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Associate Director, Medical Writing

Employer
Daiichi Sankyo
Location
Remote by Design Home Office
Start date
Sep 27, 2022

View more

Discipline
Clinical, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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

  • Write critical, complex clinical documents (eg, pivotal Phase 3 study protocols and reports, NDA/BLA/MAA submission documents) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents; support the lead author (Director, Medical Writing) in the search of scientific literature to place study results in context with other relevant data
  • Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
  • Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
  • Participate in initiatives with Medical Writing Group in Japan and the EU to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.
  • Aid Director, Medical Writing in determining resource needs, proactively identify issues and solutions, and contribute to timelines and processes

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.

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Find Us
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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