Associate Director, Medical Writing

Acadia Pharmaceuticals Inc.

Associate Director leading clinical and regulatory medical writing for Acadia Pharmaceuticals’ neurological and rare disease therapies. Shaping submission strategies and documents for global health authorities.

Posted 8/13/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $157,000 - $196,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical and regulatory document preparation, including the ability to convert scientific data into clear narratives while ensuring compliance with ICH and regulatory standards. Proficient in managing timelines and collaborating with cross-functional teams to produce high-quality documentation.

Highest-signal resume keywords

Clinical And Regulatory Document PreparationExceptional Writing SkillsKnowledge Of ICH And Regulatory RequirementsAMWA CertificationElectronic Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Scientific Data InterpretationDocument FormattingContent Outline DevelopmentSubmission Strategy DevelopmentSelf-Editing For ReadabilityCommon Technical Document KnowledgeIND/NDA/MAA DocumentationHigh Proficiency In Windows Word ProcessingFlow DiagramsSpreadsheets

Soft Skills

CollaborationFlexibilityCommunicationProblem-SolvingAttention To Detail

Tools & Technologies

Electronic Document Management SystemsPublishing Systems

Certifications & Qualifications

AMWA Certification

Industry Keywords

PharmaceuticalBiotechClinical DevelopmentRegulatory AffairsQuality AssuranceRare Disease

About the role

Key responsibilities & impact

Prepare defined clinical and regulatory documents from planning and storyline development through writing, review, approval, and final formatting
Produce briefing books, cover letters, summary documents, investigator brochures, clinical study reports, protocols, and other development documentation
Synchronize document preparation, review, approval, and production timelines with project management resources
Communicate and track deliverables, writing processes, and timelines with the Development team and management
Convert scientific and clinical data into documents meeting regulatory requirements
Develop submission strategy and content outlines with cross-functional team members and assign content partners
Serve as writing lead on assigned documents
Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Rare Disease, Quality, and external groups
Ensure electronic document deliverables are compiled according to timelines, templates, and standards
Interpret source information and explain data according to scientific principles and regulatory requirements
Verify document completeness, objectives, grammar, style, formatting, and compliance with ICH, regulations, guidelines, templates, and Acadia SOPs
Identify strategic solutions to writing-process issues and escalate when appropriate
Maintain current knowledge of Acadia and industry regulatory requirements
Guide and oversee contract writers and external vendors/agencies
Travel domestically and internationally as needed

Requirements

What you’ll need

Master’s degree in a related field; an equivalent combination of education and experience may be considered
Targeting 5 years’ progressively responsible experience in science and medical writing focused on clinical and regulatory document preparation, preferably in pharmaceutical or biotech environments
AMWA certification or another certification, with a specialty in Pharmaceutical Writing, strongly preferred
Exceptional writing skills and ability to convert scientific data into clear, scientifically sound, well-structured narratives
Ability to self-edit for readability, accuracy, consistency, and presentation
Knowledge of US, ICH, and international regulations, requirements, and guidance for scientific and clinical/regulatory documents and submissions
Knowledge 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 translate information/data for appropriate audiences
High proficiency with Windows word processing, flow diagrams, and spreadsheets
Ability to learn quickly and convert scientific data into high-quality summaries and reports
Flexibility to adjust documents as priorities, data, or strategy change
Compliance with applicable Acadia policies, procedures, and SOPs
Willingness and ability to travel domestically and internationally as needed
Ability to occasionally lift and/or move up to 20 pounds
Ability to travel independently overnight and work after hours as required by travel schedules or business needs

Benefits

Comp & perks

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
Discretionary bonus and equity awards based on individual and organizational performance