Vice President, Capital Markets, Fixed Income, Compliance Testing
FINRA
Specialist, U.S. Commercial Regulatory Affairs Operations
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $68,500 - $83,008 per year
Job Level
Junior
Tech Stack
Tableau
About the role
- 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.
- Back-up all other CRA Operations team members as needed, including other PREs and CRA Ops FDA Submissions across all therapeutic areas.
- 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.
Requirements
- 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.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory operationspromotional regulatory requirementseditorial skillstechnical skillsattention to detailorganizational skillsPReP Metrics collectionFDA submissionsproofreadingcontent management
Soft skills
written communicationverbal communicationinterpersonal skillsteam collaborationlistening skillsproblem-solvingtraining and onboardingfeedback solicitationrelationship buildingadaptability
Certifications
Bachelor's degree
