Lead Specialist, PRC Operations

Viatris; United States; On-site; USD 110,000 - 140,000; Full time

Job summary

Viatris is seeking a Lead Specialist, PRC Operations to drive the US PRC approval process for promotional materials, applying deep knowledge of FDA regulations and VMAP workflows. You will coordinate cross-functional teams, manage timelines, mentor staff, and optimize processes across Marketing Operations and external agencies, ensuring timely submissions and KPI reporting.

A bachelor's degree and 6–8 years pharma experience are preferred, with strong leadership and communication skills to guide

Qualifications

• Bachelor's degree (or equivalent) with 6–8 years of pharmaceutical or project management experience.
• Deep knowledge of promotional review, approval, and material production/digital processes.
• Excellent communication and facilitation skills with proven leadership ability.

Responsibilities

• Drives the US PRC approval process per VMAP SOP and FDA rules.
• Lead cross-functional PRC meetings and document outcomes.
• Coordinate end-to-end PRC operations for new product launches.
• Manage communications between PRC stakeholders and marketing operations.
• Oversee contractors supporting PRC activities and resource planning.
• Provide monthly metrics and KPI reporting for Marketing Operations.
• Mentor team members on PRC processes and VMAP system.

Skills

Project management

Meeting facilitation

Cross-functional collaboration

FDA/regulatory knowledge

Education

Bachelor's degree

Tools

Veeva Vault

Job description

Mylan Pharmaceuticals Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here's how the Lead Specialist, PRC Operations role will make an impact:

Key responsibilities for this role include:

• Drives the US PRC approval process as outlined in the US VMAP SOP for assigned therapeutic areas. This includes applying a strong knowledge and understanding of the FDA regulations and Viatris policies governing the promotional material review process.
• Liaise with and guide marketing agencies and document owners on PRC submission standards & process.
• Lead and facilitate cross-functional PRC meetings, including agenda development, discussion management, documentation of review outcomes, and follow-up on required actions. Partners with Medical, Regulatory, Legal, and Marketing reviewers to facilitate timely resolution of comments, maintain productive discussions, and support adherence to established PRC processes and timelines.
• Leads and coordinates end-to-end PRC operational activities for new product launches, including review planning, asset prioritization, timeline and resource coordination, and launch readiness tracking.
• Manage communications between the PRC stakeholders on marketing operations and cross functional initiatives.
• Provides day-to-day operational direction and oversight to contractors supporting PRC activities, including work assignments, prioritization, workload coordination, and monitoring of deliverables. Provides performance feedback and identifies resource or service delivery concerns for resolution with Marketing Operations management.
• Partners with Marketing and cross-functional stakeholders to assess upcoming promotional material volume, anticipated review timelines, and operational resource needs. Leads PRC workload planning and prioritization discussions, identifies potential capacity constraints and scheduling conflicts, and recommends adjustments to support business priorities and established review timelines.
• Seek opportunities and develops work groups for continuous improvement and process enhancement in support of Marketing Operations activities including but not limited to the VMAP process, Lifecycle Management and Demand Generation of Marketing Assets and product marketing programs.
• Partners with marketing, advertising agencies and external partners to ensure development of promotional materials are complete for regulatory submissions.
• Ensures the execution of operational support and guidance to multiple internal departments to facilitate the submission, review, approval, activation, deployment, utilization, expiration/destruction of educational and commercial assets provided to external and internal stakeholders.
• Author and execute on initiatives that are identified to enhance and optimize process, structure and reporting related to activities driven by the Marketing Operations department.
• Builds, provides, and captures monthly metrics and KPI reporting for Marketing Operations.
• Manages the department training schedule, content, and assists in the delivery of new and current users of the Veeva Vault system and those participating in the VMAP review process.
• Serve as a subject matter expert for the VMAP process and Veeva system.
• Serves as a senior operational resource to PRC team members, providing day‑to‑day guidance, coaching, and subject matter expertise on PRC processes, workflow management, and complex operational situations. Supports onboarding, knowledge sharing, and consistent application of established procedures across the team.
• Perform other related duties as assigned.

The minimum qualifications for this role are:

• Minimum of a bachelor's degree (or equivalent) and minimum of 6-8 years of experience. However, a combination of experience and/or education will be taken into consideration. One to three years of pharmaceutical experience and/or project management (including meeting facilitation skills) strongly preferred. People management experience preferred.
• Must possess knowledge of all aspects of the promotional review, approval, and material production/digital processes.
• Knowledge of the Legal and Regulatory landscape pertaining to pharmaceutical marketing, including Medical/Legal/Regulatory (MLR) processes.
• Knowledge of compliant engagement of HCPs and required reporting.
• Excellent communication and facilitation skills with proven track record of being