Reporting to the Chief Medical Officer, will support the medical department of the assigned donor centers and the Grifols Plasma Operations. This includes assessment and mentoring of the Center Medical Directors, coaching and training of the center medical staff, providing medical guidance and oversight to the donor selection process, and collaborate with the Operations, Quality and Training teams of their assigned centers. This role also includes supporting and delivering training and development programs for the medical staff and the Grifols Academy of Plasmapheresis, as well as working on improvement projects for the medical operations of the Donor Center Network.
Primary Responsibilities for the Role:
● Be available (in person, phone, email or fax) for consultation with the center staff, center physicians and Division Management team for their assigned donor centers during those centers' hours of operations.
● Be readily familiar with Current Good Manufacturing Practices (cGMP) training, current State and Federal guidelines, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and pertinent sections of the Code of Federal Regulations (CFR).
● Be readily familiar with the approved Standard Operating Procedures for all the donor center platforms of Grifols Plasma Operations.
● Be readily familiar with company procedures and pertinent regulations that relate to all aspects the medical department at the donor center level.
● Maintain current, unrestricted medical licensure, possibly in multiple states, and knowledge of the plasma industry.
● Provides medical support and guidance to donor center medical staff of all centers within designated region. Each region includes multiple geographically distinct plasma centers throughout the United States. Manages the Center Medical Directors of each center.
● Provides medical oversight and guidance, based on the Corporate procedures of the Medical Department, in order to maintain a homogeneous approach to the donor selection process across the company.
● Acts as a liaison between Chief Medical Officer and Center Medical Directors to improve communication between the center level medical staff to corporate medical department in each center from designated regions.
● Directs, coaches, develops and guides Center Medical Directors. Conducts monthly call with Center Medical Directors.
● Responsible for working together with the center and divisional management team for the proper training, certification, and annual recertification of the Center Medical and Laboratory Directors in their Division.
● Works together with the center and divisional team to implement medical policies and procedures at the center level.
● Evaluate donor incident reports generated at the donor center to assess for sound medical management and proper documentation.
● Trained and certified in all the functions of a center medical director, and in the specialty programs for any given donor center.
● Review internal and external auditreports for their respective donor centers to discuss with the corresponding center Medical Director and identify areas needing improvement.
● Be aware and may assist the Center Medical and Laboratory Director, as well as management teams of their assigned donor centers, in the development and implementation of corrective action plans in matters pertaining to the medical department.
● Assist the Chief Medical Officer with the editing and review of medical procedures for the Standard Operating Procedure (SOP) and the Medical Reference Manual as well as Corporate training programs, education materials and quality improvement projects for the medical department.
● Provides training to all levels of center staff thru teleconferencing and/or hands on training, as required.
● Serve as a back-up for all the duties of the Center Medical and Laboratory Director for his/her donor centers or other centers as directed by the Chief Medical Officer.
● Serve as a back-up for other Division Medical Director, as needed.
● Regularly communicates with the Chief Medical Officer and provides a monthly written report with a review of the medical department of his/her assigned donor centers, as well as an assessment of the medical operations for each of such centers.
● Conduct activities in a responsible and ethical manner according to accepted medical standards to ensure donor safety and product safety.
● Conduct activities in accordance with Grifols' history, values and mission to ensure donor safety and product safety.
● Prepares project specific documentation to reflect methods used with details to support comprehension and replication of the analysis.
● May collaborate as instructor of the Grifols Academy of Plasmapheresis.
● Recommend changes and improvements to the Standard Operating Procedures.
● Acts as Center Physician at plasma center by consulting with the donor center staff regarding donor suitability issues; reviewing medical incident reports; assisting in the training of physician substitutes; performing regular review of their outputs to include donor physical examinations and logs. Manages the review and signing of all 4-month charts to include protein electrophoresis and Rapid Plasma Reagin (RPR) testing.
● Assists the department as needed with other duties as assigned.
Performs Clinical Laboratory Improvement Amendments (CLIA) related Laboratory Director duties as needed. Laboratory Practice.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
EDUCATION: Medical Degree (MD or DO). Current, unrestricted physician license. Licensing in multiple states may be required. • Evidence of fulfillment of CLIA requirements as Director of a Laboratory of Moderate Complexity by either documentation of completion of specialty training in Pathology or Hematology or documentation of completion of 20 hours of Medical Education Course in Laboratory Practice.
EXPERIENCE: Typically requires 5 years of related experience.
EQUIVALENCY: Skill, competency and performance as Center Medical Director, as well as prior experience in a leadership position may be considered in place of the stated requirements. For example: a physician who has demonstrated excellent control of the medical operations of the donor center, or a physician who has also managed a medical clinic, a team in an urgent care or similar setting, or other applicable leadership experience, may be considered in lieu of 5 years of experience in the plasma industry. These cases are evaluated and approved exclusively by the Chief Medical Officer.
KNOWLEDGE, SKILLS, & ABILITIES: Expertise in the medical field, and up to date with medical literature, medications and medical conditions. Knowledge of current cGMP and SOPs, Federal and State regulations as they relate to biologics. Excellent oral and written communication skills. Must have excellent ability to multi-task, organize work, and prioritize competing demands. Must be able to work independently and with little supervision. Strong quantitative and analytical skills. Strong critical thinking and problem solving skills. Ability to analyze and interpret data, identify errors and prepare reports. Must be able to assess and trouble shoot problems, adapt to multiple changes, last minute requests, and manage highly educated individuals remotely. Ability to relate and interact with a diverse population with heterogeneous social and educational backgrounds.