Specialist, U.S. Commercial Regulatory Affairs Operations en Bristolmyerssquibb

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 Promotional Review Editor (PRE) 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 by working directly with the US Commercial Brand teams.  The PRE is responsible for the content of promotional material while it is under review by the brand matrix team.  The PRE will facilitate PReP meetings and workflows, the capture of content adjustments, and ensure correct versioning of updated material.  The PRE also provides editorial and proofreading review of material, ensuring the quality of all final material. 

Key Responsibilities

Support assigned Brand Matrix team across all therapeutic franchises, including Market Access (MAx), Multichannel Digital team, and Corporate Affairs and drive review workflows through the management of the content of promotional material.

• Support live review meetings for assigned brand(s), participating in review discussion with advisors, capturing Matrix team’s consensus comments.
• Facilitate discussions and Matrix team review of material through workflow and logistical support.
• Provide editorial and proofreading oversight.
• Review all external facing promotional material to ensure high quality of material that is suitable for final approval and submission.
• Ensure material is consistent with established BMS and brand practices and standards.
• Assist in training and onboarding of new Matrix team members in online systems as well as information and background on brand team and promotional product history to new team members.
• Maintain references specific to brands, including frequently used references and typical phraseology.
• Participate in Escalation Meetings with brand and functional area leadership.
• Work 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)
• Work with brand matrix team during product and indication launches and label updates, to ensure all materials are reviewed and approved in a timely manner and deadlines are met.
• Participate in off-site product launches as necessary.
• Ensure ISI is fully checked for quality and accuracy in the immediate aftermath of approval – applicable to all brands on an as-needed basis.

• Support US PReP Process
  • Ensure adherence to Marketing Decision-Making Model
  • Solicit feedback & provide recommendations for improving PReP effectiveness.
  • Support onboarding of new users (internal & external) through brand PReP process and Veeva PromoMats system
  • Ensure adherence to PReP process and provide related support to the brand.
  • Support partnership with BMS IT/Veeva support to troubleshoot technical challenges and workflow enhancements.
  • Build relationships and communicate with matrix team members to highlight identified material content issues to help drive solutions.
  • Maintain 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 areas.
  • Ensure all FDA Submissions under the purview of CRA Operations are completed:
    • Work with CRA advisors and Marketing Operations to facilitate label updates including providing strategy for Subpart Binder submission.
    • Work with CRA Operations Submissions team as needed to create and submit 2253 submissions packages.
    • Manage and review all Subpart and Advisory Comment binder submissions to FDA for assigned brand.
  • Execute special projects as required by CRA Operations management.
    • PReP Metrics collection and updating of Tableau tracking site.
    • Annual PReP Survey of all Brand Teams, tracking performance and satisfaction.
    • Interface with online ISI Modularization tool, updating content and ensuring correct information and formatting.
  • Maintain flexibility as to working locations across New Jersey to ensure full coverage is available at both Lawrenceville or Madison sites.
  • Participate in the training and onboarding of new FTE and contractor PREs, across sites if needed.
  • Maintain online resources through brand and CRA SharePoint to ensure all records are current.

Qualifications 

• Bachelors’ degree required.
• Regulatory 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 typing.
• Strong verbal skills with the ability to speak with confidence, concise and complete with the ability to step back and listen.
• Strong editorial and technical skills
• Experience and willingness to work in a fast-paced environment with tight timelines and large deliverables, and to possess strong attention to detail and organizational skills.
• High level of interpersonal skills; ability to regularly interact with diverse multifunctional teams and matrix partners, including senior leaders.
• Strong 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.

Madison - Giralda - NJ - US: $68,500 - $83,008 Princeton - NJ - US: $68,500 - $83,008

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

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/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 [email protected]. 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/

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

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