Senior Director, Medical Writing
Company: Arcus Biosciences
Location: Hayward
Posted on: January 20, 2023
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Job Description:
DescriptionSummaryThe Senior Director, Medical Writing will work
collaboratively with Arcus's regulatory, clinical and scientific
teams to produce high quality documents to support the company's
drug development programs. They will focus on the preparation of
regulatory and clinical documentation for submission to global
regulatory agencies and assist with the preparation of
publications, abstracts, and other external and internal
communications.--- They are responsible for developing and
implementing processes and standards to ensure company
documentation is prepared to the highest editorial standards and
quality. -ResponsibilitiesPrepare, edit, and finalize protocols,
investigator brochures, synopses, clinical study reports,
regulatory documents (INDs/NDAs, annual reports, Orphan Drug
Designation applications, Agency Response to Questions, briefing
books, etc.)Manage internal and external medical writers
-Collaborate with the clinical and scientific staff for narrative
and data presentation planning, gather material for relevant
documents and ensure that documents accurately reflect
sourcesManage the document review process and schedule and conduct
meetings to ensure documentation timelines are achievedPrepare
abstracts, posters, presentations, and manuscripts; assist in the
development and maintenance of quality and product
documentationAdvise and assist in the review and management of
nonclinical and CMC technical reportsDevelop and maintain Company
house-standard templates and best review practices for regulatory
and clinical documentation; ensure vendors and contractors maintain
company standard -Ensure documentation conforms to International
Conference on Harmonization (ICH) and other relevant regulatory
guidelines and medical editorial boards Ensure appropriate
documented quality control (QC) checks are performed and recommend
quality process improvementsEnsure documents are generated in
accordance with agreed internal processes and standards, are
submission ready, and are stored in appropriate document management
system(s)QualificationsBachelor's degree in medical-related field
or life science required; post-graduate degree (master's or
doctoral) -preferred8+ years of relevant medical writing experience
in the pharmaceutical industry, preferably in the therapeutic areas
of liver disease, oncology, or rare diseasesPrevious experience
managing direct reports is highly preferredThorough knowledge of
clinical research concepts, practices, and FDA regulations and ICH
Guidelines regarding drug development phases, clinical research and
medical writing standards; demonstrated ability to interpret and
apply these guidelines to document writing. -Demonstrated track
record of contribution to successful regulatory components used in
filings e.g., IND/CTAs, NDA/BLA/MAAs is important -Experience
interacting and communicating timeline expectations with cross
functional study team members -Experience with electronic document
management systems -Highly proficient in the functionality of MS
Word, Excel, Endnote, Adobe Acrobat, and PowerPoint -Familiarity
with statistical analysis concepts and techniques -preferredThis
role can be based at our Hayward, CA location (preferred) or can be
remote based. The anticipated salary range for fully qualified
candidates applying for this position is $225,000 - $285,000. For
remote-based candidates, the salary range may vary based on local
market data. Factors such as relevant experience, education,
duration of experience, and length of industry experience will
influence the actual salary offered. In addition to a competitive
market-based salary, Arcus offers the opportunity to participate in
stock programs, a performance-based bonus, and a comprehensive
benefits package. - Additional information about our total rewards
program can be found here: - .#LI-JC1Arcus Biosciences is an Equal
Opportunity Employer
Keywords: Arcus Biosciences, Hayward , Senior Director, Medical Writing, Healthcare , Hayward, California
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