Contract Center Medical Director/Center Physician Position Available In Jefferson, Alabama

Job Description:

1. Serves as the primary physician for reporting to the Food andDrug Administration and in such capacity provides medical oversightin compliance with applicable Federal and State regulationsincluding the applicable sections of Title 21 of the Code ofFederal Regulations and monitors medical compliance of thecenter.2. Either serves as or delegates to another appropriatephysician the duties of “laboratory director”, “technicalconsultant”, or “clinical consultant” as prescribed by the ClinicalLaboratory Improvement Act of 1988 regulations (CLIA). Assures that

CLIA/COLA

training, CLIA/COLA proficiency testing for hematocritand total protein, and signed of logs involving standardizationtakes place.3. Reviews, understands, and complies with all CSLPlasma Services policies and procedures in the performance ofservices. Maintains high medical standards and ensures that cGMPsare adhered to through involvement with center management, centerquality unit, and overall center activities. Is physically presentat the center for agreed upon hours.4. Provides medical oversightto Medical Staff Associates, including their training, althoughsuch training may be delegated to an approved Medical StaffAssociate. Trains other physicians. Evaluates newly trained MedicalStaff Associates for completion of training and recommendation forcertification by Regulatory Affairs. Functionally directs theCenter Medical Staff. Provides training to other center staff onmedically related procedures and practices.5. Reviews and signedMedical Staff Associates notebooks weekly, including a review ofapproximately one out of five screening medical evaluations andunsuitable test result communications.6. Meets with Medical StaffAssociates at least once a month to discuss medically relatedtopics. Documents each meeting. Meets with the Center Manager andCompliance Specialist (or designees) during weekly visits to thecenter. Serves as a member of the Quality Assurance Team. Acts as aliaison between the Corporate or Divisional Medical Director andthe Center Medical Staff, which includes preparation of monthlyreports and periodic conference calls.7. Responds to questions andphone calls regarding donor suitability for long-term serialplasmapheresis. Responds to calls from and provides instruction toCenter Medical Staff with donorsuitability questions. Conductsconfidential and effective interviews with donors to obtaininformation ina variety of situations. Interviews donors withpositive STS/negative FTA and documents approval toresumedonating.8. Maintains confidentiality with respect to employee,donor and center records reviewed during thecourse of all duties.

Responsible for overseeing maintenance of medical supplies ad otheremergencyequipment.9. Reviews and sings moderate and severe medicalincident reports prior to donor being permitted toresume donating.

Reviews abnormal test results including abnormal serum proteinelectrophoresis (SPE)test results and donor recordfiles. Reviewsnormal SPE test results following an abnormal one and documentsapproval to resumedonating.10. Assures the health and safety ofdonors participating in the non-red blood cellimmunizationprograms, if applicable. Monitors donor clinicalresponse to immunizations, when applicable. Overseeshyper-immuneprograms, if applicable.11. For red cell recipients in the Anti-DProgram, if applicable: Performs qualifying evaluation(e.g.administers consents, medical history and physical exam) ondonors before enrollment; provides reviewand approval for red bloodcell immunization; is present when red cell immunizations aregiven. Submitsmonthly report to Divisional (or Corporate) MedicalDirector.12. Determines donor suitability following adversereactions in consultation with the Corporate orDivisional MedicalDirector. Maintains current knowledge of infectious disease markets(i.e. HIV, HBV,HCV, syphilis, etc.)13. May perform Center Physicianfunctions including but not limited to notifying donors ofunsuitabletest results, performing screening medical evaluations,assessing results of donor screening andlaboratory tests todetermine a donor’s initial and continued suitability forplasmapheresis, explaininginformed consent materials to donors.14.Performs additional services as and when requested by thecompany.

EducationMD or DO degree from an accredited medical orosteopathic school

• Must maintain a current and active medicallicense in the state in which the Center is locatedExperience
• -One year of residency training as an MD or ODAdditional Comments
• -Familiarity with Code of Federal Regulations (CFR) and all relevantprocedures in the company Plasma Operating ProceduresWorkingConditions(physical & mental requirements
• Ability to makedecisions which have significant impact on the department’screditability, operations and services
• Ability to formulatecomplex and comprehensive materials such as authoritative reportsof major scope and impact, etc. and/or to make formalpresentations
• Frequently exposed to hazardous chemicals, extremetemperatures and to blood borne pathogens
• Required to wearPersonal Protective Equipment while performing specific tasks or incertain areas
• Overnight travel required up to 75% of the timewithout lengthy lead-time
• Frequent standing and walking
• Fastpaced environment with frequent interruptions CSL is introducing anew Career Framework, which will provide a common, globalinfrastructure for managing jobs and serve as a foundation forfuture career development and competitive rewards.

Certaincomponents of this job description, including Title and Level aresubject to change relative to applicable local laws. Your TalentAcquisition Consultant will discuss the pending changes withyou.

Our BenefitsWe encourage you to make your well-being apriority. It’s important and so are you. Learn more about how wecare at CSL.About CSL PlasmaCSL Plasma is one of the world’slargest collectors of human plasma. Our work helps to ensure thatpeople with rare and serious diseases are able to live normal,healthy lives. We are committed to our work because lives depend onus. Learn more about CSL Plasma.

We want CSL to reflect the worldaround usAs a global organization with employees in 35+ countries,CSL embraces diversity and inclusion. Learn more about Diversity &Inclusion at CSL.Do work that matters at CSL Plasma!