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. 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. Read more: careers.bms.com/working-with-us.

A member of the Submissions team of the Specialist level in US Commercial Regulatory Affairs Operations (CRA Ops) supports the Promotional Review Process (PReP) through a broad range of responsibilities and tasks, primarily through the submission of Promotional Material to the FDA. The Submissions team member is responsible for the review and approval of submissions packages as well as the completion of all relevant information and data and the proper submission to the FDA.

Key Responsibilities

Support Brand Matrix team across all therapeutic franchises, including Value Access and Payment (VAP), Multichannel Digital team, and Corporate Affairs and drive review workflows through the timely submission of Promotional Material

Form FDA-2253 SubmissionsReview all external facing promotional material to ensure high quality of material that is suitable for final approval and submissionEnsure material is consistent with established BMS and brand practices and standardsAssist with review of 2253 packages prior to submission to verify compatibility with requirementsManage the preparation and finalization of FDA Form 2253 submission packages to ensure BMS complies with FDA requirementsSubmit completed package to third party vendor to submit to FDA electronic gatewayMaintain all 2253 related recordsMaintain up-to-date knowledge of law, regulations and policies enforced by Federal and State governments as they relate to OPDP AdPromo submissions and promotional labelingOPDP Accelerated Approval/Advisory Comment SubmissionsReview electronic reference packages for Accelerated Approval or Advisory Comment submissionDraft cover letters, ensure up-to-date templates and other binder materials are available and easily accessible for department team membersSubmit completed package to third party vendor to submit to FDA electronic gatewayWork with outside advertising agencies on day-to-day operations (ensure accurate preparation of review materials including OPDP preclearance submissions, lead weekly status meetings, in collaboration with BMS Production)

Support US PReP Process

Ensure adherence to Marketing Decision-Making ModelSolicit feedback & provide recommendations for improving PReP effectivenessSupport onboarding of new users (internal & external) through brand PReP process and Veeva PromoMats systemEnsure adherence to PReP process and provide related support to the brandSupport partnership with BMS IT/Veeva support to troubleshoot technical challenges and workflow enhancementsBuild relationships and communicate with matrix team members to highlight identified material content issues to help drive solutionsMaintain expert level understanding of internal routing systems, and be a resource to ensure matrix colleagues are trained and educated on use of systems and overall review process to members of the extended matrix team

Support CRA Operations Team

Back-up all other CRA Operations team members as needed, including other PREs and CRA Ops FDA Submissions across all therapeutic areasExecute special projects as required by CRA Operations managementPReP Metrics collection and updating of Tableau tracking siteMaintain flexibility as to working locations across New Jersey to ensure full coverage is available at both PPK, Summit, and New Brunswick sitesParticipate in the training and onboarding of new FTE and contractor, across sites if neededMaintain online resources through brand and CRA SharePoints to ensure all records are current

Requirements

BA/BS degree required; Minimum of 1 year supporting promotional review processesQualificationsCandidate should be qualified with BA/BS degreeRegulatory operations experience with knowledge of promotional regulatory requirements, or related experience (minimum 1 year experience)Strong written communication skills and demonstrated ability to communicate ideas clearly, especially with reading comprehension, grammar, spelling and typingStrong verbal skills with the ability to speak with confidence, concise and complete with the ability to step back and listenStrong editorial and technical skillsExperience and willingness to work in a fast-paced environment with tight timelines and large deliverables, and to possess strong attention to detail and organizational skillsBroad “hands on” related pharmaceutical experience (minimum of 1-year pharmaceutical industry/regulatory experience in relevant area)High level of interpersonal skills; ability to regularly interact with diverse multifunctional teams and matrix partners, including senior leadersStrong working knowledge of Adobe Acrobat, MS Office and electronic routing systems

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 a supportive culture, promoting global participation 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 an 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/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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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