting specific search strategies and retrieving relevant articles from public domain. (technical / analytical skills)
• Uses tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. (technical skills)
• Prepares regulatory document such as PBRER, Addendum to Clinical Overview, efficacy summary report, etc. (technical experience)
• Conducts and interpret analyses and interpret routine medical and safety analyses without guidance from team members (analytic skills)
• Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge)
• Synthesizes analyses of medical and scientific data into clearly written text without supervision. (writing skills)
• Understands medical concepts of the disease and the specific approach to treatment. (medical knowledge)
Qualification : Ph.D, M.Pharm, M.Sc, B.Pharm, B.Sc
Experience : 2 years
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Affairs
End Date : 15th September, 2018
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