Location: Morristown, NJ

Grade: L4
Hiring Manager: Charles Pollack

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. 

About the job:

The Global Switch Medical Lead is responsible for leading, managing and contributing to the global medical science switch strategies, insights and deliverables to meet the needs of the country-specific/regional teams. In addition, provides support to the Global Switch Team and cross-functional teams on medical science aspects, including assessing potential new switch assets (i.e., due diligence assessments).

This role involves developing and executing medical science strategies for country-specific switch programs at both development and life cycle management stages, interacting with cross-functional team members, and collaborating with internal and key external stakeholders. The individual will also be responsible for defining and executing the country/regional-specific medical roadmaps in alignment with the local and global switch strategies. Reports to the Global Medical Strategy Lead. Works with the project team(s) in helping drive the medical strategies.

The ideal candidate is experienced with medical science knowledge and advanced science degree. They should be experienced in clinical research including development and execution of clinical and behavioral trials, with demonstrated ability to work in a matrix environment and implementation of operational medical science excellence.  The individual must have extensive knowledge and proven experience in preparing regulatory submission documents for switch programs. Knowledge and experience outside the US are desired.

Main Responsibilities:

• Lead and manage the development and execution of medical science strategies for switch programs in partnership with science, regulatory and commercial project team leads.

• Responsible for collaboration with external experts, with leadership in execution and management of activities related to project-level advisory boards meetings.

• Serve as medical lead for the development, execution, interpretation and reporting of clinical and consumer behavior studies (e.g., Human Factor, Label Comprehension, Self-selection, Actual Use Trials), compliant with GCP  and regulatory requirements.

• Serve as medical lead in Health Authority Meetings including contribution and review of regulatory submission documents (e.g., meeting briefing package).

• Serve as medical lead in Health Authority Meetings including contribution and review of regulatory submission documents (e.g., meeting briefing package).

• Lead medical/clinically relevant country/regional-specific switch project benefit-risk mitigation strategies with evidence generation to support timely and successful regulatory outcomes.

• Leverage understanding of country/regional-specific consumer & patient journeys to identify strengths, weaknesses, threats and opportunities for successful switch programs.

• Lead medical/clinically relevant country/regional-specific switch project benefit-risk mitigation strategies with evidence generation to support  timely and successful regulatory outcomes.

• Contribute medical science strategies to innovation pipeline and lead medical due diligence of future Rx to OTC switch molecules in partnership with science, regulatory and commercial along with other switch functions.

• Understand and leverage Rx to OTC Switch d