Scientific Writer II – Manager Level

About the role

Bristol Myers Squibb is seeking a Scientific Writer II at manager level to lead the strategy, coordination and authoring of regulatory documents that support product submissions and approvals across key markets. The role bridges scientific, medical and regulatory inputs to produce clear, concise, and compliant documentation throughout the product lifecycle.

Key responsibilities

• Coordinate and author regulatory documents such as Investigator's Brochures, safety update reports, benefit‑risk evaluation reports, clinical study reports and protocols.
• Integrate scientific, medical and regulatory input from cross‑functional teams to ensure consistency and accuracy.
• Utilize advanced document development tools, including AI‑enhanced and structured‑content platforms, to improve efficiency and quality.
• Participate in document sub‑teams, manage timelines, and oversee the review process.
• Contribute to document strategy sessions covering messaging, flow, logic and consistency.
• Maintain and update document prototypes and shells in line with internal and external guidelines.

Required profile

• Experience in regulatory writing within the pharmaceutical or biotech industry.
• Strong understanding of clinical pharmacology, safety and clinical documentation requirements.
• Ability to collaborate with multidisciplinary teams and manage complex projects.
• Excellent written communication skills with attention to detail.

Required skills

What we offer

• Opportunities to work on innovative therapies that impact patient lives.
• Access to competitive benefits, flexible work arrangements and professional development programs.
• A collaborative environment with high‑performing teams across the globe.