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 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 requirements

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

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 requirements as they relate to regulatory submissions by continually training and staying abreast of the latest developments

Provides guidance and oversight to contract writers and external vendors/agencies when necessary

Other responsibilities as assigned

Education/Experience/Skills

Master’s degree in a related field; PhD preferred. An equivalent combination of education and experience may be considered

Targeting 5 years’ progressively responsible experience in science and medical writing with a focus on clinical and regulatory document preparation, preferably in a pharmaceutical or biotech environment. American Medical Writing Association (AMWA) certification or other is strongly preferred, with a specialty in Pharmaceutical Writing

Exceptional writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’

Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information

Knowledge of US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions

Knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation

Working knowledge of current electronic document management systems and publishing systems

Ability to assimilate, interpret and translate information/data for appropriate audiences

Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets

Ability to learn fast, grasp the 'essence' of a strategy or a story quickly to convert relevant scientific data/information into high-quality summaries and reports

Flexibility in the face of changing priorities and ability to change course, if needed, to improve or adjust a document when data or a new strategic direction suggests a need to do so

Creates a learning environment; open to feedback and suggestions and innovation for improvement

Embraces the ideas of others and cultivates a collaborative environment in order to complete assignments effectively

Ability to build and engage strong relationships, motivate and influence others, including those over whom they have no direct authority

Ensures compliance with all Acadia applicable policies, procedures and SOPs

Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-REMOTE #LI-RE1

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$157,000 — $196,500 USD

What we offer US-based Employees:

Competitive base, 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 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 between December 24th and January 1st

10 days of paid sick time

Paid parental leave benefit

Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women an