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Senior Manager, GRS Heme/Onc

$148.15k - $179.52k

Bristol-Myers Squibb

Senior Manager, GRS Heme/Onc (Princeton, NJ, US) Working with BristolMyersSquibb means tackling challenging, meaningful, and life‑changing work that transforms patients’ lives and careers. In this role, you will support the Hematology and Oncology Strategy within the GRS organization, collaborating closely with regional strategists and global regulatory teams to ensure timely, high‑impact regulatory outcomes. Responsibilities Partner with regional strategists/liaisons or the GRL Team Leader to develop strategic and operational plans for the development and registration of assets across the therapy area. Support marketing application submission teams for indications at the regulatory filing stage by creating strategy and content for global dossiers. Develop contingency plans with the GRL or Team Leader to achieve regulatory objectives, including risk identification and mitigation. Propose approaches to resolve regulatory issues and drive speed to patients. Lead and/or support global health authority interactions, preparing objectives, briefing materials, and facilitating content discussions. Build strong, trusted relationships with Health Authorities and contribute to a single regulatory voice within the organization. Prepare and contribute to responses to queries from Health Authorities for respective regions/countries. Provide input to key development documents, including clinical protocols, clinical and non‑clinical reports, statistical analysis plans, DMC charters, Investigational Brochures, DSURs, and U.S. regulatory documents such as BTD, ODD, iPSP. Assess regulatory precedents, scientific guidelines, and regulatory lessons learned, collaborating with clinical and regulatory experts. Track schedules and attendance for relevant public‑private regulatory meetings or FDA workshops. Facilitate internal agreement on target labeling and scientific background. Qualifications Scientific background: Ph.D., M.D., PharmD, MS, or BS, or equivalent professional experience. At least 2 years of relevant regulatory experience. Basic knowledge of drug development and U.S. FDA regulations, policies, and guidelines. Strong interpersonal and cross‑functional collaboration skills. Proven ability to work with outside partners and be solution‑oriented. Excellent communication, ownership of results, and ability to drive continuous improvement. Travel Occasional domestic travel. Compensation Starting compensation range: $148,150 – $179,519 (full‑time employee). Additional incentive cash and stock opportunities may be available. Final pay will be determined based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP). Financial Well‑being & Protection: 401(k) plan, disability, life insurance, accident insurance, supplemental health insurance, business travel protection. Paid Time Off: Flexible time off, unlimited paid national holidays (varies by location), paid vacation, optional volunteer days, and annual Global Shutdown. Equal Employment Opportunity We will consider qualified applicants with arrest and conviction records, pursuant to applicable laws. For additional information, visit careers.bms.com/eeo-accessibility. #J-18808-Ljbffr Bristol-Myers Squibb

Vacancy posted 3 days ago
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