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 write, with minimal supervision of the lead author (Director, Medical Writing) complex documents including BLA/MAA submission documents (eg, Summary of Clinical Safety) and responses to HA requests for information. This position will contribute to strategy development for document authoring, and contribute strategically and scientifically at the study team level. The Associate Director, Medical Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).
Responsibilities
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Experience Qualifications
– 4 or More Years of experience as a medical writer with a graduate degree in a relevant science field preferred or
– 7 or More Years of experience as a medical writer with a Bachelor’s degree in a relevant science field preferred
– Regulatory Medical writing experience required
– Submission document writing experience preferred
Travel
Ability to travel up to 5% In-house/remote office position that may require domestic/global 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.
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