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Director Clinical Affairs
Job Opportunity at
Summit Search Consultants.com
Posted on Nov 6
New Orleans, LA
Our client is an equal opportunity employer and headquartered out of New Orleans, Louisiana. They encompass a wide variety of services including Toxicology, Pharmacogenetics, Wellness Testing and more.
We are seeking a Director of Medical Affairs. This role will be responsible for achieving and maintaining compliance with all regulatory entities, and thus ensuring safe and high quality clinical testing services. The position oversees all of the workflows for individual testing services, individual competency and performance of technologists and analysts and the quality control monitors active in these workflows.
The Director of Medical Affairs is a direct liaison with clients and regulatory agents for issues related to clinical testing services.
There will be 8-12 direct reports working under this individual.
Required Experience & Skills
MD with subspecialty board certification in anatomic pathology and molecular genetic pathology (American Board of Pathology).
Minimum of 3 years experience as a surgical pathologist and medical director for a certified clinical laboratory performing histopathologic review and high-complexity testing.
Minimum of 3 years of management experience.
Demonstrable experience in formal document generation and control related to compliance with clinical testing regulatory agencies (CLIA, CAP, etc.)
Detailed knowledge of CLIA and/or CAP regulatory guidelines and inspection preparedness.
Review, edit, and attest to all documents required for regulatory compliance (CLIA, CAP, and/or specific state agencies)
Develop, implement and maintain a Quality Management Program that includes quality controls, workflow monitors, assay and analytics validations, proficiency testing and self inspection program management, process improvement, program management, laboratory safety and ergonomics.
?Professional communications with clients, potential clients, ordering physicians, partner laboratory personnel, regulatory agency officials, and organization staff and leadership regarding clinical testing services.
Corredination with lab operational leadership to anticipate and mitigate problems arising in any production workflow (crisis management).
Review and interpretation of clinical data including sign-off of clinical patient reports.
Participation in production and delivery of presentations that communicate the medical and clinical laboratory mission, accomplishments, scientific and/or clinical publications, and new products and service goals.
Assist with managed care applications and credentialing when requested.
Represent the organization at local, regional and national conferences upon request.
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