Manager, Medical Writing Documentation QC

About the role

Join our dynamic team as the Manager, Medical Writing Documentation QC!

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
• 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)

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.

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)

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.

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 strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

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.