Manager Medical Writing
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 24, 2023
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Job Description:
Join a Legacy of Innovation 110 Years and Counting!Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 100 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 15,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. Under the Group's 2025 Vision to become a
"Global Pharma Innovator with Competitive Advantage in Oncology,"
Daiichi Sankyo is primarily focused on providing novel therapies in
oncology, as well as other research areas centered around rare
diseases and immune disorders.SummaryUnder the supervision of the
Associate Director or Director, this position will be responsible
for the hands-on preparation of protocols, Investigator Brochures
(IBs), and Clinical Study Reports (CSRs). As a content expert, this
position must have a working knowledge of and experience in
document management systems, relevant therapeutic areas, regulatory
requirements, and other aspects of drug development (eg,
nonclinical, pharmacokinetics, biostatistics). Support for
compilation of appendices and narrative
support.ResponsibilitiesServes as primary author on a variety of
clinical documents (protocols, CSRs, investigator brochures), with
guidance as needed from MW management and functional area experts;
Understands clinical data and uses text, tables, and figures as
appropriate to accurately and effectively convey key
messagesOrganizes and leads cross-functional meetings to determine
timelines and processes for document developmentSupports Associate
Director/Director in management of outsourced activities, including
development of CSR safety narrativesParticipates in appropriate
development teams and internal strategy and operations
meetingsChecks electronically published CSRs for completeness
(including Section 16 appendices) and adherence to company's
electronic publishing standards before archivingParticipates in
development of medical writing processes and working standards;
Uses knowledge of document development best practices to
continuously improve medical writing SOPs, templates, and house
style guide10Qualifications: Successful candidates will be able to
meet the qualifications below with or without a reasonable
accommodation.Education Qualifications (from an accredited college
or university)Bachelor's Degree 5+ years of experience as a medical
writer with a Bachelor's degree in a relevant scientific field
requiredMaster's Degree 2+ years of experience as a medical writer
with a Graduate Degree in a relevant scientific field preferred
Experience Qualifications2 or more years experience with a Graduate
Degree, with Regulatory/Medical writing experience and submission
document experience required5 or more years experience with
Bachelor's degree, with Regulatory/Medical writing experience and
submission document experience preferredTravelAbility to travel up
to 5% Ability to travel up to 5%In-house/remote office position
that may require domestic travel.Daiichi Sankyo, Inc. is an equal
opportunity/affirmative action employer. Qualified applicants will
receive consideration for employment without regard to sex, gender
identity, sexual orientation, race, color, religion, national
origin, disability, protected veteran status, age, or any other
characteristic protected by law.
Keywords: Daiichi Sankyo, Inc., Newark , Manager Medical Writing, Executive , Basking Ridge, New Jersey
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