Senior Director, RA Advertising and Promotions

Viatris • Washington, DC

1d • $151,000 - $314,000

About The Position

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here’s how the Senior Director, RA Advertising and Promotions will make an impact: The Senior Director, Advertising and Promotion Regulatory Affairs will be responsible for the development of regulatory strategies for promotion and advertising plans for the U.S. that align with the commercial brand plan in their assigned area. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Requirements

• Minimum of a Bachelor's degree (or equivalent) and relevant industry experience required. A degree in a scientific discipline is strongly preferred.
• A minimum of 5 years of experience in Regulatory Affairs with subject matter expertise in Ad Promo. However, a combination of experience and/or education will be taken into consideration.
• Must possess expert knowledge of regulatory guidance pertaining to advertising, promotion for pharmaceutical products.
• Strong knowledge of regulatory environment and FDA.
• Must possess excellent analytical, written and verbal communication, interpersonal, and project management skills.
• Must possess a strong work ethic and have outstanding organization and time management skills.
• Must have strong computer skills and be proficient within the Microsoft Office Suite.
• Position functions autonomously.
• Responsibilities may include interviewing, hiring, and training employees; planning, addressing complaints and resolving problems.

Nice To Haves

• An advanced degree (MS, PharmD, MD) in a scientific discipline is a plus

Responsibilities

• Providing strategic leadership and oversight to Advertising & Promotion (Ad Promo) activities within the assigned therapeutic area on advertising and promotion regulatory issues.
• Provide regulatory expertise as it relates to U.S. regulations for advertising and promotion of a prescription product on Commercial activities, including marketing strategies, marketing materials, training materials and other information used with external customers that could be impacted by these regulations.
• Provide regulatory expertise as it relates to U.S. regulations for advertising and promotion of a prescription product on Medical Affairs activities, including Medical strategies, materials and other information used with external customers by Medical Affairs personnel that could be impacted by these regulations.
• Acts as the Regulatory Ad Promo subject matter expert on product launch materials and strategies though identification of issues and bring solutions to resolve those issues.
• Identify areas for development of efficiencies for Advertising & Promotion process for the Promotional Review Process and Medical Review processes.
• Communicates/negotiates directly with the OPDP on advertising and promotional material on requests for advisory comments.
• Maintain effective partnerships with internal business stakeholders including, but not limited to Global Regulatory Leaders, Medical Affairs, Product Safety, Legal, Marketing, and Business Development to shape Ad Prom strategies.
• Review and comment on marketing materials intended for internal or external audiences that would be impacted by advertising and promotion regulations.
• Contributes to development of the prescribing information and provide feedback on updates to the product prescribing information.
• Provides training on advertising and promotion regulations to key stakeholders.
• Remains current on FDA regulations and guidance associated with advertising, promotion, and regulatory applications.
• Demonstrates role specific competencies and company values on a consistent basis.
• Perform other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level