Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Senior Specialist, Regulatory Operations (Reg Ops) supports the Promotional Review Process (PReP) through a broad range of responsibilities and tasks. The Senior Specialist, Reg Ops is responsible for the content of promotional material while it is under review by the brand matrix team. The Senior Specialist Reg Ops will facilitate PReP meetings and workflows, the capture of content adjustments, and ensure correct versioning of updated material. The Senior Specialist Reg Ops also provides editorial and proofreading review of material, ensuring the quality of all final material.

Key Responsibilities

* Support assigned Brand Matrix team 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 teams 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 Reg Ops Associates and CRA Ops Submissions
* Ensure all FDA Submissions under the purview of CRA Operations are completed:
* Assist CRA advisors and PReP Coordinators to facilitate label updates including strategy for Subpart Binder submission
* Assist CRA Operations Submissions team as needed to create and submit 2253 submissions packages
* Review and manage 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 PPK, Summit, and New Brunswick sites
* Participate in the training and onboarding of new FTE and contractor Regulatory Operations Associates, across sites if needed
* Maintain online resources through brand and CRA SharePoints to ensure all records are current.

Requirements

BA/BS degree required; Minimum of 3 years in managing promotional review process preferred.

Qualifications

* Regulatory operations experience with knowledge of promotional regulatory requirements, or related experience (minimum 3 years experience preferred)
* 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
* Broad hands on related pharmaceutical experience (minimum of 3 years pharmaceutical industry/regulatory experience in relevant area preferred)
* 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
* Candidate should be qualified with Bachelors Degree

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.