Manager, Medical Writing, Documentation QC
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Job Description
Manager overseeing Medical Writing Documentation QC, ensuring quality and compliance for regulatory documents at Acadia Pharmaceuticals. Collaborating with cross-functional teams to resolve issues and improve processes.
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
Requirements:
- 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
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
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