Our Team:

This is a Governance role to support Managed Access Programs (MAP), Cross-GBU Pre-Registration Import License (PRIL) and Humanitarian Operations.

Managed Access Programs (MAP) help patients with serious or life-threatening conditions have access to investigational treatments when they don’t respond or tolerate approved therapies and when they are not eligible to participate in a clinical trial. Cross-GBU Pre-Registration Import License (PRIL) is designed to oversee temporary authorization and importation of a product allowing patients with medical needs earlier access to treatment. Humanitarian programs provide treatment to patients with specific illnesses where treatment access is limited.

Global Senior Manager – Governance & Risk Management sits within Specialty Care MAP and Cross-GBU PRIL Operations, and its mission is to ensure that medical Early Access Programs (EAP) of MAP & PRIL & Humanitarian operations will reliably achieve their business objectives, address uncertainty and act with integrity and meet industry, country & global standards, provides a unified approach to help manage governance and compliance risks, help stakeholders make accurate decisions, achieve principled performance and ensure a common understanding of communication, policies, and training.  

Main Responsibilities:

Governance

Build an effective cohesive governance framework that integrates EAP business activities with governance components to serve the changing business and regulatory environment.

Learn about the context, values, and culture of the company to define clear governance goals and actions to reliably achieve organizational objectives. Stay updated about various regulatory changes that affect the business.

Implement an effective governance strategy and revision with continuous evaluation and improvement to ensure consistent and effective governance development implementation& control to achieve business goals by bringing different parts of business into a unified and simplified governance framework.

Lead change management and Provide insights through MAP & PRIL & Humanitarian governance internal and external engagement reports that guide business to make accurate decisions in a fast-changing business environment.

Engage in internal and external medical governance related events and discussions as GBU governance business representative for MAP & PRIL & Humanitarian

Lead MAP & PRIL & Humanitarian governance revision, maintenance, improvements, simplification, and implementation at GBU level

Identify governance gap, perform risk assessment, mange & mitigate risks, identify and mange deviation, define escalation process, and implement solutions in alignment with stakeholders and business partners.

Represent Specialty Care in cross-GBUs, cross-functional governance projects around Early Access Programs (EAP) as the GBU governance business owner for MAP, PRIL & Humanitarian

Responsible for provision and implementation of governance related to GBU alliance business partners.

Lead Specialty Care Medical Quality Meetings with GBU Medical Quality Business Partner meetings

Ensure the success of governance implementation by seamless transparent communication between governance teams, stakeholders, and teams to make activities like creating process, planning, and decision-making easier. 

Risk Management

Define a risk management program to predict potential problems and minimize losses.

Assess different types of risks, including business, financial, legal, strategic, and compliance risks respective to MAP, PRIL & Humanitarian programs, propose risk minimization strategy, and define risk mitigation tactics and ensure implementation.

Accountable for GBU data and Knowledge management ensuring effective version of governance quality documents document are in use and proactively communication to end users of upcoming changes to ensure all end users have easy access to effective reference governance documents, and resources.

Governance Performance Compliance

Ensure MAP, PRIL & Humanitarian processes follow company’s pre-defined and established rules and internal corporate policies and procedures and countries relevant laws & regulations and ensure that EAP business activities comply with the respective company policies & procedures and country regulations.

Make data-driven decisions while setting up rules or frameworks and ensures development of responsible operations and streamlines operations around a common culture that promotes ethical values and creates a healthy environment for business growth.

Take actions that bring results and support business goals and monitor operations to detect and manage sudden changes or deviation.

improve process and data security measures to protect customer data and private information and ensure MAP, PRIL & Humanitarian comply with data privacy regulations like the General Data Protection Regulation and internal policies and procedures to help build customer trust and protect business from penalties. Keep self and stakeholders updated with data privacy and protection regulatory.

Perform continuous gap assessment in consideration of evolving regulatory & legal regulations and support business continuity while ensuring EAP remains fully compliant and aligned with applicable regulations, policies, and SOPs in close partnership with quality audit, internal audit, internal control, Data Privacy, CMO and other corporate & GBU functions.

Evaluate the results of governance activities in the GBU by running internal audits, compare actual performance with governance goals, decide if the governance framework is effective and make necessary improvements. Simplify and increase the accuracy of internal auditing. Accountable for CAPA resolution following an audit or inspection and act as focal point of contact for audit & quality and set clear roles and responsibilities for remediation and timely CAPA closure. Ensure audit & inspection readiness.

Interaction:

Work in close collaboration with Other GBU Medical Operations and Governance Teams, Global functions, and business partners, CMO, Medical, Market Access, E&BI, Legal, Data privacy, Internal Control & Process, Internal Audit, Medical Quality, Digital, Development TA, GPT, CSO, Procurement, GRA, PV, PTA

Contribute to GBU medical, Regulator, Market Access, discussion when a governance component is addressed. Present and/or prepare presentations on governance for reporting to senior leadership and or other relevant internal decision-making bodies.

About You

Experience:

• 10+ years in the biopharmaceutical industry expanding roles in Medical or Medical Operations Governance related field including experience, business acumen and understanding of the current pharmaceutical environment, with advance capability to manage complex projects, ability to successfully bridge between different fields of expertise, and managing program risks and challenges (including scenario and contingency planning).

• Strong knowledge of drug development process, regulatory and business requirements related to EAP programs management.

• Significant experience in Medical Governance, Medical Quality, Pharmacovigilance, Regulatory Affairs, Medical Operations (at global and affiliate levels) or Medical Excellence, with deep understanding of EAP operations

• Role model Sanofi Leadership Frame

• Strategic thinking: ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities.

• Result orientation: driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues.

• Leadership: ability to lead through influence, inspire teams, engage, and leverage everyone’s strengths. Set high standards and expectations, communicate proactively, collaboratively, and approachable and ability to provide meaningful feedback, coaching and support.

• Relationships and Influence: ability to empower and recognize others to create powerful relationships and networks. Effective stakeholder management, politically astute and role model teamwork and collaboration

Soft skills:

• Advance facilitation skills.

• Strong interpersonal communication skills (in English, written and verbal), able to communicate effectively across organization as well as with senior leadership.

• Well organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities, self-management.

• Excellent project management expertise with demonstrated leadership in managing complex sensitive projects.

Technical Skills:

Proficiency in applying Project Management tools, Quality Management tool (QualiPSO), Quality Document Management System (QDMS) PowerPoint, Smartsheet, PowerBI, and iEnvision with highly advanced presentation skills.

Education:

Bachelor’s degree, post graduate degree in scientific discipline (PhD, PharmD, MD) or related scientific degree.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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.

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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.