Associate Director RampD Lifecycle Management QMS Documentation and Activities

Profile

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.

Manage and lead team of procedural document (PD) managers, writing associates and PDHQ content managers to create and/or revise procedural documents in R&D and GPS. 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. This position will also be responsible for supporting Lifecycle Management related activities.

Responsibilities:


Lead a ( PD) team to solve complex problems, create deliverables and complete them in a timely manner
Synthesize feedback from subject matter experts/ PD teams to identify and resolve issues in order to accurately document current and future PDs
Effectively manage projects, escalate issues as necessary and identify/meet key milestones
Collaborate with appropriate Regulatory colleagues on changes to new or revised GXP/ICH Guidelines to manage the interpretation, communication, and implementation of applicable changes to clinical research
Work with limited guidance to manage the development of PDs for key procedures, seeks input as needed.
Assist in developing the vision and strategy for the QS&LM Department
Participate in goal and objective setting for the department and oversees progress towards meeting objectives
Lead and implement change initiatives to achieve continuous improvement in QS&LM p rocesses, including how PDs are managed, updated, and drives change in the organization
Identify and lead improvement efforts within the QS&LM group
Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies.
Identify and implement state-of-the-art business models and systems for PD management and continuous improvement
Interpret regulations or contact appropriate resources regarding regulat i ons and maintain an awareness of compl i ance i ssues
Recommend improvements to the PD management process on the bas i s of regu l atory needs, benchmarking, and opportunit i es for business process improvement
Work close l y with upper management to identify and work with key stakeholders to ensure that PDs are deve l oped in accordance with current practice and functional needs
Manage the PD Leads by providing guidance and d i rection on how to effectively develop PDs, meet goa l s and objectives and manage the Book of Work
Prepare presentations and other mater i als to effective l y represent the QS&LM department
Negotiate complex situat i ons w i thout direct author i ty
Lead department Lifecycle Management process optimization through cross functional teams as part of project Fusion to identify root causes of sub optimal process flow, identify gaps, help teams with process new or re-write phase.
Champions and drives Lifecycle Management activities to meet Health Authority commitment deadlines


Required Knowledge/Skills/Qualifications

Education/Experience/Knowledge:

PhD with 6-8 years' experience working in a pharmaceutical or highly regulated environment, Master's degree with 8-10 years' experience or Bachelor's degree with 10-12 years' experience.

Skills/Competencies:


Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
Demonstrated ability to drive organizational change while balancing priorities utilizing strong organizational skills
Exemplary leadership skills as demonstrated by the ability to manage individuals and teams towards meeting goals
Ability to drive consensus, drive performance and to lead strategically.
Demonstrated success in managing project, team effectiveness, facilitation and presentation skills
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 and ICH 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 teambuilding 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.

Company: Bristol-Myers Squibb

Req Number: R1522744_EN

Updated: 2020-03-10 00:00:00.000 UTC

Location: Princeton,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Sign Up Now - MiamiCrossing.com