EG-140 - Regulatory Affairs / Medical Writing
$170,880–$207,061 year
On-sitePrinceton, New Jersey, United States
Job Summary
Coordinate and author complex regulatory documents for regulatory submissions, including Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, and Investigator's Brochures. Ensure integration of scientific, medical, and regulatory input from development team members while adhering to good documentation principles and BMS standards. Lead or co-lead teams to define content and organization for complex documents, manage document subteam timelines, and facilitate proactive sharing of key learnings across functions. Review regulatory and clinical documentation to establish consistency and compliance worldwide, resolving errors or inconsistencies with pertinent team members.
Required Qualifications
- PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation
- All PhD in biological sciences and PharmD candidates are considered
- Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents
- Analyze and interpret complex data from a broad range of scientific disciplines
- Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions
- Demonstrated ability to manage timelines and quality of work using strong 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
- Experience in the areas of state-of-the-art documentation processes and technology
- Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents
- Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship
- Site-essential roles require 100% of shifts onsite at your assigned facility
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