Associate Director, Medical Writing

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we’re here to be their difference. Position Summary Join Acadia as an Associate Director, Medical Writing, and play a key role in advancing innovative therapies through the development of high-quality clinical and regulatory documents that support global product development and regulatory submissions. In this highly visible role, you will partner with cross-functional teams to transform complex scientific and clinical data into clear, compelling, and scientifically rigorous narratives for global health authorities.

From shaping document strategy to leading the development of critical submission materials, you will help drive programs forward while ensuring compliance with regulatory

Requirements

and industry standards. This is an exciting opportunity to contribute to impactful development programs while influencing the quality and success of regulatory communications. Primary

Works with all relevant team members to develop strategy and content outline for the submission, and to assign content partners for key sections of the document Serves as writing lead on assigned documents Communicates with internal and external groups (e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Rare Disease, and Quality) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents Ensures all clinical and regulatory electronic document deliverables are processed and compiled in alignment with timelines and relevant templates/standards Understands, assimilates, and interprets sources of information with appropriate guidance/direction from the Development team or other content experts Explains data in a manner consistent with scientific principles and regulatory

and with excellent diction, style and grammar Verifies completeness of information presented and ensures that the goals of the document are met Understands and complies with appropriate conventions, proper grammar usage, and correct format

per International Conference on Harmonization (ICH) and other governing bodies following applicable regulations, guidelines, templates, and Acadia SOP

Identifies and proposes creative and strategic solutions to resolve issues and questions arising during the writing process, including escalation as appropriate Maintains up-to-date compliance with all current Acadia and industry

as they relate to regulatory submissions by continually training and staying abreast of the l

Responsibilities

Implements activities related to the preparation of defined documents (from planning/story-line development to writing, to the facilitation of review and approval, and final formatting). Documents to be assigned may include briefing books, cover letters, summary documents, etc., as well as other development-related documentation such as investigator brochures, clinical study reports, and protocols Synchronizes, with appropriate project management resources, the timelines and process for preparation, review, approval, and other appropriate functions involved in the production of high-quality documents Communicates and tracks deliverables, writing process, and timelines to the Development team and to management, as appropriate Converts relevant data and information into documents consistent with all applicable regulatory