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Senior Scientific Writer
Bristol Myers SquibbSenior Scientific Writer I at Bristol Myers Squibb, responsible for authoring complex clinical documents for China submissions. Collaborating in document strategy sessions and ensuring compliance with regulatory standards.
ATS Keywords
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Hard Skills
clinical document authoringCSR authoringbriefing document authoringCTD summary document authoringregulatory document reviewdocument editing
Soft Skills
leadershipinfluenceplanningmanagementcollaboration
Industry Keywords
BMS documentation standardsregulatory compliancehealth authority submissionsdocument strategytimelines management
About the role
Key responsibilities & impact- Author complex clinical documents needed for timely submission to China health authorities
- Ensure compliance with BMS documentation standards and worldwide regulatory requirements
- Participate in relevant document subteam(s) for planning and management
Requirements
What you’ll need- Author complex clinical documents (CSR, briefing documents, CTD summary documents, responses to Health Authority queries)
- Participate in document strategy sessions, ensuring effective planning and management of timelines
- Review and edit documents as required
- Lead and influence a diverse group of authors of regulatory documents from various disciplines.
Benefits
Comp & perks- Competitive benefits and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.