Associate Director Regulatory Writing
4 weeks ago
The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines.
Responsibilities- Write critical, complex clinical and clinical pharmacology documents with minimal input from functional area experts; ensure key messages are clear and consistent within and across documents.
- 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.
- Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations, and drive changes as needed.
- Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Bachelor's Degree required.
- PhD in relevant science field preferred.
- Master's Degree in relevant science field preferred.
4 or More Years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field.
- 7 or More Years of experience as a medical writer with a bachelor's degree in a relevant science field.
- Submission document writing experience required.
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools, and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensure that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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