Associate Director, Medical Writing

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Acadia Pharmaceuticals Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1993

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $287.5M Post-IPO Equity on 2019-09

Healthcare • Pharmaceuticals • Biotechnology

Acadia Pharmaceuticals Inc. is a pharmaceutical company specializing in breakthroughs in neuroscience to enhance lives. For over 30 years, Acadia has been at the forefront of healthcare, pioneering treatments for conditions like Parkinson’s disease psychosis and Rett syndrome. The company's focus is on developing innovative and novel medicines that address unmet medical needs, especially in therapeutic areas with high demand, such as Prader-Willi syndrome, Alzheimer’s disease psychosis, and other central nervous system disorders. Acadia is dedicated to elevating life by embracing diverse perspectives, fostering collaboration, and advancing scientific research and development.

📋 Description

• 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

• 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

• 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