LATAM PARTNER MARKETS SENIOR OVERSIGHT LEAD - [HS-087]

Sanofi


Mission & Tasks The LATAM Partner Market Senior Oversight Lead is a key role who is responsible of ensuring operation and performance excellence of Medical and Regulatory activities managed by the LATAM Partner Markets, with the highest ethical and scientific standards, in accordance with relevant laws and regulations, and in compliance with Sanofi standards and CHC SOP’s. This role will work directly with the LATAM Partner Market Medical & Regulatory Leads with the objective of ensuring that an effective oversight is given to CROs and Distributors performing Medical and Regulatory activities along with a proper interaction with internal stakeholders (Quality, PV, Regulatory, Medical & Business Functions) for an efficient collaboration as a cross-functional team following the relevant governance framework model and ways of working. In addition, the LATAM Partner Market Senior Oversight Lead will support CHC business needs & will also be responsible of ensuring metrics/KPIs are in place and monitored for Medical and regulatory. - Key Contributions & Activities The LATAM Partner Market Senior Oversight Lead will: - Develop oversight procedures for the LATAM Partner Market aligned with the defined governance framework. - Monitor compliance of Medical & Regulatory Affairs agreement with CROs/Distributors with support of the LATAM Partner Markets Medical & Regulatory Leads. - Ensure metrics/KPI are in place and monitored to make sure the execution of Medical and Regulatory activities is performed, and appropriate actions are taken and implemented in LATAM Partner Markets. - Ensure proper screening for Risks (medical & regulatory) and development of Risk Management initiatives for those identified proactively or retrospectively. - Contribute to transversal projects impacting Partner Markets (e.g. systems, regulatory policy and intelligence projects, country position paper on regulatory topics, any other transversal projects). - Drive the identification of process optimization/improvement initiatives along with its adoption within medical & regulatory activities in LATAM Partner Markets including readiness for audits and inspection. - Foster an environment/culture of learning and sharing of best practice within the team. Required skills and Experience - Graduate degree - Scientific/health related degree (e.g. MD, PhD, Pharm.D.) - Scientific background with extensive experience in medical/regulatory affairs in Pharmaceuticals - Knowledge of consumer healthcare/pharmaceutical industry standards and practices for medical/regulatory affairs domains in LATAM countries - Fluent spoken and written English & Spanish - Project management skills At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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