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 our dynamic team as the Manager, Medical Writing Documentation QC! In this highly collaborative role, you will play a critical part in ensuring the quality, accuracy, and compliance of key Research & Development (R&D) documents, including protocols, clinical study reports (CSRs), Investigator’s Brochures, regulatory information amendments, and clinical summaries. Partnering closely with Medical Writing, Regulatory Affairs, and cross-functional R&D teams, you will identify and resolve content, source data, and formatting issues to support high-quality clinical and regulatory deliverables. This role also contributes to the continuous improvement of Medical Writing processes, tools, and operational excellence initiatives.

Primary Responsibilities

Performs QC checks on R&D documents while working in close partnership with members of R&D functions
Perform document QC review to ensure accuracy, consistency (including data, general legibility, consistency with style conventions), completeness of documents, etc., to ensure readiness for submission/finalization/publication
Perform document QC review for IND, NDA, and other submission types (e.g., CTA, MAA) and other regulatory, clinical, and safety documents as needed (e.g., protocols; CSRs; safety narratives; labeling updates; Investigator’s brochure updates; advisory committee materials)
Use established tools including QC error logs and source sheets to manage errors and document sources
Follow established SOPs and develop new procedures, as needed, to support document QC, retention, and management activities
Train new members of the QC Documentation team on QC practices for regulatory submission and other applicable types of documentation
Provide cross-functional support for Medical Writing, including support with CSR appendix deliverables
May assist with other Medical Writing initiatives, including process improvement, audits
Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in life sciences or related field. An equivalent combination of relevant education and experience may be considered
Targeting 5 years of progressively responsible experience in the regulatory document preparation/management arena
IND, CTA, NDA/MAA experience and understanding of regulatory principles for document development, QC, and archiving
Extensive quality control experience in the preparation, review, and finalization of regulatory submissions and supporting documents, including in support of an eCTD or other regulatory documents per ICH or other applicable standards
Experience in QC review of manuscripts, posters, abstracts, and slide decks preferred
Strong organizational, analytical, and technical writing skills, with high attention to detail and experience working in a fast-paced project team environment
Experience with authoring style guides, including providing input on making changes and improvements. Familiarity with formal styles such as AMA preferred
Advanced computer skills on Microsoft Office software (including Word, Excel, and PowerPoint)
Experience with document management/archival systems (e.g., VeevaVault, Livelink, SharePoint)
Must be willing and able to travel both domestically and internationally

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

$90,600—$113,200 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 and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.

Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.

Manager, Medical Writing Documentation QC

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