Bristol-Myers Squibb Company

Lead, Regulatory Client Engagement

Location
Tampa, FL, United States
Posted
Feb 25, 2019
Ref
R1513459_EN
Required Education
Masters Degree/MBA
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

Key Responsibilities and Major Duties

Strategic and Leadership:
  • Build Client Engagement Strategy aligned with BMS and RIM, Labeling strategies
  • Lead a cross-functional Matrix Team across regulatory, clinical and GPS functions to develop and execute strategies
  • Works with GRBC, IT partners and Regional Regulatory to ensure strategy is aligned with the wider organization
  • Core Member of BRIDG (RIM Governance Committee) and Labeling Office (Labeling Oversight Committee)


Business Support
  • Proactively monitors data quality and compliance and provides people and process related support and facilitates transformation to the new RIM and Labeling environment
  • Point of Contact for process related issues (technology issues are out of scope), assures appropriate use of services desk
  • Develop and align key performance indicators, metrics and milestones and proactively communicates to Senior Management and broader organization


Continuous Improvement:
  • Drives a culture of innovation through proactively identifying opportunities and areas of improvement
  • Responsible for identification and initiation of continuous improvement opportunities.


Change Management
  • Drives usage and adoption of RIM and Labeling processes by proactively monitoring data quality and initiating remediation with respective clients
  • Builds networks across the enterprise to ensure Best Practices are shared and insights from other regions / functions are leveraged
  • Acts as Business Change Agent for Implementation of Regulatory Information Management System and Labeling systems


Required:
  • Masters with 5+ years of relevant pharmaceutical industry experience with a minimum of 2 years of Regulatory experience
  • Strong knowledge and experience with regulatory systems
  • Strong understanding of Regulatory Operations and Labeling
  • Experience in Matrix environment and dealing with internal and external customers
  • Excellent interpersonal, written/verbal communication skills with all levels of management and staff in a multicultural environment
  • Excellent command of English language, both written and oral
  • Ability to lead a cross-functional Matrix team
  • Strong conflict resolution / problem solving skills
  • Ability to align and motivate a geographically disperse team
  • Ability to engage influence and leverage others
  • Ability to balance shifting priorities with ease and stay on track


Ideal Candidates Would Also Have:
  • Leadership experience 2+ years
  • Regulatory experience in a specific region, e.g. Europe, North America, Asia Pac


Other qualifications:
  • Ability to engage, influence and leverage others
  • Demonstrated ability to develop and mentor others
  • US military experience will be considered towards industry experience requirements