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
- 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
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
PhD 7+ years of experience with a Graduate Degree (Doctorate preferred) in a relevant science or 9+ years of experience with a Bachelor’s degree in a relevant science preferred Bachelor's Degree required
- 7 or More Years Regulatory Medical writing experience required
- CTD submission preparation experience required
- Submission Lead experience required
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.
Non Disclosure Agreement (Intellectual Property Law)
Biologics License Applications (Bla)