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Associate Director Documentation Lead

Company: Bristol Myers Squibb
Location: Princeton
Posted on: April 10, 2021

Job Description:

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** + 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** + Act as Medical Writing submission lead, driving content and strategy of clinical documents. + 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** + Extensive experience writing clinical & regulatory documents and with registration dossiers for worldwide use + Expertise in MS WORD, including the ability to solve technical problems with WORD templates + Limited experience (ie,

Keywords: Bristol Myers Squibb, Trenton , Associate Director Documentation Lead, Executive , Princeton, New Jersey

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