Lead Specialist, PRC Operations

Mylan; Morgantown (WV); On-site; USD 66,000 - 127,000; Full time

Job summary

Viatris is seeking a Lead Specialist, PRC Operations in Morgantown, WV to drive the US PRC approval process, coordinate cross-functional reviews, and oversee promotional material lifecycle management. You will manage VMAP activities, liaise with agencies and document owners, and guide launch readiness while supervising contractors and aligning with Marketing Operations.

The role requires a bachelor’s degree and 6–8 years of pharmaceutical experience, strong regulatory knowledge, and excellent

Qualifications

• Bachelor's degree and 6–8 years of experience; pharma experience preferred.
• Knowledge of Medical/Legal/Regulatory (MLR) processes.

Responsibilities

• Drives the US PRC approval process per VMAP SOP and FDA regulations.
• Lead cross-functional PRC meetings and document outcomes."
• Manage end-to-end PRC activities for new product launches, including planning and launch readiness.
• Oversee communications between PRC stakeholders and marketing operations.
• Build monthly metrics and KPI reporting for Marketing Operations.

Skills

FDA regulations

PRC

Project management

Veeva Vault

PromoMats

DAM platforms

Vendor management

Cross-functional

Communication

Education

Bachelor's degree

Tools

Veeva Vault PromoMats

Aprimo

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 able to work with teams, gain cross-functional alignment, and influence without authority.
• Must possess knowledge of all aspects of the promotional review, approval, and material production/digital processes.
• Strong background in process and project management.
• Experience working with vendors and holding them accountable to timelines and budget.
• Ability to maintain customer focus while working in a fast paced, innovative, and performance driven environment.
• Must possess a working knowledge of the Microsoft Office Suite. Must be proactive, meet all deadlines and be able to multi-task. Must be willing and capable of adapting to change, operating in a complex, fast-paced environment and handling additional projects/responsibilities as needed to meet business objectives.
• Strong hands-on experience with Veeva Vault PromoMats, including workflow management, reporting, and promotional material lifecycle management (required).
• Experience with Digital Asset Management (DAM) platforms, such as Aprimo, including asset organization, workflow management, and content lifecycle processes (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 that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
• Typically sitting at a desk or table. Intermittently sitting, standing, walking, or stooping. Periodic travel is required.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
• Remote Office

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $66,000- 127,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

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, or any other characteristic protected by local, state, or federal laws, rules, or regulations.