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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. 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.
The primary responsibilities of this position are to write critical, complex documents including BLA/MAA submission documents. This position will contribute to strategy development for document authoring, contribute strategically and scientifically at the project and/or study team level. This position may oversee internal and external writers with respect to document quality, and develop medical writing timelines, processes, and working standards. The Associate Director, Medical Writing will possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, and other aspects of drug development (e.g., nonclinical, pharmacokinetics, biostatistics).
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. Recommend data outputs for collection of specific data, propose document strategy for filings or responding to health authority requests); Proactively advise project and study teams regarding regulatory requirements and ICH guidance for clinical documents.
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; Ability to independently search scientific literature to place study results in context with other relevant data.
Oversee CROs and external writers with respect to document quality; Perform critical review of documents produced by junior/external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
Provide guidance to CROs and external writers on company standards and style and industry best practices for medical writing.
Determine resource needs, proactively identify issues and solutions, and set timelines and processes.
Develop medical writing timelines, processes, and working standards; Ensures company SOPs, templates, style guides, etc., are aligned with industry best practices.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Bachelor's Degree in a relevant science; Graduate Degree (Masters or Doctorate preferred) in a relevant science
Regulatory Medical writing experience required
5+ years of experience with a Graduate Degree
7+ years of experience with a Bachelor's Degree
Submission document writing experience highly desired
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.
Associate Director, Medical Writing
Regulatory Management Operations