Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

JOB PURPOSE

Our team provides Legal support, inter alia, to Global Functions including Global Regulatory Affairs (“GRA”), Global Pharmacovigilance (“GPV”), and Global Medical Excellence governance team (within the Chief Medical Office (“CMO”) as well as global cross-functional committees involving these functions.

The primary mission of this position as joint Legal Business Partner to Global Regulatory Affairs (GRA) is to provide strategic legal advice to the GRA function (including but not limited to the Global Head of Regulatory Affairs and members of the Regulatory Affairs function worldwide) on drug and device safety and regulatory matters, supporting operational and governance strategies from a global perspective.

The secondary mission of the Legal Business Partner is to provide ad-hoc legal support as necessary to the Global Pharmacovigilance function, paying particular attention to risk management, safety procedures and SOPs, and strategic contractual support, namely in relation to key regulatory operations and partnerships. 

The lawyer shall

• Have experience in life sciences, in particular regulatory and health law, in relation to pharmaceuticals (Rx & OTC), medical devices, food supplements, and cosmetics at European and global level
• Provide strategic legal advice, actively support projects and contribute to the management of legal risks for the CMO, GRA and GPV perimeters
• Provide legal counselling in the context of product issues management for the entire Sanofi portfolio (Product Alerts, Quality Alerts, Product Crises), and assist in the coordination of certain product liability litigation.
• Advise clients on governance, data privacy, strategic and operational issues (updating, implementing, improving and harmonising procedures, policies, templates and guidelines)
• Have expertise in contract law, contribute to client functions’ contract and vendor selection strategy (assisting with the implementation of Master Services Agreements under Sanofi’s preferred vendor strategy, and direct and autonomous drafting and negotiation of preferred vendor contracts)
• Provide strategic legal advice in respect of transverse initiatives and transformation projects, involving organisational change and divestment projects impacting GRA and GPV regulated activities in addition to broader litigation risk faced by the Sanofi group
• Make recommendations regarding ways of working and liaise within legal and operational networks
• Monitor developments in regulatory & health law at EU level and their reflection in internal procedures and activities (pharmaceutical regulations, medical device regulations contract policy, e-signature, engagement with scientific experts etc.) and deliver legal and procedural awareness training to client and operational teams

KEY ACCOUNTABILITIES

Legal Advice

• As a Business Partner, support the Head of Legal, Chief Medical Office (CMO) & Regulatory in providing strategic legal advice and actively supporting projects within the scope of responsibilities. In particular, analyse legal risk and potential consequences, and propose strategic solutions facilitating innovative projects within various units and functions of the Sanofi group worldwide

Contractual Expertise

• Draft and negotiate key contracts, principally in English, and provide daily support to the business in the context of strategic provider and partner agreements

Governance

• Cooperate with and manage cross-functional teams the establishment maintenance, development and improvement of policies and procedures. Participate, as a core member, in global cross-functional management meetings and act as delegate of the Head of the CMO Legal team, as necessary

Working within a Network

• Interact and collaborate with operational teams, other support functions, and the different teams within the Sanofi Legal, Ethics and Business Integrity (LEBI) team (Global Business Units, Regions, R&D, Intellectual Property, Industrial Affairs, Data Privacy Office, Procurement and Ethics and Business Integrity etc.), with a view to coordinating legal activities and advice, and improve existing processes

Legal monitoring and Training

• Monitor legal developments within the scope of the mission and put into place awareness training and activities at operational level and assist with the recruitment and management of trainees within the team 

PROFILE REQUIRED

Knowledge, Skills, Abilities

This lawyer must

• Have significant expertise in life sciences laws and regulations at European and international levels and an excellent understanding of the pharmaceutical industry
• Have excellent interpersonal skills, ability to work as part of international, cross-functional teams
• Have excellent communication and negotiation skills, a high level of business acumen and sound judgment
• Be pragmatic, rigorous, proactive, able to produce high-quality legal advice in complex and time-sensitive situations
• Have expertise in advising on data privacy topics (with specific emphasis on healthcare data)
• Be fluent in legal English (verbal and written) 

Qualifications

• Education to level BAC+5 in Business Law and/or Pharmaceutical Law
• Min. 4-5 years of professional experience in an international organisation or law firm

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.