Director Medical Writing

Acadia Pharmaceuticals; United States; Remote; USD 184,000 - 231,000; Full time

Job summary

An established industry player is seeking a skilled Regulatory Writer to join their innovative team. This role focuses on preparing clinical and regulatory documents, ensuring that submissions meet global health authority standards. With a commitment to advancing neuroscience, the company offers a collaborative environment where your expertise will contribute to groundbreaking solutions in healthcare. If you possess exceptional writing skills and a deep understanding of regulatory requirements, this opportunity allows you to make a meaningful impact in the field of neuroscience.

Qualifications

• 10 years of experience in scientific and regulatory writing.
• Exceptional writing skills with the ability to translate data into clear narratives.

Responsibilities

• Manage preparation of clinical and regulatory documents.
• Coordinate with project management to ensure timelines are followed.
• Lead the writing process for assigned documents.

Skills

Scientific Writing

Regulatory Writing

Data Interpretation

Project Management

Microsoft Office

Education

Master’s Degree in a Related Field

PhD in a Related Field

Tools

Electronic Document Management Systems

Job description

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and other neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Position Summary

The role involves compiling and preparing clinical and regulatory documents, translating scientific data into clear, well-structured submissions for global health authorities, supporting product development and regulatory submissions.

Primary Responsibilities

1. Manage all activities related to the preparation of documents such as briefing books, investigator brochures, clinical study reports, and slide decks, from planning to final formatting.
2. Coordinate with project management to ensure timelines and review processes are followed.
3. Communicate deliverables, processes, and timelines to relevant teams and management.
4. Convert data into documents that meet regulatory standards.
5. Develop strategies and outlines for submissions, assigning content responsibilities.
6. Lead the writing process for assigned documents.
7. Provide expertise and strategic input for multiple projects across therapeutic areas.
8. Collaborate with internal and external teams to ensure timely and accurate document completion.
9. Ensure electronic document management aligns with timelines and standards.
10. Interpret and explain data clearly, ensuring completeness and strategic alignment.
11. Follow regulatory conventions, standards, and SOPs.
12. Propose creative solutions to writing challenges and stay updated on industry requirements.
13. Guide and oversee external writers and vendors as needed.
14. Promote innovation in medical writing processes.

Education and Experience

• Master’s degree in a related field; PhD preferred, with approximately 10 years of experience in scientific and regulatory writing.
• AMWA certification or similar is preferred, with expertise in pharmaceutical writing.
• Exceptional writing skills, ability to translate data into clear narratives.
• Knowledge of US, ICH, and international regulatory requirements and documentation templates.
• Proficiency with electronic document management and publishing systems.
• Strong interpretation skills and ability to adapt content for different audiences.
• Proficiency in Microsoft Office and related software.
• Ability to learn quickly, adapt to changing priorities, and collaborate effectively.

Physical Requirements

Standard office environment activities, with occasional lifting up to 20 pounds, and ability to travel as needed.

#LI-REMOTE #LI-SM1

Compensation and Benefits

Salary range: $184,400 — $230,500 USD. Including base salary, discretionary bonus, and equity awards based on performance and location.

EEO Statement

Acadia is committed to diversity and equal employment opportunities. We encourage candidates from all backgrounds to apply and provide accommodations for applicants with disabilities upon request.

For accommodations or inquiries, contact [e-mail].