Job Title

Chez Roche, vous pouvez tre vous-mme et tre apprci pour les qualits uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, o vous tes valoris, accept et respect pour ce que vous tes, vous permettant de prosprer tant personnellement que professionnellement. Voici comment nous visons prvenir, arrter et gurir les maladies et garantir chacun l'accs aux soins de sant aujourd'hui et pour les gnrations venir. Rejoignez Roche, o chaque voix compte. La position The Opportunity We are looking for individuals with diverse experiences to enhance our capabilities at Roche and make a meaningful impact for patients. This role supports both Roche Pharma and Diagnostics by managing trial registration, results posting in line with US and EMA regulations, and ensuring document transparency through the redaction and public release of clinical study documents (e.g., CSRs, protocols) as required by EMA, Health Canada, and FDA regulations, as well as the Roche Data Sharing Policy. Partnering with internal stakeholders, this role ensures compliance with regulatory requirements while safeguarding Personal Protected Data (PPD) and Company Confidential Information (CCI). The Disclosure Specialist will also engage with Health Authorities and Affiliates to set appropriate disclosure levels and actively participate in industry groups to stay informed and influence emerging regulatory developments. Lead accurate and timely posting of Genentech and Roche clinical trial protocols and study results on public trial registration websites such as ClinicalTrials.gov and the EU results registry. Identify studies requiring registry and results postings, ensuring responsible PDR management and staff are informed of timelines, deadlines, and requirements. Liaise with project teams and affiliates to ensure they understand their regulatory disclosure responsibilities. Submit protocol documents for registry entry preparation and quality control checks to ensure consistency within the registry, protocol, and across franchises. Collaborate with cross-functional team members to acquire data, reviews, and approvals needed to complete registry and results entries on internal and external websites. Monitor workflows for registry and results entries to ensure they are completed on time and meet objectives. Manage document and data uploads in applicable systems, while tracking correspondence with cross-functional teams to ensure timely responses. Who you are Possess a degree in Life Sciences (or equivalent) with at least 5 years of relevant experience, and a proven ability to independently lead complex molecule and molecule-enabling projects. Demonstrated experience in leading cross-functional teams, generating insights, and working effectively in a matrix-based, global environment with strong interpersonal and communication skills. Solid understanding of the drug development process, relevant regulations (e.g., clinical trial disclosure, GxP, GCP), and working knowledge of multidisciplinary functions such as clinical development, clinical operations, and biostatistics. Proficiency in computer skills, including Microsoft Office Suite (Word, PowerPoint, Excel) and Adobe Acrobat, with fluency in English (both verbal and written). Previous experience in regulatory affairs or other product development functions is preferred, along with the ability and willingness to travel as needed. Relocation benefits are not available for this position Qui nous sommes Un avenir plus sain nous pousse innover. Ensemble, plus de 100 000 employs travers le monde sont ddis faire progresser la science et garantir chacun l'accs aux soins de sant aujourd'hui et pour les gnrations venir. Nos efforts aboutissent plus de 26 millions de personnes traites avec nos mdicaments et plus de 30 milliards de tests raliss avec nos produits de Diagnostique. Nous nous encourageons mutuellement explorer de nouvelles possibilits, favoriser la crativit et conserver nos grandes ambitions, afin de fournir des solutions de sant qui changent des vies et ont un impact mondial. Construisons ensemble un avenir plus sain. Roche est un employeur offrant l'quit en matire d'emploi. #J-18808-Ljbffr