[Hiring] Lead Specialist, PRC Operations @Viatris

Role Description

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:

• Drives the US PRC approval process as outlined in the US VMAP SOP for assigned therapeutic areas, applying a strong knowledge of FDA regulations and Viatris policies.
• 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
  • 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
  • Launch readiness tracking
• Manage communications between 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
  • Monitoring of deliverables
• 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.
• 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.
• Author and execute on initiatives that enhance and optimize process, structure, and reporting related to Marketing Operations activities.
• 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.
• 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
  • Subject matter expertise on PRC processes
  • Workflow management
  • Complex operational situations
• Supports onboarding, knowledge sharing, and consistent application of established procedures across the team.
• Perform other related duties as assigned.

Qualifications

• Minimum of a bachelor’s degree (or equivalent) and 6-8 years of experience.
• One to three years of pharmaceutical experience and/or project management strongly preferred.
• People management experience preferred.
• 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 a proven track record of working with teams and gaining cross-functional alignment.
• 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, and performance-driven environment.
• Strong hands-on experience with Veeva Vault PromoMats, including workflow management, reporting, and promotional material lifecycle management.
• Experience with Digital Asset Management (DAM) platforms, such as Aprimo, preferred.
• Ability to read and interpret promotional materials and understand the technical aspects of print production and digital media.
• Ability to write comprehensive reports and detailed business correspondence.
• Ability to train large groups on the process if required.
• Basic Math skills and an ability to understand spec sheets.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions.
• Ability to draw inferences and follow prescribed procedures to solve moderately complex problems.

Requirements

• Typically sitting at a desk or table; intermittently sitting, standing, walking, or stooping.
• Periodic travel is required.

Benefits

• Competitive salaries
• Benefits
• Inclusive environment where you can use your experiences, perspectives, and skills to help make an impact.

Company Description

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to 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.

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

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status.