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.
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
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Experience Qualifications
Travel
Ability to travel up to 10% In-house office position that may require travel (global).
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.
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