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 busi