Senior Disclosure Protocol Manager

hace 2 semanas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
About the Role

We are seeking a highly skilled and experienced Senior Disclosure Protocol Manager to join our team at Novartis Farmacéutica. As a key member of our Clinical Disclosure Office, you will be responsible for ensuring quality and compliant protocol registrations and results postings.

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 mindset ensuring best practices are shared continually driving to the most productive processes.

In this role, you will have the opportunity to work on complex cross-divisional projects, lead multidisciplinary teams, and develop strong negotiation & conflict resolution skills. You will also have the chance to contribute to the development of clinical trial protocols, data management, project management, medical writing, regulatory affairs, or related areas.

Requirements

To be successful in this role, you will need a Bachelor's degree in a scientific discipline and a minimum of 3 years pharmaceutical industry experience with knowledge in disclosure including registration, maintenance, and results disclosure. Experience with ClinicalTrials.gov, EudraCT, and the Citeline Disclose tool (also known as PharmaCM) is advantageous. You should also have proven development skills in a responsible position within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs or related areas.

Benefits

At Novartis Farmacéutica, we offer a competitive salary range of $120,000 - $180,000 per year, depending on experience. Additionally, you will receive a comprehensive benefits package, including health insurance, retirement plan, and paid time off. We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.



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