Medical Writer Director

Location: Plainsboro, NJ 08536

Duration: 6+ MonthsRequirements:- Advanced degree in medicine, pharmacy, life sciences, or a related discipline (e.g., MD, PharmD, PhD), with a strong foundation in clinical research, medical science, and safety data interpretation.- Minimum 10 years of relevant experience in pharmacovigilance, clinical safety, regulatory medical writing, or a related pharmaceutical/biotechnology field, including substantial experience independently authoring complex safety documents and leading cross-functional authoring for major submissions.- Demonstrated experience leading safety authoring for complex marketing authorization and post-approval submissions, including document strategy, scientific content, review, and timely delivery.- Proven ability to independently author and critically review key safety and regulatory deliverables, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluations, health authority responses, Summaries of Clinical Safety, Clinical Overviews, Integrated Summaries of Safety, CSR safety sections, and patient narratives.- Demonstrated expertise in integrated safety assessments and benefit–risk evaluations, synthesizing clinical trial, post-marketing, literature, and other relevant evidence into scientifically sound conclusions and regulatory positions.- Experience translating safety findings into risk management measures, safety labeling, and health authority responses, while ensuring consistent scientific messaging across regulatory and pharmacovigilance deliverables.- Strong understanding of global health authority expectations, CTD safety content, and pharmacovigilance requirements, with experience supporting regulatory submissions and health authority interactions.- Strong scientific judgment and ability to interpret complex clinical and safety data, identify material findings and evidence gaps, reconcile conflicting evidence, communicate uncertainty, and develop clear, persuasive medical narratives and recommendations.- Proven ability to lead multiple concurrent deliverables and cross-functional reviews, manage dependencies and timelines, resolve content gaps, and maintain high standards for accuracy, traceability, consistency, and inspection readiness.- Excellent scientific writing, executive communication, and cross-functional leadership skills, with the ability to influence senior stakeholders and collaborate effectively across Safety, Regulatory Affairs, Clinical Development, Biostatistics, Medical Writing, and other relevant functions. Experience developing authoring standards, templates, SOPs, training, and process improvements is also expected.- Oncology development and submission experience preferred, including familiarity with complex treatment settings, combination therapies, and interpretation of safety findings in patients with advanced disease and significant comorbidities Expertly prepare (or oversee the work of others), edit, finalize and contribute to the strategic direction of complex clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health Authority briefing packages, Health Authority responses, and clinical CTD submission documentSupport in development, implementation, and execution of Medical Writing strategy in line with organizational strategyServe as compound lead writer and medical writing representative on cross-functional study teams and provide advanced knowledge and guidance on document strategy and content, timelines, and resource needs to ensure timely completion of tasks with desired quality

Responsibilities: The manager is looking to have someone start this assignment after the new year. He is open to having someone start in December if the timeline works out. REQ start date will be updated as needed.The Role:This role, Aggregate Safety Report (ASR) Project Management and Pharmacovigilance Medical Writer, leads the planning, project management, and scientific authoring of aggregate safety reports and other pharmacovigilance deliverables. It integrates and evaluates safety evidence to develop scientifically sound conclusions, ensures consistent safety messaging, and drives timely, high-quality, inspection-ready deliverables through cross-functional collaboration and continuous process improvement. Expertly prepare (or oversee the work of others), edit, finalize and contribute to the strategic direction of complex clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health Authority briefing packages, Health Authority responses, and clinical CTD submission documentSupport in development, implementation, and execution of Medical Writing strategy in line with organizational strategyServe as compound lead writer and medical writing representative on cross-functional study teams and provide advanced knowledge and guidance on document strategy and content, timelines, and resource needs to ensure timely completion of tasks with desired quality As required, oversee aspects of medical writing portfolio, including maintaining long-range forecast for Medical Writing needs Oversee medical writing activities and clearly establish expectations/responsibilities with partners/CROs/vendors Lead a submission team of Medical Writers providing vision, coaching, and oversight of deliverables Lead development and review of standard processes and templates for continuous process improvement and maintaining high quality and standards, and drive knowledge sharing sessions for cross-company initiatives Represent the Medical Writing team in forums (e.g. project boards, global development teams, operational committees, steering committees with partners, clinical management team, protocol review committee, regulatory submission teams).