Associate Director, Global Scientific and Regulatory Documentation, Content Strategy
Bristol Myers Squibb
August 25, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Position Summary
- Coordinate and author complex regulatory documents for regulatory submissions, ensuring integration of scientific, medical, and regulatory input for assets in immunology and cardiovascular therapeutic areas.
- Implement regulatory documentation standards to support speed and consistency across full development/life cycle management assets and geographies.
Key Responsibilities
- Author complex clinical/regulatory documents for submissions (e.g., Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA briefing books, responses to Health Authority queries) according to good documentation principles, consistency between text/tables/figures, and applicable BMS/regulatory requirements.
- Participate in document subteams; plan and manage timelines for assigned document components.
- Contribute to document strategy (messaging, document flow, logic, and consistency).
- Prepare and maintain document prototypes/shells; lead/co-lead teams to define content and organization for complex documents (e.g., CTD summary documents).
- Manage review processes and resolve issues/errors/inconsistencies to ensure optimal cross-team communication and timely, high-quality deliverables.
- Review regulatory/clinical documentation for organization, clarity, scientific standards, TA/asset consistency, and regulatory/BMS compliance.
- Share knowledge and key learnings across functions.
- Lead and influence authors across disciplines without a reporting relationship.
Qualifications & Experience
- PharmD/PhD/MD in a relevant scientific discipline, or Master’s/Bachelor’s with ~10 years pharmaceutical regulatory documentation (PhD biological sciences and PharmD considered).
- Expert writing skills for clinical/regulatory documents for registrational submissions.
- Ability to analyze/interpret complex multidisciplinary data.
- Thorough understanding of global drug development documentation requirements.
- Strong organizational, communication, facilitation, and interpersonal skills; cross-functional timeline/quality management.
- Working knowledge of a document management system and document publishing process.
- Experience with state-of-the-art documentation processes and technology.
- Coordinate and author complex regulatory documents for regulatory submissions, ensuring integration of scientific, medical, and regulatory input for assets in immunology and cardiovascular therapeutic areas.
- Implement regulatory documentation standards to support speed and consistency across full development/life cycle management assets and geographies.
Key Responsibilities
- Author complex clinical/regulatory documents for submissions (e.g., Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA briefing books, responses to Health Authority queries) according to good documentation principles, consistency between text/tables/figures, and applicable BMS/regulatory requirements.
- Participate in document subteams; plan and manage timelines for assigned document components.
- Contribute to document strategy (messaging, document flow, logic, and consistency).
- Prepare and maintain document prototypes/shells; lead/co-lead teams to define content and organization for complex documents (e.g., CTD summary documents).
- Manage review processes and resolve issues/errors/inconsistencies to ensure optimal cross-team communication and timely, high-quality deliverables.
- Review regulatory/clinical documentation for organization, clarity, scientific standards, TA/asset consistency, and regulatory/BMS compliance.
- Share knowledge and key learnings across functions.
- Lead and influence authors across disciplines without a reporting relationship.
Qualifications & Experience
- PharmD/PhD/MD in a relevant scientific discipline, or Master’s/Bachelor’s with ~10 years pharmaceutical regulatory documentation (PhD biological sciences and PharmD considered).
- Expert writing skills for clinical/regulatory documents for registrational submissions.
- Ability to analyze/interpret complex multidisciplinary data.
- Thorough understanding of global drug development documentation requirements.
- Strong organizational, communication, facilitation, and interpersonal skills; cross-functional timeline/quality management.
- Working knowledge of a document management system and document publishing process.
- Experience with state-of-the-art documentation processes and technology.