Regulatory Writing Associate Director
2 days 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. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory 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 and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) 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; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents.
- 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.
Education: (from an accredited college or university)
- 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.
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