Title: PRC CoordinatorLocation: Cambridge, MA (Hybrid)Duration: 06+ Months ( Possible Extension) Job Description:The US Commercial Regulatory Affairs Promotional Review Committee (PRC) Coordinator is responsible for facilitating the promotional review committee process of assigned products for ***’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 processing of pre-and post-marketing submissions to the Office of Prescription Drug Promotion (OPDP). The PRC process utilizes significant cross-functional internal resources, and it is important that the PRCs are managed to function as teams that meet deadlines and adapt to the unique compliance challenges. To this end, the incumbent in this position will be responsible for 1) managing all aspects of offline and live reviews and optimal tracking of materials during their life cycle 2) interfacing with brand/Originator and regulatory to assist with system execution of Regulatory submissions, 3) and providing training to PRC team members on processes and procedures. The expected outcome of this role is to increase compliance and efficiency related to the review and approval of promotional materials for *** prescription drug products in the US.
Responsibilities will include, but are not limited to, the following: - Meeting Facilitation and Material Management for assigned products
- Manage adherence to Standard Operating Procedure (SOP) guidance and timelines for submission of Materials into PRC review
- Ensure materials meet established review criteria prior to being circulated to Reviewers through electronic workflow system (Veeva PromoMats).
- Ensure Materials have included linked References where needed and have established appropriate relationships between related jobs within Veeva PromoMats ·
Material Management
- 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; accurately capture discussion outcomes
- Ensure all reviewer comments on materials are clarified, reconciled, and incorporated prior to final approval of materials
- Prepare OPDP submissions in accordance with established regulatory requirements o Monitor document lifecycle, including reapproval and expiry of Materials in accordance with PRC SOP ·
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
- Participate in team meeting to discuss challenges and propose opportunities for process improvement
- Perform other related Coordinator tasks or projects at the direction of Manager
- Trouble-shoot bottlenecks in workflow and incorporate process improvement feedback as directed
Education / Certifications:- Associate degree at a minimum
- BA/BS Degree preferred
Experience:- 3-5 years professional experience Experience working with promotional review committees strongly preferred
Key Technical Competencies (Required)- Demonstrable expertise in Veeva PromoMats: Understand all steps in standard review workflows, corrective actions/troubleshooting, annotation functionality, agenda management, and report generation
- Proficiency in Microsoft Office (Word, Power Point, Excel, Outlook) and Adobe Acrobat
- Experienced with proofreading complex 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
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Last updated on Apr 26, 2023