Bristol Myers Squibb Associate Documentation Lead in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
To participate in 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.
Participates in the development of worldwide regulatory documentation strategy in support of the development team’s strategy to achieve target labeling objectives, timely approvals, and/or other regulatory commitments
Ensures documentation strategy is integrated to support filings, approvals and/or other regulatory commitments in the intended key markets
Applies knowledge of internal and external guidances in providing feedback to the assigned development team(s) on issues related to regulatory documentation.
- Assists Documentation Lead or other senior manager by managing the document prototyping and preparation processes to ensure
• coordination and efficient use of messages between internal development plans, IND and NDA documentation
• appropriate prioritization of critical versus non-critical path activities
Ensures effective planning and resourcing of all documentation activities required to produce high quality and consistent dossiers for submission to health authorities.
Coordinates documentation activities of multi-functional authors and reviewers from discovery, pharmaceutical development, clinical discovery, development and life-cycle management; and manages the document review process to maximize speed and quality on behalf of the assigned development team(s).
Contributes to the development of effective documentation processes and standards; implements the processes to support goals of assigned development team(s) and ensures maintenance of PRI documentation standards.
In conjunction with appropriate disciplines, identifies and ensures management of external documentation support when required.
In conjunction with appropriate disciplines, identifies, and arranges for documentation training needs for project authors.
Supports the core team members of the assigned team(s) in the development and management of key dossier messages and issues; ensures their appropriate integration into the documentation in a consistent way.
Critically reviews project-specific model documents, key data texts and displays during dossier prototype creation and facilitates reaching a consensus at key findings/ final document review meeting.
Influences the assigned development team(s) in tracking milestone activities and proactively identifies any issue(s), particularly the ones with a potential to impact the dossier quality or timelines.
In conjunction with the team members, manages and coordinates responses to dossier-related health authority questions.
Influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship
In conjunction with a Documentation Lead or other senior manager, mentors and trains members of dossier authoring team in documentation principles and processes; and ensures project/therapeutic area training for all documentation resources assigned to the project.
Proactively manages progress against the dossier plans, identifies opportunities and threats in terms of dossier documentation activities, and presents potential solutions developed in consultation with a Documentation Lead or other senior manager and other key team members.
As a co-lead or member within regulatory documentation team, proactively shares knowledge and key learnings within and across development teams.
MD/PhD/PharmD/MS or equivalent, with good understanding of scientific principles and hypothesis testing and at least 3-5 years of pharmaceutical regulatory documentation.
Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals.
Analyzed and interpreted 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.
Participation in at least one major filing (NDA / MAA).
Thorough understanding of requirements for high-level summary documents (Module 2 of CTD).
Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
Worked successfully in a cross-functional project team; ability to lead/facilitate discussions and decision-making with cross-functional team members.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.