Bristol Myers Squibb Company

Documentation Lead, Early Development

Location
Lawrence Township, NJ, United States
Posted
Sep 05, 2020
Ref
R1524496
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as hematology, oncology, cardiovascular diseases, immunoscience, neuroscience and fibrosis. We believe that the diverse experiences and perspectives of our employees helps drive innovation and business results.

The Early Development Documentation Lead is responsible for authoring high quality message driven regulatory documentation, ensuring regulatory documentation standards are met, and leading regulatory documentation strategy to deliver high quality regulatory submissions for drugs in early development (Phases 1-2b clinical trials).

Position Requirements
  • PhD/MD/PharmD in a relevant scientific discipline or MS / BS with 3-5 years of experience in pharmaceutical regulatory documentation, or equivalent, and a thorough understanding of health authority summary documents.
  • Experience with authoring regulatory documentation and management of regulatory documentation strategy for regulatory submissions in early development (Phase 1-2b INDs, CTAs, FDA Type A, B and C Meetings, Scientific Advice, etc.,).
  • Strong writing skills and ability to analyze and interpret complex data from a broad range of scientific disciplines as evidenced by high quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals.
  • Good understanding of global pharmaceutical development and regulatory submission requirements including a working knowledge of document management and publishing systems.
  • Demonstrated ability to manage timelines and quality of work using strong organizational, communication, and interpersonal skills in a diverse cross-functional team.

Position Description
  • Leads authoring for a variety of regulatory documentation including briefing books, Module 2 summaries, and dossier-related health authority responses. These documents are developed by coordinating content from multiple subject matter experts representing a range of scientific disciplines including: nonclinical research and development, clinical research and development pharmaceutical development, regulatory, and worldwide safety.
  • Develops and manages regulatory documentation strategy to ensure development team objectives, timelines, and quality goals are met for regulatory submissions.
  • Manages the document review process to maximize speed and quality on behalf of the development team and proactively identifies issue, particularly those with a potential to impact dossier quality or submission timelines.
  • Contributes to the development of effective documentation processes, standards, model documents and other regulatory documentation tools. operational excellence of the department.


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.

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.