Protocol Review Committee PRC Coordinator

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.

Summary

The Clinical Development Center of Excellence (CoE) ensures scientific rigor and quality of clinical documents within Global Drug Development (GDD). A critical component of the CoE responsibilities is the oversight of the TA-aligned PRCs within GDD. As an integral member of the PRC team, the PRC Coordinator helps achieve these objectives through by managing the Therapeutic Area (TA) PRC Process and supporting clinical teams through the process steps. The Coordinator will help drive implementation of the PRC process, work collaboratively with key stakeholders to strive for the highest quality output and audit compliance documentation.

In addition the PRC Coordinator role will work with peers to standardize and continuously improve the PRC workflow as appropriate. The role will serve as a process expert supporting the Fusion/ Quality Management Systems Initiatives to help drive improvement activities aligned with the QMS programs. The PRC Coordinator role will also partner with Enterprise Operational Excellence to assist in driving execution of the Governance Model as well as support their continuous improvement efforts. The role will also be supporting other key enterprise projects as appropriate.

Key Responsibilities

Process owner for 1-2 TA specific PRC(s)

Facilitate each Asset Teams journey through PRC review to ensure team readiness, appropriate review, clear documentation of decisions/approvals and process efficiency

Manage projects related to the ongoing implementation and continuous improvement of the PRC process

In coordination with the CoE Head and partnering with BI&A, develop, refine and report outcome-based metrics for the PRCs

Manage other initiatives related to Quality and the Governance process

Help develop norms and standards, including best practices in meeting management and guidance for participants in processes, to be shared across GDD

Partner with QMS and governance to align with overall quality process strategy and execution

Use appropriate change management and communication principles

Desired Background, Knowledge and Experience

Advanced degree (MA, MS, MBA, PhD, etc.) and 5 years of biopharma industry experience

Strong project management experience in the biopharma industry; PMP certification is desirable

Strong oral and written communications skills, as well as strong analytical ability

Demonstrated ability to build relationships, influence, negotiate and drive organizational engagement

Ability to handle multiple concurrent projects in a dynamic and challenging environment

Flexibility to adapt to changing needs of the organization

Understanding of relevant opportunities, interdependencies and complex trade-offs

Ability to manage multiple stakeholders, competing priorities and navigate uncertainty across the matrix

Experience in process management, continuous improvement and leading matrix leadership teams a plus

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.

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com