Bristol Myers Squibb Senior Scientific Writer in Princeton, New Jersey
Coordinate and author documents needed for regulatory submissions (eg, IBs, Phase 2/3 CSRs, briefing documents, CTD summary documents), ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and 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.
As required, coordinate writing of responses to Health Authority questions.
Education, Experience, Skills:
- PharmD/PhD/MD in a relevant scientific discipline, or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, and good understanding of requirements for regulatory submission documents. 2. Demonstrated strong writing skills as evidenced by authoring and managing the production of Investigator Brochures (IBs) and Phase 1/2 Clinical Study Reports (CSRs).3. Good understanding of the global pharmaceutical drug development process and requirements for authoring CSRs for regulatory submissions.4. Demonstrated ability to analyze and interprete clinical data from a broad range of therapeutic areas.5. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.6. Working knowledge of a document management system and basic knowledge of the document publishing process.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.