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Senior Director, Regulatory Writing

United States - California - Santa MonicaRegulatoryRegular

Arbeitsbeschreibung

We are seeking a Senior Director, Regulatory Writing who will serve as the lead writer for assigned programs and will be responsible for writing and delivery of clinical documents supporting INDs, BLAs, MAAs, and associated submissions. The incumbent will play a lead role on major regulatory filings and will supervise full time and contract writers as part of their core responsibilities. This role requires a results-oriented individual who excels in this fast-paced and dynamic immuno-oncology setting.

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Works independently, while ensuring appropriate and effective collaboration within Regulatory Writing and with key functional contributors

  • Oversees recruitment, and manages/supervises medical writers and contractors to ensure the highest quality of medical writing and adherence to Gilead document standards
  • Represents Medical Writing on cross-functional initiatives/teams supporting key company objectives
  • Acts as an advisor to R&D functional groups on the content and optimal presentation of clinical/regulatory documents to facilitate achievement of submission objectives in accordance with regulatory document requirements/guidance
  • May author complex clinical/regulatory documents
  • Ensures regulatory writing resourcing and delivery for business-critical projects

Leads regulatory writing submission teams

  • Preparation of clinical/regulatory documents, including CTD clinical summaries, for significant regulatory submissions and responses
  • As the subject matter expert, provides specialist medical writing expertise for clinical/regulatory documents
  • Typically leads at the therapy area level, overseeing strategic planning and leading cross-functional authoring teams through document preparation, review, and approval to deliver high-quality documents in accordance with required timelines; identifies key document messages and ensures inclusion of data supporting target labeling
  • Acts as primary contact for functional groups on requirements for clinical/regulatory documents and communicates new developments in this area
  • Assists with the development of cross-functional training programs with respect to regulatory requirements for clinical/regulatory documents and related processes
  • Leads or participates in medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document processes
  • Extensive experience with document management, authoring, and publishing tools, and their applicability for document workflow efficiency

Influences at the department level and cross-functionally to support complex objectives

  • Accomplishes results through others
  • Excellent medical writing, verbal communication, and project management skills
  • Converses with teams regarding resourcing or content for any medical writing deliverable at the therapy area level, and presents on matters such as document strategy, structures, and templates when working with cross-functional groups
  • Works proactively to avoid issues; facilitates issue resolution when necessary
  • Ensures training of cross-functional teams regarding standard regulatory writing processes
  • Extensive knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe
  • May lead highly complex companywide initiatives

Supports budgetary and resource projections within therapy area team and at department level

  • Oversees management of contract vendors by establishing and maintaining master service agreements, work orders, purchase orders, invoices, and vendor payments, and by ensuring appropriate onboarding, system access, and training

Minimum Requirements:

  • Advanced degree (i.e. MD, PharmD, PhD) and 12+ years’ clinical R&D, regulatory affairs, and/or academic research experience OR
  • Masters’ Degree and 12+ years’ relevant experience OR
  • Bachelors’ Degree and 14+ years’ relevant experience OR
  • High School Degree and 18+ years’ relevant experience
  • Prior headcount management experience required

Additional Qualifications

  • Advanced Degree highly desired
  • Experience in previous in-house role at sponsor company highly desired.
  • Ability to demonstrate writing aptitude through cited examples in the preparation of clinical/regulatory documents. This includes CTD clinical summaries for significant regulatory submissions and responses
  • Excellent verbal communication, writing, and project management skills
  • Knowledge of document management, authoring, and publishing tools, and their applicability for document workflow efficiency
  • Working knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe

Remote based applicants will be considered (some travel to Santa Monica required, once on-site work resumes)