Associate Documentation Lead

Celgene, NJ, United States
Sep 18, 2020
Required Education
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary / Objective

The Associate Documentation Lead:
  • Provides strategic direction and effectively drives the development and implementation of regulatory documentation strategy to deliver key R&D business objectives, supports "speed to patient", and facilitates submissions and approvals in key defined markets within global commercial geographic footprint
  • Aligns with governance on prioritization and execution of documentation submission strategy

Position Responsibilities
  • Under the mentorship of a Principal Documentation Director or with limited supervision:
  • Lead document prototyping and preparation processes to ensure:

coordination and efficient use of messages between internal development plans, IND and NDA documentation, and

appropriate prioritization of critical versus non-critical path activities
  • Drive the development and manage the implementation of regulatory documentation strategy to meet time and quality performance goals for filing regulatory dossiers as planned by Development Teams
  • Coordinate documentation activities of multi-functional authors and reviewers from discovery, pharmaceutical development, clinical discovery, development and life-cycle management; and manage the document review process to maximize speed and quality on behalf of the assigned development team(s)
  • Ensure documentation strategy is integrated to support filings, approvals and/or other regulatory commitments in the intended key markets
  • Contribute to the development of effective documentation processes and standards; implement the processes to support goals of assigned development team(s) and ensure maintenance of PRI documentation standards
  • 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 any issue(s), particularly the ones with a potential to impact the dossier quality or timelines
  • In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions In conjunction with appropriate disciplines, identify and ensure management of external documentation support when required
  • Participate in project and/or functional leadership opportunities, such as project-wide advisory role in FDT; Align with GCR, GBS and Regulatory TA Heads on overall messages and deliverables

Degree Requirements

PhD/MD/PharmD or MS/BS with prior experience

Experience Requirements

PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 5 years in pharmaceutical regulatory documentation, or equivalent with thorough understanding of requirements for high-level summary documents (Module 2 of CTD)

Key Competency Requirements
  • Limited experience (ie,
  • Drives the development and management of a single regulatory submission at one time (IND, BLA/sBLA, NDAs/sNDA, MAAs/Type 2 variation) and associated health authority responses
  • Demonstrated strong writing skills as evidenced by good quality writing in 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
  • Analyze and interpret complex data from a broad range of scientific disciplines
  • 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 document publishing process

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.