Bristol-Myers Squibb Company

Senior Scientific Writer

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1120685
Required Education
Doctorate/PHD/MD
Position Type
Full time
Responsibilities:

1. 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.

2. Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.

3. Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.

4. 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.

5. Review and edit documents as required.

6. As required, coordinate writing of responses to Health Authority questions.

Education, Experience, Skills:

1. 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.