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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.

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Senior Director, Team Leader, GRS International Therapeutic Area

Position Summary

Support the GRS International Therapeutic Area Lead in this strategic leadership position, and company objectives.

Team Leadership responsibility for GRS International strategy over a defined part of the TA portfolio (assets) including line management over ERL (EU regulatory Lead) and IRL (Intercon Regulatory lead).

Act as ERL or IRL for defined assets, and ensure effective stakeholder communication/alignment across function, as agreed with GRS International Lead.

Position Responsibilities

Responsibilities will include, but are not limited to the following:

Senior Director Role

Support the GRS International Therapeutic Area lead in this strategic leadership position responsible for leading and developing the holistic regional regulatory strategies across EU and Intercon region and markets, overseeing external and internal engagement as required, and providing guidance and leadership to the preparation, review and evaluation of submission documents to health authorities across the International region.

Serve as a Senior Director with the following responsibilities:

Formulates regulatory strategy in collaboration with the GRS international TA Lead and Global Strategy colleagues, and oversees implementation of activities needed to secure approval of new drugs or approvals for expanded indications across product portfolio in line with BMS portfolio strategy. Formulates strategy for early assets (as assigned) for successful HA interactions in the regions, support pipeline meetings, and external engagement to advance science and pipeline Works in close partnership with internal/external key stakeholders to effectively manage project development timelines and expectations. Provides strategic leadership in business processes and cross-functional partnerships. Leads, mentors, and guides development of talents, within and across specific functional expertise, across the GRS International region. Senior review of HA documentations, as assigned by TA lnt. Lead

GRS International Team Leader (Line Manager and SME)

Responsible for leading, managing, mentoring, and developing a team of ERL and IRL Directly handling regional strategy development for defined assets acting as ERL or IRL Acts as regulatory representative on various company-wide projects and initiatives, as applicable. Working with regulatory colleagues across GRS as per operating model -- Global Regulatory Leaders, GRT members..-- on assigned development assets and marketed products:

Drive international therapeutic regulatory strategies and operational plans for identified investigational and marketed products, in line with Global strategy. Review/provide counsel on product development plans.

Influences and imparts broad expertise regarding international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.

Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.

Serve as the primary interface with health authorities on assigned projects, and support the ones led by ERL and IRL.

Ensure a culture of learning, trust and timely sharing of information across Intercon and EU, learning from one another and establishing best practices.

Degree Requirements

• Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in therapeutic area of disease drug development preferred and expected.

Experience Requirements

• 12 years + pharmaceutical industry experience, including 8-10 years in regulatory sciences. Global experience strongly preferred with command of International experience, EU and/or Intercon.

Key Competency Requirements

• Thorough knowledge of the drug research, development, and commercialization process.

• Demonstrated specific expert in one or more key areas - Drug Development/ Biopharmaceutics/Clinical/Promotional.

• Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.

• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.

• Must be able to innovate, analyze and solve critical/complex business problems.

• Leadership skills.

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. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1584269

Updated: 2024-09-10 05:16:46.239 UTC

Location: Uxbridge-GB

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.