Associate Director, Regulatory Medical Writing (Seattle, WA, Foster City, CA or Remote)
The Medical Writing department resides organizationally within Regulatory Documentation and Submissions at Gilead. The Medical Writing department works to advance the strategy and creation of high-quality documents to support efficient and successful regulatory submissions across all regions.
JOB OVERVIEW / SUMMARY
Prepares scientific/regulatory documentation to support regulatory submissions. This position will plan and oversee the authoring of protocols for the oncology therapeutic area. Direct experience in oncology and protocol authoring is highly preferred.
** Note:The location of this job can be Seattle, WA, Foster City, CA or Remote. **
- Serve as the department representative for protocols in the oncology therapeutic area, providing guidance to program lead writers and other writers and contractors supporting protocol development. Ensures appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements, and internal Gilead document standards, with adherence to timelines and team expectations
- Develops solutions for the optimal organization and presentation of information to achieve the submission objectives in accordance with requirements and guidance for clinical/regulatory documents, with minimal input
- Independently authors a wide variety of clinical/regulatory documents of all types and complexities, particularly protocols, and including CSRs, IBs, CTD summaries, PIPs, and regulatory responses.
- May serve as an effective filing lead for a large complex regulatory submission, which includes development and management of document timeline and resource planning for assigned projects
- Participates on multiple cross-functional teams (e.g., regulatory submission teams, regulatory project teams) and provides guidance on regulatory submission document strategies
- May represent Medical Writing on cross-functional initiatives/teams supporting key RDS or Regulatory Affairs objectives
- Participates in or may lead medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document processes.
- May manage or supervise direct reports and contractors to ensure the highest quality of medical writing and adherence to Gilead document standards. Appropriately delegates projects and initiatives to team and identifies potential conflict and proactively takes action to mitigate
- If not managing or supervising direct reports or contractors, coaches, trains, and provides guidance to less experienced writers or contractors. Leads or advises others on complex projects or problems with broad impact and reviews documents written by less experienced or contract medical writers
KNOWLEDGE & SKILLS
- Excellent verbal communication, technical writing, and project management skills
- Demonstrates success in the preparation of complex clinical/regulatory documents at the individual study report and submission level
- Expert knowledge of industry regulations, regulatory documentation requirements, and Gilead medical writing processes and standards
- Effectively facilitates communication with a variety of individuals, including team/functional leadership and members of senior management
- Provides leadership and has ability to influence, negotiate, and collaborate within a cross-functional team environment
- Facilitates issue resolution and collaborates with cross-functional teams through processes of moderate complexity given clear direction
- Medical writing subject matter expert for clinical/regulatory documents and submissions of medium to high complexity
- Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System
EDUCATION & EXPERIENCE
- BA/BS and 10+ years of relevant experience (less with advanced degree)
- Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 5+ years of direct experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions
- Direct experience in oncology and protocol authoring is highly preferred.
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