Senior Executive Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic oversight for the medical writing department.

• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Quality Assurance, Pharmacovigilance, and Executive Management.

• Lead the planning, creation, review, and distribution of clinical and regulatory documents.

• Set departmental goals, priorities, and performance metrics that align with corporate objectives.

• Act as the organization's authority in medical writing and functional leadership.

• Build, nurture, and retain a high-achieving medical writing team.

• Supervise external medical writing resources, vendors, and contract writers.

• Direct document strategy to ensure a consistent scientific narrative across programs and submissions.

• Oversee the development of clinical study protocols and amendments, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, IND/NDA/MAA submission components, clinical summaries and overviews, and responses to inquiries from health authorities.

• Work with cross-functional partners to synchronize document strategy, timelines, data interpretation, and key messaging.

• Influence decision-making and address complex issues through stakeholder engagement.

• Establish and uphold standards, processes, templates, and tools for document development.

• Ensure deliverables meet regulatory requirements, industry standards, company policies, and SOPs.

• Maintain inspection readiness and support compliance with GCP and relevant regulatory guidelines.

• Monitor changing regulatory expectations and industry best practices.

• Propel enhancements in the effectiveness, quality, and scalability of medical writing processes.

• Spearhead the implementation of new technologies, systems, structured content, automation, and AI-enabled solutions.

• Develop resource forecasts and allocate internal and external resources across programs and priorities.

⛳️ Requirements

• Advanced scientific degree (PhD, PharmD, MD, or equivalent).

• 15+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry, including leadership roles.

• 8+ years of progressive leadership experience managing medical writing teams and complex development programs.

• Proven success in leading substantial regulatory submissions, including INDs, NDAs, MAAs, and responses to health authority inquiries.

• Extensive experience in authoring, reviewing, or supervising clinical and regulatory documents, including protocols, Investigator's Brochures, Clinical Study Reports, clinical summaries, and regulatory briefing materials.

• Strong knowledge of drug development processes.

• Experience in oncology drug development is preferred.

• Proven capability to lead cross-functional teams, influence stakeholders, and manage competing priorities.

• Experience in managing internal teams as well as external medical writing vendors or contractors.

• Strong understanding of global regulatory requirements, ICH E6 (R3) GCP, and relevant ICH guidelines including E3, E8 (R1), and M11.

• Experience in establishing processes, standards, and operational improvements that enhance quality, efficiency, and scalability.

• Demonstrated ability to handle multiple priorities and achieve results in a dynamic, fast-paced environment.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• PTO.

• Paid holidays.