Bristol Myers Squibb
Pharmaceutical
Manager,GlobalScientificandRegulatoryDocumentation
“Manager, Global Scientific and Regulatory Documentation at Bristol Myers Squibb. Skills: document strategy, authoring regulatory documents, regulatory submissions, cross-functional team collaboration. Coordinate and author regulatory documents [eg, Investigator's Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), and protocols]. Use document development tools that incorporate artificial intelligence, structured content, prog”
What You'll Achieve.
ensure the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members; ensure timely completion and high quality of assigned documents; facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline
Industry & Context.
resolve issues, errors, or inconsistencies
Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function for field-based and remote-by-design roles.
What They're Looking For.
Must Have
PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 2-4 years of regulatory documentation., Demonstrated writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR., Ability to analyze and interpret complex data from a broad range of scientific disciplines., Understanding of global pharmaceutical drug development., Demonstrated ability to manage timelines and quality of work using organizational, communication, facilitation, and interpersonal skills in a cross-functional team., Working knowledge of a document management system, basic knowledge of the document publishing process
What You'll Do.
Coordinate and author regulatory documents [eg
Investigator's Brochures (IB)
development safety update reports
periodic benefit-risk evaluation reports
clinical study reports (CSR)
Use document development tools that incorporate artificial intelligence
and other evolving approaches to enhance efficiency
and speed of processes.
Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions
and consistency for assigned projects.
Maintain document prototypes and shells.
Comply with internal and external processes and guidelines while managing the review process and
or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
How You'll Work.
Team & Collaboration
integration of the scientific, medical, and regulatory input from cross-functional team members; work with cross-functional team members; resolve issues, errors, or inconsistencies with pertinent team members
Communication Scope
communication skills
Process & Methodology
management of timelines for all components of assigned documents, manage timelines and quality of work
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