Promotional Review Committee Specialist, US Commercial Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Sep 20, 2019
Ref
R-03892
Hotbed
Genetown
Required Education
Associate Degree
Position Type
Full time
The US Commercial Regulatory Affairs Promotional Review Committee (PRC) Coordinator is responsible for facilitating the promotional review committee process of assigned products for IPSEN's advertising and promotional materials. The individual will assure process compliance and efficiency of the ad/promo review cycle including: assessing that materials submitted for review are ready to progress, creating meeting agendas, managing meeting logistics and facilitating review meetings. This role is responsible for annotating materials during PRC review meetings, working with brand team member(s) to reconcile comments and progress materials through approval and release within established timelines. The individual will also support the Director, US Commercial Regulatory Affairs in completing post marketing submissions required at the time of initial publication.

Responsibilities will include, but are not limited to, the following:
  • Management of progressing Materials through review workflow for assigned products
    • Manage adherence to timelines for submission of Materials into PRC review and assure that late additions to weekly agenda are limited to exceptions only
    • Confirm Materials uploaded for review conform to process requirements and are submission ready
    • Collaborate with brand/Originator to establish the appropriate relationships between jobs within Veeva PromoMats
  • Route, facilitate PRC review meetings, approval and release of Materials
    • 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 and helps coordinate and schedule PRC Escalation Meetings for assigned products
  • Manage review tool (Veeva PromoMats) and related functionalities
    • Train all PRC members, including advertising agencies
    • 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 to resolve technical challenges for Veeva PromoMat users
    • Trouble-shoot bottlenecks in workflow and incorporate process improvement


Education / Certifications:
  • Associates Degree at a minimum
  • BA/BS Degree preferred


Experience:
  • 1-3 years professional experience
  • Experience working with promotional review committees strongly preferred feedback as directed


Key Technical Competencies Required:
  • Proficiency in Veeva PromoMats
  • Proficiency in Microsoft Office (Word, Power Point, Excel, Outlook) and Adobe
  • Experienced with proofreading technical documents
  • Expert listening skills and ability to probe for undisclosed information
  • Excellent interpersonal skills; accurate and concise oral communications and writing ability
  • Must be able to foster a team environment, collaborate cross functionally and at varying levels of experience to establish high-performing PRC Teams
  • Basic knowledge of pharmaceutical promotional regulations and submission requirements
  • Exceptional attention to detail
  • Ability to lead & facilitate productive and efficient meetings
  • Ability to manage processes/workflows, implement process improvements, & solve problems
  • Ability to conduct process training to internal employees and vendors


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.