Lead Specialist, PRC Operations

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $66k - $127k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

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Viatris

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Healthcare • Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Drive the US PRC approval process for assigned therapeutic areas under the US VMAP SOP • Apply FDA regulations and Viatris policies to promotional material review • Liaise with and guide marketing agencies and document owners on PRC submission standards and processes • Lead and facilitate cross-functional PRC meetings, including agendas, discussion management, documentation, and follow-up • Partner with Medical, Regulatory, Legal, and Marketing reviewers to resolve comments and maintain PRC timelines • Coordinate end-to-end PRC operational activities for new product launches, including planning, prioritization, resources, and readiness tracking • Manage communications among PRC stakeholders on marketing operations and cross-functional initiatives • Direct and oversee contractors supporting PRC activities, including assignments, prioritization, workload, deliverables, and feedback • Plan and prioritize PRC workloads, identify capacity constraints and scheduling conflicts, and recommend adjustments • Develop continuous-improvement work groups for VMAP, lifecycle management, demand generation, and product marketing programs • Partner with marketing, advertising agencies, and external partners to complete promotional materials for regulatory submissions • Support submission, review, approval, activation, deployment, utilization, and expiration/destruction of educational and commercial assets • Author and execute initiatives to optimize Marketing Operations processes, structure, and reporting • Build and capture monthly metrics and KPI reporting • Manage department training schedules and content; assist with Veeva Vault and VMAP training • Serve as subject matter expert for the VMAP process and Veeva system • Provide senior operational guidance, coaching, and expertise to PRC team members; support onboarding and knowledge sharing • Perform other related duties as assigned

🎯 Requirements

• Minimum of a bachelor’s degree (or equivalent) and minimum of 6-8 years of experience; a combination of experience and/or education will be taken into consideration • One to three years of pharmaceutical experience and/or project management strongly preferred • People management experience preferred • Knowledge of FDA regulations and Viatris policies governing promotional material review • Knowledge of promotional review, approval, and material production/digital processes • Knowledge of 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 • Strong background in process and project management • Experience working with vendors and holding them accountable to timelines and budget • Working knowledge of Microsoft Office Suite • Strong 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, preferred • 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 • Ability to train large groups if required • Basic Math skills and ability to understand spec sheets • Ability to solve problems using semi-standardized solutions requiring ingenuity and analysis • Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems • Periodic travel required • Must be proactive, meet deadlines, multitask, adapt to change, operate in a complex, fast-paced environment, and handle additional responsibilities

🏖️ Benefits

• Competitive salaries • Benefits • Inclusive environment • Reasonable accommodations for individuals with disabilities • Remote Office work arrangement

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