Bristol Myers Squibb Company

Business Operations Lead, Regulatory Strategy & Policy

Location
Summit East, NJ, United States
Posted
Sep 01, 2020
Ref
R1529041
Required Education
Bachelors Degree
Position Type
Full time
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: Business Operations Lead for Global Regulatory Strategy & Policy (GRSP)

Direct Manager: Head, Business Operations

Division: Regulatory Affairs

Location: Summit NJ

Grade: D07

Direct Reports: Yes

About Bristol-Myers Squibb

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.

Business Operations Lead for Global Regulatory Strategy & Policy (GRSP)

Summary

The Business Operations Lead will be a key member of the Business Operations leadership team for Global Regulatory Strategy & Policy. This individual will oversee a team of Global Regulatory Managers, with responsibilities that include line management, people development, operational excellence initiatives, and proactive stakeholder management.

  • Line Management and Team Member Development:
    • Support the GRM Community of Practice knowledge and sharing learning forums to empower team development and initiatives
    • Continually evaluate GRM core competencies for career growth and development opportunities
    • Foster a culture of continuous regulatory improvement and sustainable high standards of performance through training, coaching and stakeholder engagement
    • Direct training and onboarding of new hires for evaluation of development progression
    • In partnership with Business Operations leadership, strategically plan and implement resourcing solutions based on the business need
    • Manage and support Global Regulatory Managers (GRMs) in the coordination and creation of governance-approved global regulatory plans and transmittal to cross functional SMEs for execution
    • Manage and support regulatory work schedules with for assigned projects using common data points and milestones, annual reports, PMR and PMCs
    • Manage, track, review regulatory deliverables for each therapeutic area to ensure BOW is equitable across team members


  • Operational Excellence:
    • Create a bridge for regulatory workflow processes across matrix team model to provide practical solutions to a wide range of challenging technical or operational concerns
    • Drive the development and execution of portfolio reporting and analytics
    • Develop the delivery of end-to-end key regulatory document(s) improvements


  • Stakeholder Management:
    • Strategically seeks opportunities to enhance value of internal stakeholder relationships through early operational engagement and ongoing partnership interactions
    • Demonstrates strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution
    • Communicates regulatory business operations strategy and decision-making across a matrix team model
    • Demonstrate proactive measures to ensure Business Operations team is engaging in valuable regulatory team interactions to coordinate and support GRSP HA activities lead by regional / local liaisons
    • Actively engage with leadership cross functional team members and escalate issues proactively


Qualifications/Requirements
  • Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
  • Solid working knowledge and experience (at least 5 years) with regulatory procedures and submissions (US, EU, or other)
  • Comprehensive understanding of the pharmaceutical industry
  • Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects
  • Ability to manage people effectively
  • Ability to rapidly adapt to different issues and projects at one time
  • Excellent communication and interpersonal skills
  • Comfortable working in a fast-paced environment where speed is paramount
  • Willing to work as a subject matter expert in a matrix team unified around serving the assets
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions for the benefit of meeting deliverable timelines
  • Willingness and ability to effectively cooperate and partner with internal and external stakeholders
  • Understanding of multiple therapeutic areas to effectively manage direct report BOW/projects
  • Increased exposure to global and multifunctional teams


Other Qualifications:
  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals
  • Communicates opinions, facts and thoughts with clarity, transparency and honesty
  • Seeks multiple perspectives and listens openly to others' points of views
  • Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
  • Demonstrates ownership of results within (and beyond) area of responsibility
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved
  • Looks for opportunities for continuous improvement


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.