Associate Director, Medical Writing

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

📋 Description

• Prepare specified clinical and regulatory documents from the planning phase and storyline development through to writing, review, approval, and final formatting.

• Create briefing books, cover letters, summary documents, investigator brochures, clinical study reports, protocols, and other development-related documentation.

• Align document preparation, review, approval, and production schedules with project management resources.

• Communicate and track deliverables, writing processes, and timelines with the Development team and management.

• Transform scientific and clinical data into documents that adhere to regulatory standards.

• Develop submission strategies and content outlines in collaboration with cross-functional team members and designate content partners.

• Act as the writing lead on assigned documents.

• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Rare Disease, Quality, and external entities.

• Ensure that electronic document deliverables are compiled in accordance with timelines, templates, and standards.

• Interpret source materials and clarify data based on scientific principles and regulatory standards.

• Verify document completeness, objectives, grammar, style, formatting, and compliance with ICH, regulations, guidelines, templates, and Acadia SOPs.

• Identify strategic solutions for writing-process challenges and escalate issues when necessary.

• Stay updated on Acadia and industry regulatory requirements.

• Provide guidance and oversight to contract writers and external vendors/agencies.

• Travel domestically and internationally as required.

⛳️ Requirements

• Master’s degree in a relevant field; a combination of education and experience may be acceptable.

• Aiming for 5 years of progressively responsible experience in science and medical writing, concentrating on clinical and regulatory document preparation, ideally in pharmaceutical or biotech settings.

• AMWA certification or another relevant certification, particularly in Pharmaceutical Writing, is highly preferred.

• Outstanding writing skills with the capability to translate scientific data into clear, scientifically accurate, and well-structured narratives.

• Competence in self-editing for readability, accuracy, consistency, and presentation.

• Knowledge of US, ICH, and international regulations, requirements, and guidance concerning scientific and clinical/regulatory documents and submissions.

• Familiarity and experience with Common Technical Document content templates and IND/NDA/MAA documentation expectations.

• Working knowledge of electronic document management and publishing systems.

• Ability to assimilate, interpret, and convey information/data to appropriate audiences.

• High proficiency in Windows word processing, flow diagrams, and spreadsheets.

• Capability to learn quickly and convert scientific data into high-quality summaries and reports.

• Flexibility to adapt documents as priorities, data, or strategies evolve.

• Compliance with applicable Acadia policies, procedures, and SOPs.

• Willingness and ability to travel domestically and internationally as required.

• Ability to occasionally lift and/or move up to 20 pounds.

• Capability to travel independently overnight and work after hours as necessitated by travel schedules or business needs.

🏝️ Benefits

• Competitive base salary, bonus, new hire and ongoing equity packages.

• Medical, dental, and vision insurance.

• Employer-paid life, disability, business travel, and EAP coverage.

• 401(k) Plan with a fully vested company match of 1:1 up to 5%.

• Employee Stock Purchase Plan with a 2-year purchase price lock-in.

• 15+ vacation days.

• 13-15 paid holidays, including office closure from December 24th to January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefit.

• Tuition assistance.

• Discretionary bonuses and equity awards based on individual and organizational performance.