Senior Manager, GRS Heme/Onc

Bristol Myers Squibb • Princeton, NJ

2d • $148,150 - $179,519 • Onsite

About The Position

USRL, working on the Hematology and Oncology Strategy GRS Organization at BMS. In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across Therapy Area. Support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT Propose approaches to resolve regulatory issues and appropriately drive speed to patients. Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities. Support the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP) etc. Understanding of scientific content, drug development and regulatory requirements. Participate in the assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g., registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom. Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops. Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities). Facilitate identification of and internal agreement on target labeling

Requirements

• Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience
• At least 2 years of relevant regulatory experience
• A basic knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required.
• Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers within a cross-functional environment.
• Proven ability to work with outside partners.
• Demonstrated ability to be solution-oriented.
• 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.

Nice To Haves

• Occasional, domestic travel

Responsibilities

• Develop strategic and operational plan for the development and the registration of assets across Therapy Area.
• Support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
• Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT.
• Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
• Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input.
• Contribute to building a strong and trusted relationship with Health Authorities.
• Support the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries.
• Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP) etc.
• Participate in the assessment of regulatory precedence and regulatory scientific guidelines.
• Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g., registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom.
• Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
• Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).
• Facilitate identification of and internal agreement on target labeling.

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree