Senior Disclosure Specialist, Global Regulatory Compliance
hace 1 día
The Senior Disclosure Specialist, Global Regulatory Compliance, is responsible for ensuring quality and compliant protocol registrations and results postings. This includes alignment with global registries, such as ClinicalTrials.Gov, EudraCT, and EUCTIS. The successful candidate will have oversight of these processes and be accountable for protocol registry and results eligibility assessment.
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 apply operational knowledge to ensure harmonization of Novartis transparency processes and standards.
- Represent Novartis to internal stakeholders, developing and maintaining effective working relationships with global and country multidisciplinary leaders.
- Maintain Standard Operating Procedures and prepare for external & internal audits.
- Apply a continuous improvement mindset, ensuring best practices are shared continually to drive 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 ClinicalTrials.Gov, EudraCT, and the Citeline Disclose tool (also known as PharmaCM) advantageous. Knowledge of drug development, writing protocols, 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.
What We Offer:We offer a competitive salary, estimated at $95,000 - $125,000 per year, depending on location and experience. Additionally, our benefits package includes opportunities for professional growth and development, a comprehensive health insurance plan, and access to our employee assistance program. If you're passionate about reimagining medicine and improving people's lives, we encourage you to apply.
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