Global Medical Lead, Rx to OTC Switch

Global Medical Lead, Rx to OTC Switch

Location:

Morristown, NJ

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. Leads initiatives that advance our brands and strengthen our reputation worldwide. Mentors and uplifts emerging talent while pushing your own growth and influence.

Embeds sustainability, access and social impact into every decision. Shapes a culture that’s ambitious, collaborative and serious about recognition and belonging.

• 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.

• 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.

The salary range for this position is: $ – $. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs.

Opella Inc. and its U.S. affiliates are Equal Opportunity and Affluent Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America applicants only.