Associate Director - Regulatory Documentation Strategy

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 171,000 - 207,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ is seeking an Associate Director, Global Scientific and Regulatory Documentation, Content Strategy to coordinate and author complex regulatory documents for submissions across immunology and cardiovascular assets. You will lead cross-functional teams to ensure consistency, quality, and timely delivery of CTD, CSRs, and related materials.

The role requires strong writing skills, experience with global regulatory submissions, and the ability to manage

Qualifications

• PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation.
• Demonstrated expert writing skills in authoring and managing the production of regulatory documents including registrational submissions.
• Analyze and interpret complex data from a broad range of scientific disciplines.
• Thorough understanding of global pharmaceutical drug development and documentation requirements.
• Demonstrated ability to manage timelines and quality of work in cross-functional teams.

Responsibilities

• Author complex clinical documents for regulatory submissions (eg, CTD, CSRs, Pediatric Plans) for timely submission to health authorities.
• Lead or co-lead document strategy sessions and define content and organization for complex documents.
• Coordinate review processes and ensure timely completion and high quality of assigned documents.

Skills

Regulatory writing

Project management

Cross-functional teamwork

Timeline management

Education

Advanced degree in life sciences

Tools

Document management system

Regulatory publishing software

Job description

Bristol Myers Squibb in Princeton, NJ is seeking an Associate Director, Global Scientific and Regulatory Documentation, Content Strategy to coordinate and author complex regulatory documents for submissions across immunology and cardiovascular assets. You will lead cross-functional teams to ensure consistency, quality, and timely delivery of CTD, CSRs, and related materials.

The role requires strong writing skills, experience with global regulatory submissions, and the ability to manage