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