Associate Manager, Global Patient Safety - Immunology & Inflammation

Role Summary

Associate Manager, Global Patient Safety - Immunology & Inflammation. Regeneron's Global Patient Safety Sciences team seeks an Associate Manager to support risk management activities, prepare periodic safety documents, and serve as an in-house subject matter resource for assigned therapeutic area programs.

Responsibilities

• Support Patient Safety Leads in risk management activities, including preparation of DSURs, PSURs, and RMPs, and conduct of safety signal activities.
• Act as in-house subject matter resource for identified areas within assigned Therapeutic Area programs.
• Monitor safety profiles of assigned compounds to identify safety signals and develop/evaluate plans for their assessment.
• Author regulatory documents for assigned compounds.
• Prepare and deliver presentations at SMT meetings; participate in Dose Escalation meetings.
• Participate in other risk management activities as appropriate for assigned compounds.
• May represent Risk Management on cross-functional teams (e.g., Regeneron Safety Oversight Committee, Independent Data Monitoring Committees) with external members.
• Contribute to development and maintenance of SOPs and supporting documents; participate in process improvement within PVRM.

Qualifications

• Required: Master‚Äôs Degree, PhD, or PharmD.
• Required: 3+ years‚Äô relevant experience.

Skills

• Ability to monitor safety signals and develop evaluation plans.
• Regulatory writing and document preparation.
• Effective communication and presentation skills for cross-functional teams.
• Experience with risk management activities and SOP development.

Education

• Master‚Äôs Degree, PhD, or PharmD (as above).

Additional Requirements

• Position may require on-site work; discuss location with recruiter.