Promotional Review Committee (PRC) Coordination Manager

TITLE:

Promotional Review Committee (PRC) Coordination Manager

Title: Promotional Review Committee (PRC) Coordination Manager 

Reports To: Head of Commercial Excellence and Capabilities

Location: Remote-US

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

POSITION SUMMARY:

The PRC Coordination Manager serves as the process owner for all Promotional Review Committee planning, operations and communications. This role ensures compliant, efficient, and effective administration of PRC submissions and committee processes, working cross-functionally with Medical Affairs, Regulatory, Legal, Marketing, Sales Training, and external vendors. The PRC Coordination Manager acts as the central authority for process alignment, procedural guidance, and continuous improvement, supporting risk mitigation and regulatory adherence in all commercial activities.  

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

PRC Calendar and Meeting Management 

• Lead the PRC submission and PRC Committee processes, maintain the PRC calendar, and prioritize submissions into PRC based on capacity. 
• Lead pre-meeting reviews, facilitate meetings, document outcomes, close jobs, and move them appropriately in Veeva. 
• Ensure consistent application of PRC standards across jobs when submitted.   
• Escalate significant issues to the PCR Steering Committee as needed 

Stakeholder Engagement & Training 

• Act as the subject matter expert (SME) for PRC process alignment, providing procedural guidance and training to marketing, marketing agencies, and sales training teams.  
• Serve as the primary point of contact for operational questions, process clarifications, and compliance issues related to PRC.   

Post PRC Meeting Content Completion and Monitoring 

• Ensure MLR comments are incorporated into updated versions. 
• Monitor and update status and metadata accordingly when materials are “Approved for Use”  

Regulatory Filing and Documentation Support 

• Act as backup for 2253 submission binder creation and transmission. 
• Monitor off-cycle 2253 submission needs and communicate accordingly. 

Process Optimization and System Enhancements 

• Continuously improve PRC workflows and tools as the process owner to streamline processes and maintain compliance. 
• Develop, maintain and update relevant policies, Standard Operating Procedures (SOPs), and work instructions in line with regulatory requirements and internal best practices. 
• Liaison with IT for designing, testing and implementing Veeva system enhancements. 

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Business, Healthcare Administration, or related field. 

• 5+ years of experience in pharmaceuticals or biotech industry, preferably in promotional review, regulatory affairs, or marketing operations. 

• Strong knowledge of regulatory requirements (e.g., FDA) and industry standards for pharmaceutical promotional materials.  

• Demonstrated expertise in process management, cross-functional collaboration, and operational excellence. 

• Excellent communication, organizational, and analytical skills. 

• Experience with vendor management, policy development, and delivering training. 

• Proficiency with compliance systems (e.g., Veeva Vault) and project management tools is a plus. 

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• High attention to detail and commitment to compliance. 
• Ability to work independently and maintain neutrality in process oversight. 
• Strong stakeholder management and facilitation skills. 
• Capacity to drive process improvements and manage change in a dynamic environment. 

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts

GUIDING PRINCIPLES:

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.  The employee may perform other functions that may be assigned.  Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled