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Job Title: Risk Evaluation and Mitigation Strategies (REMS) Manager
Location: REMOTE

Job Description:
The REMS manager will provide operational support for the delivery of Risk Evaluation and Mitigation Strategies (REMS) for the safety epidemiology and risk management group. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program.

ROLES AND RESPONSIBILITIES

• Support delivery of REMS activities to agreed timelines according to AstraZeneca quality standards and REMS procedures.
• Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program
• Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members
• Manage REMS specific issues and escalations, as applicable
• Coordinate regular team meetings; track outstanding action items and activities per the project plan
• Help manage and reconcile contracts, POs and invoices
• Support REMS processes and procedures with execution of key deliverables

ESSENTIAL
• Bachelor’s degree (preferably in medical or biological science) or equivalent by experience.
• At least 5-7 years of relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance
• Previous demonstration of basic project management skills including tracking deliverables
• Strong communication skills and fluency in English
• Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data
• Detail oriented and
• Proficient in Microsoft applications
• Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP (Good [x] Practice) environment

DESIRABLE
• Prior REMS experience
• Project Management Certification
• Audit or Inspection experience Working with third-party vendors