RISK MANAGEMENT LEAD
A global biotechnology company is seeking to hire a Global Drug Safety Risk Management Lead for a year-long contract.
The Global Drug Safety Risk Management Lead will be responsible for: 1) Development of REMS, DRMP's & RMP's, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies. 2) Actively participates in Benefit- Risk Committees and other safety committees as needed as well as managing the Benefit-Risk process. 3) Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. 4) Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment. 5) Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports.
Duration: 12-month contract
Location: Cambridge, Massachusetts
Compensation: $78-85 per hour
- Education: MD, PhD, Pharm D, or Master's degree in a science or healthcare related discipline with specialty training in functional area.
- Must have 2-years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.
- Must have 3-years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products.
- Knowledge and active use of Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
- Ability to establish and maintain professional communication both internally and externally with all stakeholders.
Sthree US is acting as an Employment Business in relation to this vacancy.