Global Risk Management Plan Manager
hace 2 semanas
**Job Summary**
We are seeking a highly skilled Global Risk Management Plan Manager to join our team at the Healthcare Businesswomen'S Association. The successful candidate will be responsible for managing and coordinating the development of Safety Risk Management Plans (RMPs) to ensure regulatory compliance and high-quality documents.
Key Responsibilities
- Manage the development of RMPs, including tracking commitments and liaising with relevant functions.
- Support the Global Product Safety Leader (GPSL) and designated medical writer in the preparation and finalization of high-quality RMPs.
- Coordinate activities across different line units to ensure all documents required to support the RMP main document are included in the RMP annexes.
- Manage logistical aspects related to the timely development of safety RMP annexes and work with authors to ensure content meets Novartis and Health Authorities (HA) requirements.
- Review RMPs to ensure consistency and regulatory compliance of RMP sections and annexes.
- Track HA feedback and assessment on RMP and ensure HA requirements are implemented as required.
Requirements
- At least 5 years of experience in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.
- Proven ability to work with large cross-functional teams in complex projects.
- Demonstrated teamwork and effective communication skills.
- Knowledge of worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.
- Proven ability to interpret and discuss efficacy and safety data relating to multiple therapeutic areas.
Preferred Qualifications
- Advanced degree (Masters, PharmD or PhD) desirable.
- Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) is desirable.
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Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completoAbout the RoleThe Global Risk Management Plan Manager plays a critical role in ensuring the timely preparation, development, and finalization of high-quality and regulatory-compliant Safety Risk Management Plans (RMP). This position requires strong collaboration and communication skills to work effectively with cross-functional teams, including medical...
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Barcelona, Barcelona, España Novartis A tiempo completoJob DescriptionJob Summary: We are seeking a highly skilled Global Risk Management Plan Manager to join our team at Novartis. The successful candidate will be responsible for providing support to medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans.Key Responsibilities:Develop and...
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