Senior Specialist, Global Regulatory Processes And Training

Bristol Myers Squibb Princeton , NJ 08544

Posted 2 months ago

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 Responsibilities

  • Assign the employee training program on behalf of GRS

  • Supports GRS management and employees to manage compliance with Corporate training requirements including Compliance Metrics Reports

  • Support GRS training and Change Management logistics

  • Assign the onboarding program for new GRS employees; maintain a record of new GRS starters as provided by HR & GRS management

  • Work with R&D Learning Administrators to ensure assignment of appropriate role based training for the GxP activities/tasks undertaken by all GRS employees; work with Corporate Learning Administrators as required in the assignment of non-GxP Corporate training

  • Manage the GRS role based training assignments working with the GRS curricula owners; manage and assign the core GRS curriculum

  • Work with GRS Managers when roles are updated to ensure continued appropriate role based training assignments

  • Support GRP&T with internal audits and external regulatory authority inspections activities as required

  • Support GRP&T team in regulatory compliance projects as required

  • Support Status Reports / Metrics retrieved from QMS system

  • Support Change Management activities

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree Requirements

Bachelor's or Master's degree in lifesciences,

Experience Requirements

  • Minimum 3 yars experience as a training coordinator in the pharmaceutical industry and GxP training environment

  • Experience of Learning Management Systems (LMS) and experience or knowledge of electronic Document Management Systems (DMS)

  • Solid understanding of GxP requirements

  • Demonstrated knowledge and proficiency in Microsoft Office suite

  • Strong knowledge and demonstrated execution of continuous improvement and lean tools and techniques

  • Proven experience working in a matrix environment

  • Strong and demonstrated project management skills

Key Competency Requirements

  • Excellent written and verbal communication skills

  • Excellent and demonstrated time management skills

  • Global mindset - demonstrated strong interpersonal skills with peers and different levels of management

  • Positive attitude and solution-oriented approach

  • Demonstrates excellent judgment, performs with tact and professionalism

  • Handles confidential information with discretion

  • Stringent attention to detail and follow-up is critical

  • Possesses good problem solving skills and demonstrates diplomacy in dealing with difficult issues

  • Works effectively as a member of a team capable of prioritizing multiple tasks to meet project deadlines

  • Able to work effectively in an environment of changing priorities

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

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Senior Specialist, Global Regulatory Processes And Training

Bristol Myers Squibb