? High Salary! Clinical Documentation Global Head
Company: Sanofi
Location: Cambridge
Posted on: July 8, 2025
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Job Description:
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. GD-SA LI-SA LI-Hybrid vhd 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.
Keywords: Sanofi, Waltham , ? High Salary! Clinical Documentation Global Head, Accounting, Auditing , Cambridge, Massachusetts
