Rx to OTC Switch, Global Medical Lead

Opella; Morristown (AZ); Presencial; USD 152 000 - 219 000; Tempo integral

Resumo da oferta

Opella is seeking a Global Medical Lead to oversee Rx-to-OTC switch programs, guiding global medical strategy, regulatory input, and cross-functional collaboration with science, regulatory and commercial teams.

You will drive country strategies, engage KOLs, and lead publications while mentoring rising talent and reinforcing our commitment to sustainable, patient-centered self-care.

Qualificações

• Bachelor's Degree with 7+ years in clinical research with medical affairs experience; exposure to Rx‑to‑OTC switch programs and consumer studies preferred.
• Experience in clinical development and/or medical affairs, including contribution to regulatory submissions (e.g., NDA).
• Background in switch product development and global or regional roles.
• Experience leading clinical and consumer behavior studies relevant to OTC switch.
• Exposure to regulatory/advisory committee meetings and engagement with KOLs/SMEs.
• Proven ability to lead cross-functional projects with strong strategic and analytical skills.

Responsabilidades

• Lead and execute global medical strategies for Rx-to-OTC switch programs in partnership with cross-functional teams (science, regulatory, commercial)
• Serve as medical lead for clinical and behavioral studies (e.g., label comprehension, actual use), ensuring regulatory compliance and high-quality delivery
• Lead medical input into regulatory interactions and submissions, including health authority meetings and NDA documentation
• Develop and implement benefit-risk strategies and support regulatory maintenance activities (e.g., PSUR, RMP)
• Drive country/regional medical strategy execution aligned with global switch objectives and local market dynamics
• Lead external engagement (e.g., KOLs, advisory boards) and publication strategies to support program success
• Support pipeline growth through medical due diligence and insights on future Rx-to-OTC switch opportunities

Conhecimentos

Cross-functional leadership

Strategic thinking

Analytical skills

Stakeholder engagement

Leadership

Formação académica

Bachelor's degree in a relevant field

Descrição da oferta de emprego

Salary Range $151,500.00 - $218,833.33

All Compensation Will Be Determined Commensurate With Demonstrated Experience.

Global Medical Lead, Rx to OTC Switch
Location: Morristown, NJ

About The Job

• Leads global medical strategy for Rx‑to‑OTC switch programs, including regulatory input, insights, and due diligence for new assets, supporting both global and country/regional teams
• Drives execution of country-specific medical plans across development and lifecycle stages, collaborating cross‑functionally and aligning local roadmaps with global strategy
• Lead initiatives that advance our brands and strengthen our reputation worldwide.
• Mentor and uplift emerging talent while pushing your own growth and influence.
• Put purpose into practice — embedding sustainability, access and social impact into every decision.
• Model the challenger mindset: question complexity, act with integrity and make things radically simple.
• Help shape a culture that’s ambitious, collaborative and serious about recognition and belonging.

Main Responsibilities

• Lead and execute global medical strategies for Rx-to-OTC switch programs in partnership with cross-functional teams (science, regulatory, commercial)
• Serve as medical lead for clinical and behavioral studies (e.g., label comprehension, actual use), ensuring regulatory compliance and high-quality delivery
• Lead medical input into regulatory interactions and submissions, including health authority meetings and NDA documentation
• Develop and implement benefit-risk strategies and support regulatory maintenance activities (e.g., PSUR, RMP)
• Drive country/regional medical strategy execution aligned with global switch objectives and local market dynamics
• Lead external engagement (e.g., KOLs, advisory boards) and publication strategies to support program success
• Support pipeline growth through medical due diligence and insights on future Rx-to-OTC switch opportunities

About You

• Bachelor's Degree with 7+ years in clinical research with medical affairs experience; exposure to Rx‑to‑OTC switch programs and consumer studies preferred
• Experience in clinical development and/or medical affairs, including contribution to regulatory submissions (e.g., NDA)
• Background in switch product development and global or regional roles
• Experience leading clinical and consumer behavior studies relevant to OTC switch
• Exposure to regulatory/advisory committee meetings and engagement with KOLs/SMEs
• Proven ability to lead cross-functional projects with strong strategic and analytical skills
• Strong leadership, communication, and stakeholder engagement capabilities

This is more than the next step in your career, it’s a chance to lead change and help reinvent self‑care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you.

We are challengers. We are Opella.

Opella Inc. and its U.S. affiliates are Equal Opportunity and Affi…

About Us

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission is to bring health in people’s hands by making self‑care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.