Location. Chattanooga, Tennessee. Department Description. US CHC Medical department acts as a strategic catalyst to the CHC business to ensure the development and support of innovative consumer-friendly healthcare solutions; solutions based on actionable medical insights and utilization of credible scientific evidence. Through scientific engagement this department helps shape medical knowledge and clinical practice to provide better health outcomes and helps Sanofi achieve its mission of Empowering Life. . Provide clinical study monitoring and oversight, as well as Medical Affairs stewardship of the dermatology and oral health therapeutic area portfolios which includes pharmacologic and related non-pharmacological products. Main include provide oversight and monitoring of conducted clinical studies; assist with the generation of actionable scientific insights that lead to the development of credible product differentiation strategies for local brands; effectively collaborate to support scientific engagement and improved health outcomes; and provide medical support for the dermatology and oral health therapeutic area portfolios. . Assist with the generation of credible scientific evidence supporting product safety and differentiation, including coordination and monitoring of clinical study conduct, study product shipment and handling, data collection and analyses, study site management, collection and archiving of regulatory study documentation and the conduct of timely query generation and issue resolution. Work directly with the Clinical Research Organizations (CROs) to ensure the study is conducted in accordance with GCP principles and applicable regulatory and project timelines. Manage delivery of all study related documentation clinical study budgets and ensure timely CRO payments consistent with agreed upon milestone deliverables. Develop the medical interpretation of generated study data and assist with the dissemination of data interpretation, especially the generation of evidence-based product claims. Effective collaboration internally and externally to evolve scientific engagement and review medical accuracy of promotional and non-promotional materials and provide medical approval. Be the medical affairs representative in the cross-functional teams responsible the products assessed in the clinical studies. Assist with scientific innovation and development of promotional claims based on credible evidence and actionable medical insights. Enhance effective self-care and improved consumer health outcomes by assisting with the promotion and development of creative, evidence-based, consumer-oriented solutions. Basic Qualifications. Bachelor s degree in a health care related field from an accredited college. ACRP or SOCRA certification. In-depth knowledge and understanding of clinical drug development, pharmacovigilance, risk benefit assessment, FDA regulatory framework for pharmacological products and promotional product claims, and ICH/GCP and GDP guidelines. At least 2 years of experience managing all aspects of clinical trial design, implementation and reporting. Preferred Qualifications. Ability to work effectively with clinical investigators and other research personnel, maintaining a professional demeanor. Excellent organizational and time management skills. Function effectively with high degree of personal accountability. Proficient with electronic software such as Outlook and Microsoft Word, Excel and PowerPoint. Effective collaborator (cross functionally, horizontally, vertically) with a strategic and future-forward attitude. Terms of employment. UP to 40% national travel is required for this position. The hired candidate will report to the US CHC Medical Head Dermatology, Oral Health and Product Safety. Benefits of working in this role . This role provides the opportunity to work with and learn from multiple departments representing numerous aspects of the business, thus providing enriching insight into the complex Sanofi OTC organization. With strong achievements and contributions resulting from the outcomes of actionable medical insights, opportunities to take on additional roles can lead to a progression within the Medical organization. This role is intended for an aspiring leader who can be independent, creative, decisive and driven to achieve strong scientific outcomes. The rewards of those contributions are measured in the achievements seen by adding to the growth potential of the company and the opportunity to lead and shape a dynamic department. Sanofi US Services, 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. #CHC. 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. 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.
21 Jan, 2019