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Clinical Disclosure Office Manager
hace 2 meses
Novartis Farmacéutica is seeking a highly skilled Clinical Disclosure Office Manager to join our team. As a key member of our organization, you will be responsible for ensuring quality and compliant protocol registrations and results postings, as well as alignment with global registries.
Key Responsibilities:- Participate in client trainings to drive quality and compliance and organizational alignment to changing disclosure requirements.
- Stay current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards.
- Independently represent Novartis to internal stakeholders and develop effective working relationships with global and country multidisciplinary leaders.
- Participate in the maintenance of Standard Operating Procedures and preparations for external & internal audits.
- Apply a continuous improvement mindset to ensure 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 EudraCT and the Citeline Disclose tool (also known as PharmaCM) 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. We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Division: Development
Business Unit: Innovative Medicines
Location: Spain
Site: Barcelona Gran Vía
Company / Legal Entity: ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
