(Office-based in Princeton, NJ)
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Our regulatory medical writing team is seeking a senior-level medical writer to join our Princeton-based team. Medical writers are highly valued at BMS and we are a very close-knit department.
The Senior Scientific Writer will:
Coordinate and author documents needed for regulatory submissions (e.g., IBs Investigator Brochures, Phase 2/3 CSRs Clinical Study Reports, 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 sub team(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.
Demonstrated strong writing skills as evidenced by authoring and managing the production of Investigator Brochures (IBs) and Phase 1/2 Clinical Study Reports (CSRs). [Experience with these two documents is a must!]
PharmD/PhD in a relevant scientific discipline with prior authoring of IBs, CSRs for regulatory submissions, or MS / BS with a minimum of 3 years (MS) to 5 years (BS) of same, in pharmaceutical regulatory documentation, and good understanding of requirements for regulatory submission documents.
Good understanding of the global pharmaceutical drug development process and requirements for authoring CSRs for regulatory submissions.
Demonstrated ability to analyze and interpret clinical data from a broad range of therapeutic areas.
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 and basic knowledge of the document publishing process.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability
If interested, please send your resume to the hiring manager directly (do not apply online at bms.com!) at: Karen.Moretti@bms.com