Senior Scientific Content Author
2 weeks ago
Transformative Work at Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science and innovation. Our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions.
Role Summary
We are seeking a highly skilled Sr. Scientific Content Author to coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of scientific, medical, and regulatory input from cross-functional team members.
Key Responsibilities
- Coordinate and author regulatory documents, such as Investigator's Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), protocols, and high-level summary documents.
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Maintain document prototypes and shells.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Review and edit documents as required.
Qualifications & Experience
We are looking for a candidate with a PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 2-4 years of regulatory documentation experience.
The ideal candidate will have demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR, as well as ability to analyze and interpret complex data from a broad range of scientific disciplines.
Understanding of global pharmaceutical drug development is also required, along with demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
Bristol Myers Squibb is an equal opportunities employer and welcomes applications from diverse candidates. Please note that this position is not a remote working opportunity.
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