Senior Regulatory Writing Lead (Remote)

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

Job summary

Daiichi Sankyo, a global healthcare leader, seeks an Associate Director, Regulatory Writing to produce high-quality regulatory documents and meet strict timelines. This role collaborates across functions and focuses on BLA/MAA submissions, CSRs, and briefing books while managing information flow and strategy.

The candidate will contribute scientific insights, oversee complex documents, and guide study teams on regulatory expectations, ICH guidelines, and filing readiness within a dynamic

Qualifications

• 4+ years of medical writing with graduate degree (Doctorate preferred) in relevant science field
• 7+ years of medical writing with a Bachelor's degree in relevant science field
• Submission document writing experience 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 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 at the study team level including recommendations for data outputs and support authoring documents for filings or responses to health authority requests
• Advise study teams on regulatory requirements and ICH guidance for clinical documents
• Participate in Global Regulatory Writing Group initiatives to identify improvements and drive changes
• Assess resource needs, identify issues and propose solutions, help develop timelines and processes

Skills

Medical writing

Regulatory writing

Clinical documentation

IND/NDA/MAA submissions

Regulatory strategy

Education

Bachelor's degree

Master's/PhD preferred

Job description

Daiichi Sankyo, a global healthcare leader, seeks an Associate Director, Regulatory Writing to produce high-quality regulatory documents and meet strict timelines. This role collaborates across functions and focuses on BLA/MAA submissions, CSRs, and briefing books while managing information flow and strategy.

The candidate will contribute scientific insights, oversee complex documents, and guide study teams on regulatory expectations, ICH guidelines, and filing readiness within a dynamic