Director, Medical
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 24, 2021
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Job Description:
Director, Medical Writing in Basking Ridge, NJ at DSI Job
DescriptionJoin 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. In addition to a strong
portfolio of medicines for cardiovascular diseases, 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.
Job Summary:
The primary responsibilities of this position are to establish
strategies for document authoring, contribute strategically and
scientifically at the project and/or study team level, manage CROs
and external writers for document quality, and develop medical
writing timelines, processes, and working standards. The position
may independently serve as primary author of complex clinical
documents (e.g., pivotal Phase 3 protocols and reports) and lead
BLA/MAA submission document development. The Director, Medical
Writing will possess advanced knowledge of BLA/MAA submissions,
document management systems, relevant therapeutic areas, and other
aspects of drug development (e.g., nonclinical, pharmacokinetics,
biostatistics).
Responsibilities:
Provide leadership and establish strategies for document authoring
to projects/study teams at the organization level; Plan and
coordinate medical writing activities in collaboration with
stakeholders within and across regions. Critically review documents
produced by writers for scientific content and alignment with
company position, clarity, accuracy, and consistency
Contribute strategically and scientifically at the project and/or
study team level; Contribute to formation of key messages in
consultation with functional area experts (e.g. Recommending data
outputs for collection of specific data, proposing document
strategy for filings or responding to health authority requests);
Advise project and study teams regarding regulatory requirements
and ICH guidance for clinical documents
Determine resource needs based on workload and project priorities
and communicate in a timely fashion; Develop contingency plans to
address the business needs based on current therapeutic area
projects and anticipation of future therapeutic area projects
May write critical, complex clinical documents (e.g., pivotal Phase
3 protocols and reports, BLA/MAA submission documents) with minimal
input from functional area experts; Ensure key messages are clear
and consistent within and across documents; Able to independently
search scientific literature to place study results in context with
other relevant data
Represent Medical Writing on Global Medical Writing Committees;
Liaise with Medical Writing Group in Japan to identify Medical
Writing process improvement opportunities, potential collaborations
and drive changes as needed etc.
Sourcing Strategy and Management of Outsourced Medical Writing;
Provide strategic input on plans for outsourcing medical writing
and collaborate with Outsourcing and Legal on CRO/niche CROs
selection
Leads BLA /NDA/MAA submission writing strategy
Manage Medical Writers, assess performance, productivity, and
development
Qualifications: Successful candidates will be able to meet the
qualifications below with or without a reasonable
accommodation.
Education/Experience:
Bachelor's Degree in a relevant science; Graduate Degree (Masters
or Doctorate preferred) in a relevant science
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 Candidates with Disabilities Who Require Assistance
Daiichi Sankyo, Inc. provides reasonable accommodation in job
application procedures for qualified individuals with disabilities
and disabled veterans. If you have a disability that inhibits your
ability to apply for a position through our online application
process or you otherwise need accommodation in connection with the
recruiting process due to a disability, you may use the alternative
methods described below to contact us about your interest in
Daiichi Sankyo, Inc. and/or to request an accommodation. Daiichi
Sankyo, Inc.
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal
Opportunity Employment 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, Newark , Director, Medical, Executive , Basking Ridge, New Jersey
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