Biomat USA, Inc. Hiring for Division Medical Director at Reading Full Time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

This is a remote based position that will include travel

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.

• 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 audit reports 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.

Education and Experience

• 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. CPR is required. Automated External Defibrillator (AED) preferred.

• Typically requires 5 years of related experience.

• 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.

• Performs Clinical Laboratory Improvement Amendments (CLIA) related Laboratory Director duties as needed.

Education and Experience

• Medical Degree (MD or DO). Current, unrestricted physician license. xa0Licensing in multiple states may be required. xa0 u2022 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. CPR is required. Automated External Defibrillator (AED) preferred.xa0n

• Typically requires 5 years of related experience.n

• Expertise in the medical field, and up to date with medical literature, medications and medical conditions. xa0Knowledge of current cGMP and SOPs, Ferderal and State regulations as they relate to biologics. xa0Excellent oral and written communication skills. xa0Must have excellent ability to multi-task, organize work, and prioritize competing demands. xa0Must be able to work independently and with little supervision. xa0Strong quantitative and analytical skills. Strong critical thinking and problem solving skills. xa0Ability to analyze and intepret data, identify errors and prepare reports. xa0Must be able to assess and trouble shoot problems, adapt to multiple changes, last minute requests, and manage highly educated individuals remotely. xa0Ability to relate and interact with a diverse population with heterogeneous social and educational backgrounds. xa0n

• Performs Clinical Laboratory Improvement Amendments (CLIA) related Laboratory Director duties as needed.nnn

EEO Minorities/Females/Disability/Veterans

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Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols

Req ID: 484947

Type: Indefinido tiempo completo

Job Category: Medical Affairs