Specialist, U.S. Commercial Regulatory Affairs Operations

Role Summary

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, 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.

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 and provide recommendations for improving PReP effectiveness.
  • Support onboarding of new users (internal and 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.