Bristol Myers Squibb
Specialist, U.S. Commercial Regulatory Affairs Operations
Bristol Myers Squibb, Madison, New Jersey, us, 07940
Specialist, U.S. Commercial Regulatory Affairs Operations
Join to apply for the
Specialist, U.S. Commercial Regulatory Affairs Operations
role at
Bristol Myers Squibb Working with Us Challenging. Meaningful. Life‑changing. Here, unique, interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, the work transforms the lives of patients and the careers of those who do it. Bristol Myers Squibb offers competitive benefits, services and programs that give employees the resources to pursue their goals, both at work and in their personal lives. Key Responsibilities Support live review meetings for assigned brand(s), 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 and 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 – backup all other CRA Operations team members as needed, 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 Bachelor’s 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. Compensation Overview Madison – Giralda – NJ – US$68,500 – $83,008 Princeton – NJ – US$68,500 – $83,008 Benefits Medical, pharmacy, dental and vision care. Well‑being support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well‑being resources and a 401(k). Other perks like tuition reimbursement and a recognition program. Equal Employment Opportunity Bristol Myers Squibb is an equal opportunity employer. We celebrate diversity, encourage innovation and invite you to join our dynamic team. We comply with applicable non‑discrimination laws and regulations. If you require reasonable accommodations or adjustments in the recruitment process, please contact adastaffingsupport@bms.com. You can find our full Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Join to apply for the
Specialist, U.S. Commercial Regulatory Affairs Operations
role at
Bristol Myers Squibb Working with Us Challenging. Meaningful. Life‑changing. Here, unique, interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, the work transforms the lives of patients and the careers of those who do it. Bristol Myers Squibb offers competitive benefits, services and programs that give employees the resources to pursue their goals, both at work and in their personal lives. Key Responsibilities Support live review meetings for assigned brand(s), 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 and 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 – backup all other CRA Operations team members as needed, 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 Bachelor’s 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. Compensation Overview Madison – Giralda – NJ – US$68,500 – $83,008 Princeton – NJ – US$68,500 – $83,008 Benefits Medical, pharmacy, dental and vision care. Well‑being support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well‑being resources and a 401(k). Other perks like tuition reimbursement and a recognition program. Equal Employment Opportunity Bristol Myers Squibb is an equal opportunity employer. We celebrate diversity, encourage innovation and invite you to join our dynamic team. We comply with applicable non‑discrimination laws and regulations. If you require reasonable accommodations or adjustments in the recruitment process, please contact adastaffingsupport@bms.com. You can find our full Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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