Strategic Regulatory Writing Lead (NDA/MAA)

Daiichi Sankyo, Inc.; Basking Ridge (NJ); On-site; USD 158,000 - 237,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Writing to produce scientifically accurate clinical regulatory documents and support strategic study-level insights.

Collaboration across functions is required to meet aggressive timelines, including drafting CSRs, briefs, and regulatory sections for INDs/NDAs/MAAs. The role demands advanced knowledge of BLA/MAA submissions, regulatory requirements, and experience with document management systems, supporting global regulatory

Qualifications

• Bachelor's Degree required.
• Master's Degree or PhD in relevant science field preferred.
• 4+ years of experience as a medical writer with a graduate degree (Doctorate preferred) or 7+ years with a Bachelor's degree.
• Submission document writing experience required.

Responsibilities

• Write critical, complex clinical and clinical pharmacology documents for filings and submissions.
• Ensure key messages are clear and consistent across documents.
• Critically review documents for scientific accuracy and alignment with company position.

Skills

Regulatory writing

Medical writing

ICH guidelines

Document management systems

Education

Bachelor's degree

Master's degree or PhD in relevant science

Tools

Document management systems

Job description

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Writing to produce scientifically accurate clinical regulatory documents and support strategic study-level insights.

Collaboration across functions is required to meet aggressive timelines, including drafting CSRs, briefs, and regulatory sections for INDs/NDAs/MAAs. The role demands advanced knowledge of BLA/MAA submissions, regulatory requirements, and experience with document management systems, supporting global regulatory