Medical Writing Director

Job Description

We're Hiring: Director, Medical Writing

We are seeking an accomplished Director, Medical Writing to provide strategic and operational leadership across medical writing activities, with a strong focus on Aggregate Safety Reporting (ASR) and pharmacovigilance deliverables.

This role will lead the planning, project management, scientific authoring, and delivery of complex safety and regulatory documents, ensuring scientific accuracy, regulatory compliance, and consistency across submissions. The ideal candidate will bring extensive experience in pharmaceutical or biotechnology environments, strong scientific judgment, and the ability to lead cross-functional teams and manage complex regulatory deliverables.

Key Responsibilities

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• Lead the planning, project management, and delivery of aggregate safety reports, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, and other pharmacovigilance deliverables.
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• Independently author, review, edit, and finalize complex safety and regulatory documents, including signal evaluation reports, benefit–risk assessments, safety topic assessments, health authority responses, and clinical safety summaries.
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• Develop document strategies, establish key scientific messages, and ensure consistent safety narratives across pharmacovigilance and regulatory deliverables.
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• Integrate and critically evaluate safety evidence from clinical trials, post-marketing sources, published literature, nonclinical studies, and other relevant data to support scientifically sound conclusions.
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• Translate complex clinical and safety findings into clear medical narratives, risk management measures, safety labeling, and regulatory recommendations.
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• Oversee multiple concurrent deliverables, establishing timelines, milestones, resource requirements, cross-functional reviews, and approval processes to ensure timely submission readiness.
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• Identify and proactively resolve project risks, content gaps, conflicting reviewer feedback, and potential bottlenecks while maintaining document quality and consistency.
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• Serve as a medical writing lead and strategic partner to Safety Physicians, Safety Scientists, Regulatory Affairs, Clinical Development, Biostatistics, and other cross-functional stakeholders.
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• Provide direction and oversight to internal medical writing teams, external partners, CROs, and vendors, ensuring high-quality deliverables and alignment with project objectives.
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• Support broader clinical and regulatory writing activities, including clinical study reports, investigator brochures, clinical trial protocols and amendments, health authority briefing packages, health authority responses, and CTD submission documents.
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• Drive continuous improvement initiatives by developing and maintaining SOPs, templates, guidance documents, authoring standards, and training materials.
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• Represent Medical Writing in cross-functional governance meetings, project teams, submission teams, and other strategic forums.
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Qualifications & Requirements

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• Advanced degree in Medicine, Pharmacy, Life Sciences, or a related scientific discipline (MD, PharmD, PhD, or equivalent).
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• Minimum of 10 years of relevant experience in pharmacovigilance, clinical safety, regulatory medical writing, or a related pharmaceutical/biotechnology field.
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• Extensive experience independently authoring and leading complex safety documents for marketing authorization and post-approval regulatory submissions.
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• Demonstrated expertise in aggregate safety reporting, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluations, and integrated safety assessments.
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• Strong understanding of global pharmacovigilance regulations, health authority expectations, CTD safety requirements, and regulatory submission processes.
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• Proven ability to synthesize complex clinical, safety, and scientific data into clear, balanced, and scientifically sound benefit–risk assessments.
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• Experience leading cross-functional medical writing activities, managing multiple deliverables, coordinating reviews, and ensuring compliance with regulatory timelines.
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• Demonstrated leadership experience providing strategic direction, mentoring medical writers, and overseeing external writing partners and vendors.
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• Excellent scientific writing, critical thinking, communication, stakeholder management, and organizational skills.
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• Experience developing medical writing strategies, processes, SOPs, templates, and quality standards.
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• Oncology development and regulatory submission experience is highly preferred , including familiarity with complex treatment settings, combination therapies, and safety assessments in patients with advanced disease.
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