Clinical Documentation Global Head

Job Title : Clinical Documentation Global Head

Location : Cambridge, MA, Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Clinical Documentation Head is responsible for the leadership and oversight of a team of functions heads, team managers, experts, and professionals in charge of the delivery of clinical documents and dossiers for filing drug applications (IND, CTA, NDA, BLA, MAA and variations) to the Health Authorities in all regions, inspection readiness and clinical trial disclosure.

The Head of Clinical Documentation is accountable for the development of document management strategies and flawless execution of Clinical Documentation deliverables.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities :

He / she contributes to the development of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets.

He / she : Creates and executes a long-term vision and forward-thinking capabilities across all domains and geographies of Clinical Documentation including Medical Writing, Document Management, Trial Transparency, Translations and Record Management.

Utilizes creative, thoughtful and boundary-pushing strategies, and performs risk analysis, to propose and lead organizational and process transformations to simplify and accelerate the delivery of quality dossiers to Health Authorities in alignment with sanofi strategy and priority portfolio. He / she is a source of innovative ideas and unlocks opportunities, implements and monitors KPIs.

Develops and implements scalable and sustainable sourcing strategies (In / Out sourcing, Internal / external hubs) and capabilities of value to drive operational efficiencies and ensure business continuity. He / she optimizes budgets and identify opportunities for cost savings in alignment with strategic business plans.

Fosters collaboration with external stakeholders, and between clinical documentation teams, and oversees the people and services delivery.

Partners with Digital to lead the development of strategic technology direction. He / she enables the development of innovations and features to increase productivity, deliver business value and return on investment while serving system users.

Perform market intelligence reviews to identify opportunities and maintain extensive knowledge of key drivers pertaining to dossier management. Maintain an environment of compliance aligned with regulatory requirements and best-in-class industry standards.

Provide strong leadership and leverage expertise to create an environment of trust that fosters participative management and continuous open communication that facilitate knowledge sharing, collection of feedback and efficiency gain from lessons learned.

Inspires, develops, and engages a world-wide highly efficient team of managers. Promotes a culture of accountability to attain and sustain performance and operational excellence.

Partners with People and Culture to drive the evolution of the organization ensuring skills evolution to meet new business needs and digitalization challenges.

About You

Knowledge And Skills :

Strong interpersonal skills and entrepreneurial mindset.

Proactive, forward thinker with creative and solutions-mindset

Strong demonstrated leadership skills, capacity to work across matrix organizations

Ability to make strategic plans based on cost and performance analysis and ability to evaluate strategic implications of transformations.

Passion for building cost efficient organizations, processes and technologies.

Analytical abilities and problem-solving skills. Demonstrated ability to analyze needs, generate and assess options, and facilitate the choosing of best fit solutions

At ease with risk management and business continuity planning.

Agility to navigate in nimble environments.

At ease with agile methodologies and ability to execute lean and iterative approaches

Build effective relationships, use diplomacy, value people. Ability to distil key information from various sources and present information in a positive way.

Strong ability to inspire and motivate cross-functional, multidisciplinary teams

Formal Education And / Or Experience Required :

PhD / Master degree in scientific discipline, PharmD, or medically qualified with :

Min 15 years of experience working in clinical development and / or regulatory affairs

Min 10 years of leading an internationally dispersed organization managing budgets, planning and staffing.

Experience in developing value strategies and implementing vision, understanding of finance and performance management principles, familiarity with diverse business functions such as finance, procurement, legal, digital….

In depth knowledge of strategic partnership and governance implementation, as well as third parties management.

Experience with innovation project implementation and change management

Knowledge And Skills Desirable But Not Essential

Excellent knowledge of Sanofi processes and Digital landscape related to drug development.

Knowledge of innovation technologies relating to content and document management (e.g. content re-use and artificial intelligence)

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.