Summary

Our client, a leading global bio products organization, is seeking an interim Medical Director for their corporate site based in Austin, TX.

Duties / Expectations of Role

• Supports the establishment of donor processing policy and SOPs including standards for acceptable vital signs, medical conditions and approval of donor medications.
• Provides clinical guidance to Medical Directors in the field related to the collection of source plasma with an emphasis on maintaining the health and safety of the donor in addition to the safety and efficacy of the plasma.
• Maintains high medical standards and ensures adherence to company SOPs, FDA, EU regulations and policies, and OSHA, CLIA and cGMP requirements throughout the donor collection process.
• Provides support for medical oversight and consultation for Medical Directors in the field
• Visit on-site clinics as needed.
• Provides training support to Medical Directors in the field regarding safe plasma donation and company SOPs.
• Reviews and approves guidelines for the Medical Specialist Training Program.
• Participates in review of the Guide for Donor and Unit Suitability.
• Provides guidance to Medical Specialists for donor eligibility in situations/medical conditions that are not specified in the Guide to Donor and Unit Suitability.
• Provides guidance to the Lookback Deviation Department regarding unit safety and suitability.
• Documents and generates Risk / Impact Assessment reports for reported plasma safety and quality incidents.
• Leads/participates in monthly meetings with the Center Medical Directors regarding policy/SOP changes, development of the source plasma industry expertise, in addition to provision of guidance regarding Medical Directors