Length: 6-month contract w/ extension possibilities
Location: FULLY REMOTE
Department: Clinical Safety
Role: Clinical Safety Risk Management Manager
The Clinical Safety Risk Management Manager is responsible for supporting global project teams on issues related to RMPs (risk management plans) and REMS (risk evaluation and mitigation strategies).
Key Responsibilities:
- Own and maintain the process for creating core RMPs (risk management plans)
- Oversee and support different teams on tracking submissions (and following status of submission)
- Guides and supports with alignment of RMPs, labels in key regions, as well as periodic reports
- Act as the SME on risk management and maintain knowledge of industry trends related to risk management
- Draft and review SOPs/SOIs related to risk management
- Collaborate and communicate with cross-functional teams to be aware of any gaps in RM planning, creation, and execution
Qualifications:
- Minimum of 2 years of relevant industry experience with project management and risk management
- Results-oriented, respecting people & values, partnership & collaboration, results orientation
- Excellent interpersonal, organizational, and multi-tasking skills
- PharmD, RN, PhD education required
*W2 BASIS ONLY