Procedural Document Manager

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Develop and/or revise procedural documents in R&D and GPS to support the business unit processes. Procedural management activities include, but are not limited to, working with subject-matter experts to ensure accurate document content and compliance with health authority regulations and expectations.

Position Responsibilities

• Develop procedural documents tosupport a GxP Quality Management System.
• Reviewcurrent procedural documents with a compliance/regulatory mindset to identify key gaps and risks that SME teams need to remedy during the writing process.
• Synthesize feedback from subject matter experts/ PD teams to identify and resolve issues in order to accurately document current and future PDs.
• Proactively uses judgmentto manage risk and uncertainty, and to anticipate the need for and implement contingency plans.
• Effectively manage projects, escalate issues as necessary and identify/meet key milestones.
• Work with limited guidance to manage the development of PDs for key procedures, seeks input as needed.
• Team leadership skills that contribute to meeting team goals and resolving complex issues.
• Ability to think about solving problems through other mechanisms besides procedural documents.
• Maintain a good understanding of FDA regulations and ICH Guidelines and other guidelines applicable to GxP. Regulations and guidelines include but are not limited to:
• 21 CRF Parts 11, 58, 111, 210, 211, 610 and 820
• ICH E6, Q7, Q8, Q9, and Q10
• Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies.
• Negotiate and influence solutions without direct authority.

Experience Desired

• Preferred: Bachelor's degree with 5-8 years' experience, Master's degree with 3-5 years' experience or PhD with 2-4 years' experience working in a pharmaceutical or highly regulated environment. or
• Associate's degree or equivalent with at least 15 years' experience working in a pharmaceutical or highly regulated environment.

Other Qualifications

• Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
• Ability to drive consensus, drive performance and to lead strategically.
• Demonstrated knowledge of FDA regulations and ICH guidelines applicable to GXP. FDA regulations and ICH guidelines include, but are not limited to, the following:
  • 21 CRF Parts 11, 58, 111, 210, 211, 610 and 820
  • ICH E6, Q7, Q8, Q9, and Q10
• High level of competency in PD writing including the appropriate use of grammar, syntax and organization of ideas
• Knowledge of project management concepts and strategies
• Knowledge of requirements for development, use and maintenance of controlled procedural documents
• Demonstrated ability to resolve complex issues and differences in a creative, constructive and diplomatic manner
• Demonstrated ability to work independently and mentor team members
• Demonstrated ability to maintain a high level of productivity, accountability and energy
• Proven team building skills and an ability to foster partnerships across projects and multidisciplinary teams
• Demonstrated ability to follow up on open issues and drive results to completion
• Demonstrated ability to effectively and decisively establish appropriate priorities for self and matrix teams
• Proven track record for taking on challenges that are outside of normal book of work
• Strong communication skills

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.