Bristol Myers Squibb
SeniorScientificWriter
“Senior Scientific Writer at Bristol Myers Squibb. Skills: clinical documentation, regulatory submissions, medical writing. Author complex clinical documents. Ensure effective planning and management”
What You'll Achieve.
timely submission to China health authorities; timely completion and high quality of assigned documents
Industry & Context.
resolve issues, errors, or inconsistencies
On-site Protocol, Site-essential, Site-by-design, Field-based, Remote-by-design, travel to visit customers, patients or business partners, attend meetings on behalf of BMS
What They're Looking For.
Must Have
complex clinical documents, Clinical Study Reports, briefing documents, Common Technical Document, responses to Health Authority queries, good documentation principles, consistency between text and tabular, BMS documentation standards, worldwide regulatory requirements, document subteam(s), planning and management of timelines, document strategy sessions, messaging, document flow, logic, consistency, document prototyping sessions, document prototypes and shells, global regulatory submissions, Protocols, Phase 1/2/3, Investigator's Brochures, internal and external processes, guidelines, managing the review process, resolve issues, errors, or inconsistencies, optimal communication, coordination and efficient use of messages, internal development plans, IND, Marketing Authorization documentation, timely completion, high quality of assigned documents, Review and edit documents, liaison for external documentation support, prepare specifications, Lead and influence a diverse group, authors of regulatory documents, exploring innovative approaches and methods, medical writing
Nice to Have
innovative approaches and methods for medical writing
What You'll Do.
Author complex clinical documents
Ensure effective planning and management
Participate in document strategy sessions
Participate in document prototyping sessions
Comply with internal and external processes
Manage the review process
Review and edit documents
Serve as a liaison for external support
Lead and influence authors
Explore innovative approaches
How You'll Work.
Team & Collaboration
Participate in relevant document subteam(s); Ensure optimal communication between authoring team and development team members; Coordinate and efficient use of messages between internal development plans; Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship
Communication Scope
clarity; consistency; optimal communication; efficient use of messages
Process & Methodology
planning and management of timelines
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