Clinical Disclosure Manager
hace 4 semanas
This role is with Novartis, an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community.
About the RoleThe Manager, Clinical Disclosure Office ensures the quality and compliance of protocol registrations and results postings, as well as alignment with global registries (e.g. Clinical Trials.Gov, Eudra CT, EUCTIS, Novartis Clinical Trial Results EMA-HMA Catalogue of non-interventional studies, etc.) with oversight.
Key Responsibilities:- Participate in client trainings within Biomedical Research and Novartis Pharmaceuticals to drive quality and compliance and organizational alignment to changing disclosure requirements.
- Responsible for staying current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards.
- Independently represent Novartis to internal stakeholders.
- Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.S, Legal, and Business Development & Licensing.
- Participate in the maintenance of Standard Operating Procedures and preparations for external & internal audits.
- Apply a continuous improvement mind set ensuring best practices are shared continually driving to the most productive processes.
- Bachelor's degree in a scientific discipline preferred.
- Minimum 3 years pharmaceutical industry experience with knowledge in disclosure including registration, maintenance, and results disclosure.
- Experience with Clinical Trials.Gov, Eudra CT and the Citeline Disclose tool (also known as Pharma CM) advantageous.
- Knowledge of drug development, experience in writing protocols, experience in multiple clinical indications and/or therapy areas desired.
- Proven development skills in a responsible position within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs or related areas.
- Ability to successfully work within complex cross divisional matrix; previous experience leading multidisciplinary teams in matrix environment.
- Strong negotiation & conflict resolution skills; well organized, focused on results/compliance, strong planning, tracking, problem solving and decision making skills.
- Proficiency in Good Clinical Practice, Regulatory Processes and clinical trial designs.
- Ability to adapt to changing external environment.
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
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