Scientific Documentation Lead
1 week ago
Bristol Myers Squibb offers a unique opportunity for Scientific Documentation Leads to join our team and contribute to the development of life-changing treatments.
About Us:
We are a pharmaceutical company dedicated to transforming patients' lives through innovative medicines and medical devices. Our mission is to deliver high-quality, safe, and effective products that improve healthcare outcomes worldwide.
Job Summary:
We seek an experienced Scientific Documentation Lead to coordinate and author complex regulatory documents needed for submissions to health authorities globally. The successful candidate will have a strong background in scientific writing, medical documentation, and regulatory affairs.
Key Responsibilities:
- Author complex clinical documents, including protocols, CSRs, CTD summary documents, Risk Management Plans, and responses to Health Authority queries, ensuring timely submission according to Good Documentation Principles and BMS documentation standards.
- Participate in document strategy sessions, develop document prototypes, and maintain document shells, ensuring consistency and quality.
- Coordinate with cross-functional teams, manage review processes, and resolve issues or inconsistencies.
- Review and edit documents as required, maintaining optimal communication between authoring teams and development teams.
- Serve as a liaison for external documentation support, prepare specifications, and ensure maintenance of good documentation principles and BMS documentation standards.
Qualifications & Experience:
- A PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation experience.
- Demonstrated strong writing skills, analysis, and interpretation of complex data from various scientific disciplines.
- Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
- Excellent organizational, communication, facilitation, and interpersonal skills in a cross-functional team environment.
- Working knowledge of document management systems and basic knowledge of the document publishing process.
Compensation: $135,000 - $160,000 per year, based on experience and qualifications.
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