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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.
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.
ATS Keywords
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Hard Skills & Tools
clinical document authoringCSR authoringbriefing document authoringCTD summary document authoringregulatory document reviewdocument editing
Soft Skills
leadershipinfluenceplanningmanagementcollaboration