Clinical Documentation Global Head

New Yesterday

Job Title: Clinical Documentation Global Head 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. He/she contributes to the development of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. * 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. 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. Partners with Digital to lead the development of strategic technology direction. 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. * Promotes a culture of accountability to attain and sustain performance and operational excellence. * Proactive, forward thinker with creative and solutions-mindset * 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. * At ease with risk management and business continuity planning. * At ease with agile methodologies and ability to execute lean and iterative approaches * 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 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) 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. marital, domestic partnership or civil union status; disability; veteran or military status or liability for military status; domestic violence victim status;
Location:
Morristown