Sanofi Group Clinical Trial Disclosure / Transparency Manager in Bridgewater, New Jersey
The Clinical Trial Disclosure / Transparency Manager (TTM) is a key member of the global Trial Transparency team in the Clinical Documentation department, CSO Platform. The TTM is responsible for overseeing or carrying out operations which together result in timely and complete disclosure of Sanofi trial information on publically accessible websites. Trial Transparency deliverables will meet the disclosure requirements of Health Agencies, Industry Associations, and the Sanofi company transparency commitments, all of which evolve regularly.
Drives the processes for assigned portfolio/s of disclosure activity (eg, therapeutic or regulatory area/s, vendor coordination) that result in timely, high-quality information posted on public websites, tracked appropriately
Works with study and/or project teams, ie, clinical, biostatistics, regulatory, marketing, patents and legal, to plan and prepare registrations and/or results for varied websites, according to current guidelines
Brings specialized knowledge of global disclosure requirements and standards to teams, in association with a scientific background, providing guidance on best practices to ensure quality of information shared publically, and compliance with defined requirements
Drives a strong focus in teams and partners on consistency of trial/product information across disclosures and associated areas such as publications and data-sharing
Provides careful oversight of activities managed in collaboration with Vendor partners
Understands data-sharing requirements and their relationship to trial disclosure
Due to the rapidly evolving nature of the disclosure landscape, leverages self-study, ongoing learning, etc. to remain abreast of developments in trial disclosure and related fields
Works effectively with disclosure and disclosure relevant tools used by the Platform
Depending on experience, may mentor more junior staff members and provide SME representation in varied disclosure-related projects both internal and transversal
Participate in or lead process improvement initiatives for disclosure
Bachelors’ degree in life sciences
3-5 years of experience in disclosure
Experience preparing clinical regulatory documents and/or experience in summarizing scientific information
Understand global regulatory requirements for clinical trial disclosure
Has working knowledge and familiarity with ClinicalTrials.gov and EudraCT
Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
Detail-oriented with excellent inter-personal and communication skills.
Ability to work effectively with a document management system and planning and tracking system.
Ability to work both independently and collaboratively with a team in a cross-cultural and geographically dispersed environment.
Excellent written and spoken English
Strong communication skills and ability to deliver clear messages to varied audiences
Demonstrated leadership, problem-solving, ability to work simultaneously on multiple projects, and ability to prioritize tasks
Proficiency with Microsoft Word, Excel, Power Point, and other Office applications
Advanced degree (e.g., Masters or Ph.D. in life sciences)
Specific knowledge of company-targeted therapeutic area/s is strongly desirable.
Familiarity with applied biostatistics
Experience working on Sharepoint
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.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life