Bristol-Myers Squibb Company

Lead, International Documents and Safety Reporting, I/O and Specialty

Princeton, NJ, US
Apr 12, 2018
Required Education
Position Type
Full time
Wallingford Transition

To manage the authoring of complex regulatory documents and support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by the BMS Development Teams.
1. Establishes strategic partnership with other functions within BMS to maintain fully integrated and standardized processes and systems, and a complete alignment of roles and responsibilities in order to meet BMS R&D objectives and priorities.
2. Establishes and maintains documentation standards, templates and best work practices that are consistent with internal and external guidelines for regulatory documentation; facilitates the development of innovative solutions to resolve issues.
3. Prepares criteria and strategies for the selection and maintenance of a pool of external resources to be used as needed.
4. Interfaces with Information Technology (IT) to provide business requirements for acquisition and maintenance of state of the art documentation tools.
1. Leads a group of scientific writers in producing high quality documents based upon good documentation principles within established optimum timelines.
2. Seeks talent from across the industry to help build a diverse, high performance group. Proactively and fluidly manages the group to take advantage of unplanned opportunities and overcome unforeseen obstacles, while achieving milestones.
3. Sets clear performance standards, provides feedback and coaching, identifies and fulfills training needs, and holds the group members accountable for key deliverables. Manages performance together with relevant project team leaders.
4. Coordinates employee development to build individual capability and understanding of organizational breadth and depth. Enables the group to proactively identify and take advantage of career development opportunities.
5. Assesses resource requirements for all projects, assigns resources according to BMS R&D priorities, and employs appropriate external documentation support for documents not covered adequately by in-house resources.
6. Reviews clinical documents (e.g. Investigator's Brochure, Phase 2/3 clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial IBs) for timely submission to health authorities worldwide according to:
• good documentation principles (organization, clarity, scientific standards)
• consistency between text and tabular presentations or graphical displays 13
• in compliance with BMS documentation standards and worldwide regulatory requirements
7. For projects without an assigned Documentation Lead,
• serves as a reviewer of project specific model documents and ensures maintenance of document prototypes/shell reports
• assesses resource requirements, assigns priority, and employs appropriate external documentation resources, if needed
• ensures that all documents authored by the group are consistent with target labeling objectives and support the project team's strategy to achieve timely approvals in key markets
• when using external resources, prepares specifications for the work and ensures maintenance of good documentation principles as well as BMS documentation standards
8. As required, coordinates writing of responses to health authority questions.
1. Influences other functions within BMS in matters pertaining to regulatory documentation processes and principles.
2. Facilitates proactive sharing of knowledge and key learnings within the group and across other functions.
3. Interfaces across multiple functions to mediate conflict resolution, and champions an organizational culture which promotes behaviors that lead to meaningful synergies and superior business performance.
1. Higher degree in a relevant scientific discipline with a minimum of 5 yrs of experience in regulatory documentation.
2. At least three major filings (NDA / MAA), preferably in different therapeutic areas.
3. Significant experience in writing high quality regulatory documentation, including high-level summary documents (preferably clinical).
4. Experience in developing and managing large groups.
5. Experience in working in a rapidly changing environment where decisiveness, adaptability and communication are critical to success.
6. Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
7. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
1. Assessed the requirements and provided tools, information and/or training to external documentation resources in order to produce document(s) that meet sponsor's documentation standards.
2. Strong capabilities in the areas of state of the art documentation processes and technology.