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.

This is a highly visible medical writing leadership role supporting clinical development programs and global regulatory submissions. You will translate complex scientific and clinical data into clear, compelling, and scientifically rigorous documents. The role spans document strategy, planning, writing, review coordination, approval, and final submission readiness. You will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality, and other cross-functional teams. You will serve as the writing lead for assigned documents and help shape narratives that communicate the value and evidence behind development programs. The position also offers opportunities to guide external writers and vendors while influencing medical writing standards and processes. It is an ideal opportunity for an experienced scientific writer who thrives in a collaborative, fast-moving pharmaceutical or biotechnology environment.

Accountabilities:: 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.

Requirements:

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.

Benefits:

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 , including an annual office closure from December 24 through January 1.

10 days of paid sick time .

Paid parental leave.

Tuition assistance.

Opportunities to work collaboratively across clinical, regulatory, scientific, and development functions.

Supportive environment focused on professional development, inclusion, innovation, and continuous learning.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1