Global Medical Lead Enterogermina (All Genders) Milano

Global Medical Lead Enterogermina (All Genders)
Milano
Lombardia, Milano

About the job_

The Global Medical Lead works within the cross-functional Opella Global Brand team and contributes to the development of the cross functional brand strategy.

Their key responsibility is the development and execution of the global medical strategy.

The Opella Global Medical Lead's main objectives are to:

- Contribute to the development of the global Opella Brand strategy.

- Be responsible for development and execution of the Brand medical strategy.

This includes scientific data generation publications, scientific engagement and technical document plans.

- Develop a key external expert network and establish relationships with relevant scientific organizations.

- Contribute to the design and the oversight of Clinical Studies and RWE studies.

- Contribute to the clinical part of Common Technical Document.

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.

This mission is brought to life by an 11, 000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.

Join us on our mission.

Health.

In your hands.

**Main responsibilities**:

- Globally responsible for strategic medical planning for Enterogermina as one of our 6 key global Brands for both Life Cycle Management as well as Innovation projects.

- Lead and oversee operational medical activities' execution in close cross-functional and global/local collaboration.

- Use professional & strategic capabilities to identify critical medical insights & use these to guide global Brand decision making.

- Ensure an external focus, including regular external interactions with key stakeholders, is prioritized as a key strategic & learning opportunity.

- Monitor & evaluate the implications of the evolving body of scientific evidence.

- Be the representative Medical Leader in the Global cross functional Brand team.

- Promote scientific innovation opportunities across the global, leverage medical/scientific knowledge to develop robust concepts.

- Clearly define the desired outcome(s) from prioritized activities defined in the medical strategy and define operational milestones to deliver on these medical commitments.

Key activities include:

- Developing medical insights, anticipate trends, identify & execute on science inspired innovation opportunities, product development, life cycle management, medical evaluation of Business Development opportunities, local switch opportunities, scientific endorsement & stakeholder management, risk mitigation.

Development of new claims built to on Brand goals.

**Design and Oversee Clinical Studies

- Be the strategic lead that identifies the need for evidence generation activities.

- Be the strategic lead in the development of clinical studies.

This includes providing medical expertise for the scientific content such as study strategy, oversight and approval of the protocol, Key Results Memo, Clinical Study Report and for other clinical development activities (e. g.

pre-assessment and cluster feasibility, medical review and validation of clinical data, study risk assessment).

- Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study teams and investigators.

- Act as the medical reference in the Clinical Study teams, ensuring the medical relevance of the clinical data.

**Common Technical Document (CTD)

- Coordinate the preparation of the clinical part of the CTD for FDA & EMA submission to ensure contribution will be provided timely (end to end: from kick off to the provision of the final version ready for submission).

- Provide medical expertise for the development of the Clinical part of the CTD.

**KEY WORKING RELATIONSHIPS

- Global Regulatory Affairs

- Pharmacovigilance

- Science Hub Regional Heads

- Scientific Engagement, Communication and Claims Team

- Clinical Operations Team

- RWE Team

- Global Medical Strategy and Operational Effectiveness Team

- Local Medical function

- R&D

- Growth Hub

- About you_

- **Experience**: Minimum of 5-8 years of experience in the pharmaceutical industry medical or scientific affairs are required, preferably both locally and