Director, Scientific Regulatory Strategy and Scientific Writing--...
Pfizer, S.A. de C.V - Bothell, Washington, United States, 98021Work at Pfizer, S.A. de C.V
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Overview
Apply fast, check the full description by scrolling below to find out the full requirements for this role.Pfizer Oncology Research Unit colleagues play a key role in not only discovering new therapeutics but also in connecting our innovations including non-clinical scientific data and evidence with the Pfizer Oncology Development colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.POSITION SUMMARYReporting to the Head of Portfolio Strategy and Scientific Operations, you will be responsible for all Oncology regulatory submissions (e.g., IND, CTA, BLA, NDA, PIP, Annual Reports, IB updates) with significant impact on the business by providing strategic, scientific, and operational partnerships to the Research functions under our Oncology Research Unit (ORU).Within our ORU, you will work closely with Research Project Leaders (RPL), Research Project Managers (RPM) and engage with cross-functional teams to gain proficiency in the science behind the Pfizer pipeline to produce high-impact scientific communication materials.You and your team will partner with Research Project Leaders and the Research Project Teams to develop IND strategy for the non-clinical pharmacology sections during Lead Development stage preparing for IND submission post Candidate Selection (CS).You and your team will author the nonclinical pharmacology modules of all regulatory submission documents.KEY RESPONSIBILITIESIndependently author, edit, and revise technical and regulatory documents for submission to the FDA and other agencies with deep scientific understanding of scientific, technical, and experimental methods, results, and workflows.In collaboration with the Research Project Management function, will ensure each SRS team member develops project specific IND tracking tools for the project teams to facilitate the IND submission operational process.Ensure direct report(s) in your group timely complete regulatory submission documents at the expected quality level.Proactively anticipate problems and streamline workflows and process to avoid or minimize business impact with any regulatory submission delays.Serve as a member of decision-making bodies and be responsible for setting the long-range plans for their overall responsibilities together with the department executive.Regularly interact with senior management within and outside research to structure processes, timelines and work appropriately for team members and deliverables.Manage across all levels in the organization and when necessary, interface with governing committees outside of their function.Manage priorities and team that author and revise regulatory documents for submission to the FDA and other agencies, including the development of abstracts and presentations for medical congresses or scientific meetings and manuscripts for publication in peer-reviewed journals.MINIMUM REQUIREMENTSBachelor's Degree and 15+ years of regulatory submission experience in the biopharmaceutical industry ORMaster’s degree (MA/MS/MBA) and 13+ years of experience in the biopharmaceutical industry ORPhD/PharmD and 10+ years of regulatory submission experience in the biopharma industry.5+ years of people management experience, including experience including leading team members on challenging tasks and complex issues.In-depth knowledge of the drug discovery activities especially research and development experience for small molecules and biologics.Experience leading a small teamStrong written and oral communication skills.PREFERRED REQUIREMENTSClinical oncology drug development experience
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