Manager/Sr. Manager, Medical Writing

Location
Hayward, California
Posted
Jun 09, 2021
Ref
oqHoffwu
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Locations: Hayward, California | Brisbane, California | Remote, United States

Summary

The Manager/Sr. Manager, Medical Writing (MW) will prepare clinical/regulatory documents to support regulatory submissions and contribute to the development of internal Arcus MW processes. The Manager/Sr. Manager will plan and have oversight for medical writing deliverables for a wide variety of small-to-medium clinical/regulatory submissions from early-to-late phases of development.

Responsibilities

  • Independently prepare, edit, and finalize protocols including amendment, original and updated investigator brochures, synopses, clinical study reports (full and abbreviated), regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books)
  • Ensure appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements, internal Arcus document standards (utilizing the Arcus Manual of Style), and with adherence to timelines and team expectations.
  • May serve as a lead medical writer and department representative on medium-to-large development programs and represent MW on cross-functional initiatives/teams supporting key objectives
  • Participates in medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document or medical writing processes
  • Reviews documents written by less experienced or contract medical writers

Qualifications

  • BA/BS and 5+ years of relevant experience or post-graduate degree and 3+ years’ experience required
  • Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 4+ years of direct experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions; Medical writing experience in oncology or rare diseases desired
  • In-depth knowledge of industry regulations and regulatory documentation requirements
  • Shows leadership and autonomy and has ability to negotiate and collaborate within a cross‑functional team environment
  • Provides medical writing expertise for clinical/regulatory documents and submissions of low to medium complexity
  • Experience interacting and communicating timeline expectations with cross functional study team members
  • Highly proficient in the functionality of MS Word, Endnote, Adobe Acrobat, and PowerPoint
  • Experience with electronic document management systems
  • Familiarity with statistical analysis concepts and techniques preferred


Arcus Biosciences is an equal opportunity employer.