Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description

The Medical Director determines donor eligibility based on applicable standards, regulations and established policies.

Responsibilities:

• Conducts review of medical records, gathers additional donor’s screening information as needed and determines final donor eligibility.
• Advice, training and provides feedback to Tissue Services staff on medical conditions necessary for the proper execution of their duties.
• Reviews and approves policies/questions requiring medical input if needed.
• Using outside symposia, medical literature and professional medical forums, stays current with medical issues and education related to donor eligibility criteria.
• As appropriate, conducts training of QA, RA, and Tissue Services staff on medical issues related to the evaluation of donor eligibility
• Ability to comprehend donor charts and make medical judgments and determinations with a high degree of accuracy.
• Continually makes assessments on the adequacy for medical file information and understands how to effectively challenge as needed data and gather additional data if required
• Establishes and maintains donor eligibility criteria and policies consistent with standards and regulations.
• Acts as a liaison between the Tissue Services Team and the Tissue Recovery Partners
• Serves as a medical SME during process and procedure improvements
• Performs risk assessments on human tissue complaints or other quality records
• Serve as a team member, and approver, in the development of Health Hazard Evaluations (HHE’s).
• Review product complaints as applicable
• Ensures that established goals and objectives are met.

Qualifications

Requirements:

• Medical Doctor degree required.
• 7-10 years of experience in clinical practice, research, or teaching.
• Licensed to practice medicine. Licensed to practice medicine in New Jersey required.
• Board Certified preferred or at least 7-10 years of clinical practice experience
• Leadership/management experience in running and/or mentoring a team is highly desirable.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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