Bristol Myers Squibb Associate Director Medical Writing in Princeton, New Jersey
Coordinate and author complex documents needed for regulatory submissions (eg, pivotal Phase 3 CSRs, CTD summary documents, Risk Management Plans, Pediatric Investigational Plans, Advisory Committeee Brochures), 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.
Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Lead or co-lead (with Principal Documentation Director) teams to define content and organization for complex documents (eg CTD summary documents).
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. Mentor other members of the department as need arises.
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 thorough understanding of requirements for major regulatory submission documents.
Demonstrated strong writing skills as evidenced by authoring and managing the production of pivotal Phase 2/3 CSRs, briefing documents, and Common Technical Document (CTD) summary documents.
Thorough understanding of the global pharmaceutical drug development process and requirements for submission of regulatory dossiers to health authorities.
Demonstrated ability to analyze and interprete 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. 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.