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Procedural Document Manager

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: August 10, 2019

Job Description:

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 to support a GxP Quality Management System. - Review current 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 judgment to 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: Bachelors degree with 5-8 years experience, Masters degree with 3-5 years experience or PhD with 2-4 years experience working in a pharmaceutical or highly regulated environment. or - Associates 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.

Keywords: Bristol-Myers Squibb, New Brunswick , Procedural Document Manager, Executive , New Brunswick, New Jersey

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