Lead Specialist, PRC Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the US PRC approval process for designated therapeutic areas in accordance with the US VMAP SOP.

• Implement FDA regulations and Viatris policies during the review of promotional materials.

• Collaborate with marketing agencies and document owners to ensure adherence to PRC submission standards and procedures.

• Lead and manage cross-functional PRC meetings, including setting agendas, facilitating discussions, documenting outcomes, and ensuring follow-up actions.

• Work alongside Medical, Regulatory, Legal, and Marketing reviewers to address feedback and uphold PRC timelines.

• Coordinate all PRC operational activities for new product launches, focusing on planning, prioritization, resource allocation, and readiness tracking.

• Manage communications among PRC stakeholders regarding marketing operations and cross-functional initiatives.

• Supervise contractors involved in PRC activities, including task assignments, prioritization, workload distribution, deliverables, and feedback.

• Organize and prioritize PRC workloads, recognizing capacity limitations and scheduling conflicts, and suggest necessary adjustments.

• Create continuous-improvement work groups for VMAP, lifecycle management, demand generation, and product marketing initiatives.

• Partner with marketing, advertising agencies, and external collaborators to finalize promotional materials for regulatory submissions.

• Assist with the submission, review, approval, activation, deployment, utilization, and expiration/destruction of educational and commercial assets.

• Develop and implement initiatives aimed at optimizing Marketing Operations processes, structures, and reporting systems.

• Generate and maintain monthly metrics and KPI reports.

• Manage training schedules and content for the department; provide support for Veeva Vault and VMAP training sessions.

• Act as a subject matter expert on the VMAP process and Veeva system.

• Offer senior operational guidance, coaching, and expertise to PRC team members; facilitate onboarding and knowledge sharing activities.

• Perform additional related duties as assigned.

⛳️ Requirements

• A minimum of a bachelor’s degree (or equivalent), with at least 6-8 years of relevant experience; a combination of experience and/or education will be considered.

• Preferred 1 to 3 years of experience in pharmaceuticals and/or project management.

• People management experience is preferred.

• Knowledge of FDA regulations and Viatris policies related to the review of promotional materials.

• Familiarity with the promotional review, approval, and material production/digital processes.

• Understanding of the Legal and Regulatory landscape concerning pharmaceutical marketing, including Medical/Legal/Regulatory (MLR) processes.

• Awareness of compliant engagement with HCPs and the necessary reporting requirements.

• Exceptional communication and facilitation abilities.

• Strong expertise in process and project management.

• Experience working with vendors and ensuring accountability for timelines and budgets.

• Proficient in Microsoft Office Suite.

• Extensive hands-on experience with Veeva Vault PromoMats, including workflow management, reporting, and promotional material lifecycle management (required).

• Experience with Digital Asset Management platforms, such as Aprimo, is preferred.

• Capability to read and interpret promotional materials and grasp the technical aspects of print production and digital media.

• Proficiency in writing comprehensive reports and detailed business correspondence.

• Ability to train large groups when necessary.

• Basic math skills and understanding of specification sheets.

• Problem-solving skills using semi-standardized solutions that require creativity and analysis.

• Ability to draw conclusions and follow prescribed, detailed procedures for addressing moderately complex problems.

• Periodic travel may be necessary.

• Must demonstrate proactivity, meet deadlines, multitask effectively, adapt to changes, function in a complex, fast-paced environment, and manage additional responsibilities.

🏝️ Benefits

• Competitive salaries.

• Comprehensive benefits package.

• Inclusive workplace environment.

• Reasonable accommodations for individuals with disabilities.

• Remote office work arrangement.