Real-World Evidence and Switch Engagement Lead, North America

Location

Bridgewater, NJ | United States

Job description

Responsibilities

Real World Evidence & Switch Engagement Lead, North America

Remote Work: Hybrid

Travel Expected: 10% (domestic)

About The Job

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our Team:

Reporting to the Head of Real-World Evidence (RWE), Behavioral Science and Data Platforms, the North America (NA) RWE Engagement Lead will be directly responsible for the development and execution of comprehensive strategic RWE roadmaps for the NA and Switch teams that directly address unmet scientific and business needs through delivery of science-based consumer evidence. The incumbent will be responsible for coordinating with other cross-functional leads including Medical, Regulatory, R&D, and Commercial in addressing a variety of business needs through RWE and Behavioral Science.

The North America RWE Engagement Lead will also ensure successful execution of the studies by collaborating with other members of the RWE, Behavioral Science and Data Platforms team on the study design and working with external partners on the delivery of evidence. Furthermore, this role will also be responsible ensuring proper translation and simplification of the science to resonate with the consumer in line with the overall brand strategy through scientific publications, consumer claims, and other digital channels.

Main responsibilities:

The RWE Engagement Lead will:

• serve as a key strategic advisor on RWE both externally with the FDA and other regulatory agencies, as well as internally with NA and Switch senior stakeholders.
• be responsible for furthering the adoption of RWE for Consumer Healthcare within the NA region and partner with other RWE Engagement Leads on pursuing that mission globally
• work with the Data and Analytics team on cultivating new consumer-friendly data sources within NA and continue to push consumer-driven studies and strategies both internally to Senior and Executive Leadership and externally with health authorities and industry associations.

Knowledge and Skills:

• Proven track record of real-world evidence strategy development and execution across a broad range of study designs including prospective, cross-sectional, and retrospective with a focus on patient/consumer meaningfulness.
• Experience with a wide variety of behavioral science methodologies (ethnographies, diary studies, usage studies, in depth qualitative, etc.) and an understanding of the applicability and context of each study’s inherent strengths and weaknesses.
• Demonstrated experience translating unmet needs and research questions into strategic roadmaps and meaningful study designs within longer term evidence generation plans.

Oversight, Coordination, Execution & Delivery:

• Facilitate the strategic planning process for real-world studies with North America and Switch medical leads and cross-functional colleagues by identifying data gaps and evidence needs that are aligned with the priorities and strategic plans for medical and GBU.
• Autonomously execute strategic roadmaps for Switches and North America region through end-to-end delivery of high-quality RWE that meets overall timelines and budgets in line with brand and Switch strategies.
• Serve as the primary contact for real-world evidence expertise internally within the North America and Rx to OTC Switch teams, as well as externally in engagements with the FDA and other regulatory/health authorities, industry associations, etc.
• Inform the feasibility of RWE based study options and the evolving role of RWE based scientific evidence for internal and external (e.g. regulatory) needs.
• Identify relevant data sources and develop partnerships to utilize high impact and quality data sources within their respective region and lead the identification of emerging data sources, platforms, and scientific methodologies in the industry.
• Implement best practices and innovation in RWE and proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, and efficiency.
• Ensure compliance with the GBU governance processes such as the study review committee (SRC). Lead the development of study outlines and relevant materials for facilitating SRC reviews.
• Embed appropriate scientific methodologies in observational research and statistical analyses at level that is aligned with the strategic requirements ranging from internal needs to high-quality regulatory grade evidence.
• Ability to proactively identify and anticipate study risks and propose action plans to mitigate impacts in study delivery.

Communication

• Superb communication skills in simplifying science, multi-stakeholder presentation experience, comprehensive understanding of business needs, and highly evolved capability in translating RWE based medical studies to diverse audiences.
• Lead and/or coordinate the development of scientific publications and presentations at professional congresses that communicate the findings from RWE and take leadership positions in external industry associations influencing the adoption of RWE within North America
• Strong English skills (verbal and written if English is the second language) i.e., ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication.

Collaboration with partners

• Ability to work cross functionally, ability to be flexible and adapt effectively to a variety of individuals in an international environment with internal and/or external partners.
• Experience in the development of external relationships including management of vendors for outsourced activities, cultivating academic and other industry partnerships, etc.

Technical Knowledge

• In-depth knowledge of various real-world and behavioral study methodologies, as well as applicability of the methodologies according to their strengths and limitations to address various unmet needs.
• Familiarity with the FDA and other regulatory guidelines as it relates to real-world evidence adoption and utilization for Rx to OTC Switches, NDA guidelines, etc.

About You

Experience :

• Expertise in developing strategic, evidence-based roadmaps based on relevant real world and behavioral science methodologies, including basic epidemiological methods, retrospective studies (administrative claims, EMR, patient registry), prospective observational study design, as well as ethnographic, usage, and other behaviorally focused methodologies.
• Previous experience engaging with FDA and other health authorities on RWE/Behavioral Science results and/or methodologies.
• Demonstrated leadership at a senior level and excellent networking, influencing, and communication skills.
• Experience in Consumer Healthcare (CHC) is highly desirable.

Soft skills :

• Strategic mindset, self-driven

Technical skills :

• Proficient in Microsoft Office products required;
• R, SAS is a plus

Education :

• Advanced science degree (MD, PhD, MSc, MPH) in relevant health or science discipline.

Languages:

• Fluent spoken and written English

Pursue Progress, Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

#LI-SA

#GD-SA

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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