Job Title- PRC Coordinator

Duration- 08 / 30 / 2024 3 months-up-to 6 months.

Cambridge ,MA

Job Summary :

This role is a contract role (Short-term assignment) the assignment could be as short as 3 months-up-to 6 months.

Job Summary :

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 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 Ipsen prescription drug products in the US.

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

o Manage adherence to Standard Operating Procedure (SOP) guidance and timelines for submission of Materials into PRC review

o Ensure materials meet established review criteria prior to being circulated to Reviewers through electronic workflow system (Veeva PromoMats).

o Ensure Materials have included linked References where needed and have established appropriate relationships between related jobs within Veeva PromoMats ·

Material Management

o Move materials through the workflow in accordance with published timelines

o Facilitate efficient meetings and focus on key issues, with the goal of bringing the group to consensus; accurately capture discussion outcomes

o Ensure all reviewer comments on materials are clarified, reconciled, and incorporated prior to final approval of materials

o 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

o Train all PRC members, including advertising agencies

o 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 o Ensure appropriate and efficient leverage of tool during meetings

o Participate in team meeting to discuss challenges and propose opportunities for process improvement

o Perform other related Coordinator tasks or projects at the direction of Manager

o Trouble-shoot bottlenecks in workflow and incorporate process improvement feedback as directed

Education / Certifications :

• Associates Degree at a minimum
• BA / BS Degree preferred but an Associates degree and experience is allowed.

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

Additional Info

PRC Coordinator Intake notes :

• Remote role
• Up to 20-hours per week
• Fast-paced environment, great multi-tasker
• 3 to 5 years exp. minimum
• Background in editing (University papers, Company Newsletters)
• Deadline / SOP driven
• Excellent writing skills (English)
• Excellent reading and verbal comprehension skills
• Excellent inter-personal, meeting facilitation skills
• Super detailed-orientated
• High queue driven
• OPDP submission experience (eCTD 2253, Subpart H)
• Demonstrated proficiency in Veeva Vault Promomats is a must
• Will acknowledge C-level administrative assistant background
• East Coast hours (1pm as a start time, with an hour lunch end time 5pm)
• May have mandatory PRC 9am meeting depending on assignment

PRE-SCREENING QUESTIONS FOR SUPPLIERS TO ASK APPLICANTS (Submit these answers into the system in a Word Doc) :

1. How long have you been working with the Veeva platform and have you worked with any other electronic review systems?

2. Were you a Coordinator for a Medical Review Process or a Commercial Review Process?

3. Please list the types of Coordinator tasks you typically perform on a daily basis.

4. Are the materials you support mostly reviewed offline or do you have regular live meetings?

5. If you have regular meetings, who is responsible for creating and prioritizing agendas?

6. Please describe your role during a typical live review committee meeting.

7. If a job is in Revise and Resubmit status, what does that mean and what would the next steps be?

8. Does your current role require you to do a quality check of materials? If so, at what stage(s)?

9. What do you feel are the key skills and strengths you would bring to this position?

10. Describe how you built relationships while working cross-functionally

11. Have you participated in developing SOPs or Work Instructions? If so, describe

TB PH

Last updated : 2024-05-10