Associate Director, Medical Writing

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Medical Writing based in the United States.

• Lead the end-to-end development of assigned clinical and regulatory documents, from planning and storyline development through writing, review, approval, formatting, and finalization.
• Serve as the primary medical writing lead for assigned documents, which may include briefing books, cover letters, summary documents, investigator brochures, clinical study reports, protocols, and other development materials.
• Partner with project management and cross-functional stakeholders to establish timelines, coordinate reviews, track deliverables, and ensure high-quality documents are delivered on schedule.
• Develop document strategies and content outlines with relevant subject-matter experts, assigning content ownership for key sections and coordinating contributions across teams.
• Translate complex scientific and clinical information into accurate, well-structured narratives that meet regulatory expectations and effectively communicate the objectives and evidence of each document.
• Ensure documents comply with applicable US, ICH, and international regulations, guidelines, templates, standards, and internal SOPs.
• Review source information for completeness, consistency, accuracy, and scientific integrity, ensuring each document fulfills its intended purpose.
• Coordinate the processing, compilation, and preparation of electronic clinical and regulatory documents in accordance with established standards and submission timelines.
• Identify potential challenges in the writing and review process, recommend practical solutions, and escalate issues appropriately when needed.
• Monitor evolving regulatory requirements and industry standards and maintain current knowledge through ongoing training and professional development.
• Provide guidance and oversight to contract medical writers, external vendors, and agencies when required.
• Build strong working relationships across functions and influence stakeholders effectively without direct authority to ensure timely and successful document completion.

• Master’s degree in a relevant scientific or related discipline; a PhD is preferred. Equivalent combinations of education and relevant professional experience may also be considered.
• Approximately 5 years of progressively responsible experience in medical writing and scientific communications, with a focus on clinical and regulatory documentation, preferably within a pharmaceutical or biotechnology environment.
• Exceptional scientific and medical writing skills, with demonstrated ability to transform complex data into clear, coherent, scientifically sound, and persuasive narratives.
• Strong self-editing capabilities, with meticulous attention to readability, accuracy, consistency, grammar, formatting, and presentation.
• Solid knowledge of US, ICH, and international regulatory requirements and guidance governing clinical and regulatory document preparation and submissions.
• Experience with Common Technical Document content and an understanding of documentation requirements for IND, NDA, MAA, and related regulatory submissions.
• Working knowledge of electronic document management and publishing systems.
• Ability to rapidly assimilate, interpret, and translate scientific and clinical information for diverse audiences.
• High proficiency with standard Windows-based productivity tools, particularly word processing, spreadsheets, and flow-diagram applications.
• Strong organizational and project coordination skills, with the flexibility to manage shifting priorities and adapt documents as data or development strategy evolves.
• Excellent verbal and written communication skills, with the ability to build relationships, motivate stakeholders, and influence contributors without direct reporting authority.
• Collaborative mindset, openness to feedback, and willingness to contribute to a learning-oriented and innovative team environment.
• AMWA certification or another relevant medical writing credential, particularly with a pharmaceutical writing specialization, is strongly preferred.
• Willingness and ability to travel domestically and internationally when business needs require it.

• Competitive base salary of $157,000–$196,500 USD, depending on experience, performance, and location.
• Eligibility for a discretionary annual bonus and equity awards.
• Competitive base compensation plus new-hire and ongoing equity opportunities.
• Medical, dental, and vision insurance.
• Employer-paid life insurance, disability coverage, business travel insurance, and Employee Assistance Program (EAP) coverage.
• 401(k) plan with a fully vested 1:1 employer match up to 5%.
• Employee Stock Purchase Plan with a two-year purchase price lock-in.
• 15+ vacation days and 13–15 paid holidays.