Senior Regulatory Writing Leader (Remote-Option)

Daiichi Sankyo Co.; Basking Ridge (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Writing to lead the creation of high-quality regulatory documents (CSRs, NDA/MAA submissions, briefing books) and support strategic input for filings.

The role demands strong medical writing expertise, knowledge of regulatory requirements and ICH guidelines, with 4+ years (graduate degree) or 7+ years (Bachelor’s) in the field; travel up to 5%. Collaborating across clinical, regulatory, and submissions teams, you will drive timelines,

Qualifications

• Bachelor's degree in a relevant science field required.
• Master's degree or PhD preferred.
• 4+ years of medical writing with graduate degree or 7+ years with Bachelor's required.
• Experience writing submission documents (NDA/MAA/BLAs) required.

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

Skills

Regulatory writing

Medical writing

ICH guidance

Education

Bachelor's Degree

Master's Degree or PhD in relevant science field

Job description

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Writing to lead the creation of high-quality regulatory documents (CSRs, NDA/MAA submissions, briefing books) and support strategic input for filings.

The role demands strong medical writing expertise, knowledge of regulatory requirements and ICH guidelines, with 4+ years (graduate degree) or 7+ years (Bachelor’s) in the field; travel up to 5%. Collaborating across clinical, regulatory, and submissions teams, you will drive timelines,