Lead Specialist, PRC Operations

Viatris•Torrington, WY

1d•$66,000 - $127,000•Remote

About The Position

The Lead Specialist, PRC Operations drives the US PRC approval process for assigned therapeutic areas in accordance with the US VMAP SOP, applying knowledge of FDA regulations and Viatris policies governing promotional material review. The role guides agencies and document owners on submission standards, facilitates cross-functional PRC meetings, and coordinates review comments, outcomes, and follow-up actions. The position leads end-to-end PRC operational support for new product launches, including review planning, asset prioritization, timeline and resource coordination, and launch readiness tracking. It coordinates communications among PRC stakeholders, provides operational direction to contractors, plans and prioritizes workload, and identifies capacity constraints. The role also advances process improvement, supports the lifecycle and deployment of educational and commercial assets, develops operational initiatives, and produces monthly metrics and KPI reports. The Lead Specialist manages department training and supports users of Veeva Vault and the VMAP review process. As a subject matter expert, the role provides guidance and coaching to PRC team members, supports onboarding and consistent application of procedures, and performs other related duties as assigned. The position is remote, with periodic travel required.

Requirements

Minimum bachelor's degree or equivalent and 6–8 years of experience; a combination of experience and education may be considered.
Knowledge of promotional review, approval, and material production and digital processes.
Knowledge of the legal and regulatory landscape for pharmaceutical marketing, including Medical/Legal/Regulatory (MLR) processes.
Knowledge of compliant engagement of healthcare professionals (HCPs) and required reporting.
Excellent communication and facilitation skills, with a demonstrated ability to work with teams, gain cross-functional alignment, and influence without authority.
Strong background in process and project management.
Experience working with vendors and holding them accountable to timelines and budget.
Ability to maintain customer focus in a fast-paced, innovative, performance-driven environment.
Working knowledge of Microsoft Office Suite; ability to meet deadlines, multitask, adapt to change, and handle additional projects and responsibilities.
Strong hands-on experience with Veeva Vault PromoMats, including workflow management, reporting, and promotional material lifecycle management.
Ability to read and interpret promotional materials and understand technical aspects of print production and digital media.
Ability to write comprehensive reports and detailed business correspondence and to train large groups when required.
Basic math skills and ability to understand specification sheets.
Ability to solve moderately complex problems using analysis, ingenuity, inferences, and prescribed procedures.
Ability to meet the physical demands of the role, which typically involve sitting at a desk or table and intermittently sitting, standing, walking, or stooping.

Nice To Haves

One to three years of pharmaceutical experience and/or project management experience, including meeting facilitation skills.
People management experience.
Experience with Digital Asset Management (DAM) platforms such as Aprimo, including asset organization, workflow management, and content lifecycle processes.

Responsibilities

Drive the US PRC approval process for assigned therapeutic areas under the US VMAP SOP, applying FDA regulations and Viatris policies.
Guide marketing agencies and document owners on PRC submission standards and processes.
Lead cross-functional PRC meetings, including agenda development, discussion facilitation, documentation of outcomes, and action follow-up.
Partner with Medical, Regulatory, Legal, and Marketing reviewers to resolve comments and support adherence to PRC processes and timelines.
Coordinate end-to-end PRC operations for new product launches, including review planning, asset prioritization, timelines, resources, and launch-readiness tracking.
Manage communications among PRC stakeholders on marketing operations and cross-functional initiatives.
Provide day-to-day operational direction and oversight to contractors, including work assignments, prioritization, workload coordination, deliverable monitoring, and performance feedback.
Assess promotional material volume, anticipated review timelines, and resource needs; lead workload planning and prioritization, identify capacity constraints, and recommend adjustments.
Develop work groups and pursue continuous improvement in Marketing Operations, including VMAP, lifecycle management, demand generation of marketing assets, and product marketing programs.
Partner with marketing teams, advertising agencies, and external partners to ensure promotional materials are complete for regulatory submissions.
Support internal departments with submission, review, approval, activation, deployment, utilization, and expiration or destruction of educational and commercial assets.
Author and execute initiatives to enhance and optimize Marketing Operations processes, structure, and reporting.
Build, provide, and capture monthly Marketing Operations metrics and KPI reports.
Manage the department training schedule and content, and assist in training Veeva Vault users and VMAP review participants.
Serve as a subject matter expert on the VMAP process and Veeva system.
Provide PRC team members with day-to-day guidance, coaching, and expertise on processes, workflow management, and complex operational situations; support onboarding and knowledge sharing.
Perform other related duties as assigned.