Director, Global Labeling Strategy, New Product Portfolio

Bristol Myers Squibb; Uxbridge; On-site; USD 182,000 - 228,000; Full time

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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.

The Director, Global Labeling Strategist, plays a critical role in overseeing the development of labeling content (TPL, CCDS, USPI, and EU SmPC) and strategies for early assets. From early development through regulatory approval, this role ensures the delivery of effective and competitive labeling documents that drive differentiation and compliance in global markets.

Global Labeling Strategy & Execution

• Lead development of Labeling strategy for new products by collaborating with cross-functional teams during clinical development, regulatory submission and launch.
• Utilize insights from competitor analysis, labeling expertise and regulatory knowledge to author and develop competitive and optimal Target Product Labeling that aligns with market needs, company objectives and regulatory requirements.
• Create and communicate initial labeling frameworks that meet with market needs and regulatory standards across global markets.
• Drive internal alignment on labeling strategy and proactively identify and manage key risks.
• Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities.

Operational oversight

• Conduct risk assessments to address labeling challenges and ensure labeling readiness.
• Create labeling documents (TPL, CCDE, EUSPC, USPI), managing or overseeing initial negotiations with health authorities.
• Ensure effective planning and execution of all cross-functional labeling activities to maximize speed and quality.

Stakeholder Management

• Lead Labeling Strategy Team (LST).
• Cultivate relationships with internal teams (Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical...) to ensure seamless labeling strategy execution.
• Coordinate labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.

Policy Influence & Knowledge Sharing

• Identify opportunities to influence regulatory policy and climate with respect to labeling content, and process.
• Mentor, coach, and develop team members to foster a high performing culture, as applicable.
• Lead key initiatives (Process Improvements, procedural documents (e.g. Policies, SOPs, working instructions, job aids).
• Innovation: Development of new tools, technologies to support efficient global label development and worldwide submissions and approvals.

The starting compensation for this job is a range from $182,000 - $228,000, plus incentive cash and stock opportunities (based on eligibility).

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail].

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.