Clinical Pharmacology and Pharmacometric Documentation Strategy Lead

  • Company: Bristol-Myers Squibb
  • Location: Princeton, New Jersey
  • Posted: September 08, 2017
  • Reference ID: 1703357
Drives the development and management of clinical pharmmacology, biopharmaceutrics, and pharmacometrics-related regulatory documentation for BLA/sBLA, NDAs/sNDA, MAAs/Type 2 variation and associated health authority responses

Position Description :
Under the mentorship of a Principal Documentation Lead or with limited supervision:
1. Lead document prototyping and preparation processes to ensure:
(i) coordination and efficient use of messages between internal development plans, IND and NDA documentation, and
(ii) appropriate prioritization of critical versus non-critical path activities
2. 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
3. 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)
4. Ensure documentation strategy is integrated to support filings, approvals and/or other regulatory commitments in the intended key markets
5. 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
6. 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
7. 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
8. In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions
9. In conjunction with appropriate disciplines, identify and ensure management of external documentation support when required
10. 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

1. PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and thorough understanding of requirements for high-level summary documents (Module 2 of CTD)
2. Limited experience (ie, 3. 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
4. Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
5. Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
6. Analyze and interpret complex data from a broad range of scientific disciplines
7. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
8. Working knowledge of a document management system and basic knowledge of document publishing process

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