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.
Summary
The Documentation Lead for Full Development and International Submissions is responsible for providing strategic direction and effectively driving the development and implementation of regulatory documentation strategy to deliver key R&D business objectives, support “speed to patient”, and facilitate submissions and approvals in key defined markets within global commercial geographic footprint.
Aligning with governance on prioritization and execution of documentation submission strategy.
Position Requirements
PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 10 years in pharmaceutical regulatory documentation, or equivalent, and thorough understanding of requirements for high-level summary documents (Module 2 of CTD) Demonstrated leadership in developing and driving the regulatory documentation strategy and managing the regulatory clinical documentation supporting global submissions (BLA/NDA/MAA/Supplements) as well as associated post-submission activities Ability to drive the document development and management of multiple concurrent regulatory submissions (BLA/NDA/MAA/Supplements) and associated post‑submission activities Strong writing skills supporting pharmaceutical regulatory documentation and/or publications in peer-reviewed journals Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities Ability to analyze and interpret complex data from a broad range of scientific disciplines Strong project management and promotes quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team Ability to coach and mentor medical writers Working knowledge of a document management system and basic knowledge of document publishing process
Position Description
Leader of Submission-facing Documentation Strategy
Drive the development and manage the implementation of regulatory documentation strategy that support speed and quality performance goals for filing regulatory dossiers as planned by Development Teams
Align with Clinical, Statistics, and Regulatory leadership on overall messages and deliverables
Lead document prototyping and preparation of processes to ensure:
(i) coordination and efficient use of messages between internal development plans and externally submitted documentation (IND/CTA; marketing applications), and
(ii) appropriate prioritization of critical versus non-critical path activities
Lead the Global Scientific and Regulatory Documentation (GSRD) documentation team on planned submissions
Ensure documentation strategy is integrated to support filings, approvals, and/or other regulatory commitments in the intended key markets
Accountability for Planning and Preparation of Regulatory Documentation
Ensure all asset-facing clinical documentation within GSRD scope of deliverables is identified, resourced, and managed in time-appropriate manner
Coordinate documentation activities of multi-functional authors and reviewers from discovery, pharmaceutical development, clinical, and medical; manage the document review process to maximize speed and quality
Apply knowledge of internal and external guidance in providing feedback to Development Teams on issues related to regulatory documentation
Critically review project-specific model documents, key data texts and displays during dossier prototype creation, and facilitate reaching a consensus at key findings/final document review meeting
Influence the assigned Development Team(s) in tracking milestone activities and proactively identify opportunities and threats in terms of submission/documentation activities, and drives potential solutions with key team members
In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions for defined markets
In conjunction with appropriate functions, identify and ensure management of external documentation support when required
Champion of Quality and Shapes Culture
Contribute to the development of effective documentation processes and standards; in conjunction with cross-functional teams, implement to ensure compliance
Participate in project and/or functional leadership opportunities; assist with pressure testing submission timelines and processes at governance bodies
Champion the GSRD organization across multiple functions and identify meaningful synergies
Proactively share knowledge and key learnings within GSRD and within and across Development Teams
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.