Promotional Review Committee Lead, US Commercial Regulatory Affairs

The US Commercial Regulatory Affairs Promotional Review Committee Lead is responsible for overseeing the US promotional review committee (PRC) process for IPSEN's advertising and promotional materials. The incumbent will coordinate and facilitate the review process for assigned products and assure overall excellence and efficiency of the review process for the portfolio. S/he will capture and track efficiency and review excellence KPI's, facilitate PRC escalation meetings and Governance Committee meetings. This individual will support the Director, US Commercial Regulatory Affairs in completing Post marketing submissions required at the time of initial publication for assigned products.

Responsibilities will include, but are not limited to, the following:

• Oversee the management and forecasting of materials across all PRC teams
  • Ensure sufficient live meeting time is scheduled for each PRC team through working with brand leads and agencies to develop and update annual, quarterly, monthly and weekly PRC plans
  • Attend brand planning, strategy, and status meetings as needed
  • Oversee adherence to timelines for submission of materials into PRC review; and ensure that late additions to weekly agenda are limited to exceptions only
  • Partner with brand and channel teams to ensure tactical plans are executed in accordance with PRC plans and process

• Oversee the other PRC Coordinator(s) across all PRC teams to ensure materials are routed, approved and released in accordance with PRC SOP
  • Ensure materials meet established review criteria prior to being circulated to Reviewers through electronic workflow system (Veeva PromoMats)
  • Move materials through the workflow in accordance with published timelines
  • Facilitate efficient meetings and focus on key issues, with the goal of bringing the group to consensus
  • Ensure all reviewer comments on materials are clarified, reconciled and incorporated prior to final approval of materials
  • Prepare OPDP 2253 submissions in accordance with established regulatory requirements
  • Monitor Archival and Expiry of Materials in accordance with PRC SOP
  • Manages expedited review process, coordinates and facilitates PRC Escalation Meetings

• Manage review tool (Veeva PromoMats) and related functionalities
  • Develop training and deliver to all PRC members, including advertising agencies. Assign and periodically confirm Veeva users have the correct access
  • Monitor behaviors and practices to assure responsibilities in the PRC SOP are performed effectively by each role. Identify issues and communicate instances of noncompliance to management
  • Ensure appropriate and efficient leverage of tool during meetings
  • Partner with IT and Brand to resolve technical challenges for Veeva PromoMat users and provide support for process and system enhancements
  • Trouble-shoot bottlenecks in workflow and incorporate KPI feedback actively contributing as the subject matter expert to development in these areas
  • The PRC Lead will take the lead or co-lead projects and/or assignments as required to ensure department goals are achieved

• Solicit feedback/provide recommendations for improving PRC effectiveness from stakeholders. Facilitate Executive PRC Meetings, Governance Committee Meetings & execute special projects as required by management
  • Consolidate quarterly metrics to facilitate self-evaluation opportunity to each PRC team
  • Compose and issue minutes associated with Executive PRC Meetings and Governance Committee meetings

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.