Bristol-Myers Squibb Company

Principal Documentation Lead

Location
Princeton, NJ, United States
Posted
Jul 17, 2019
Ref
R1516806
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary

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