RA Licensing Supervisor
Fresenius Medical Care, Waltham, MA
(Full time)

Division:  Corporate

An outstanding opportunity to work at Fresenius Medical Care North America. Fresenius is the world's largest, integrated provider of products and services for individuals with chronic kidney failure, a condition that affects more than 1,300,000 individuals worldwide. Through its network of over 49,000 employees in over 100 countries, FMCNA offers outstanding career opportunities across the globe in a rapidly expanding yet stable environment . Working at Fresenius means growing your career while making a difference.

Description
 

Receive, review and provide information on license applications forwarded from the DC Managers and/or various state and federal authorities.
Responsible for completing and managing the submissions of initial and renewal license applications to Boards of Pharmacy and other state agencies and authorities.
Responsible for gathering, and reviewing all required pertinent information regarding all submissions and ensures that all information is accurate prior to final review by Department Manager.
Research and record all new state regulations pertaining to the movement of Drugs/Devices and staying current on new regulations that will impact the business of shipping FMCNA product.
Provide ongoing advice and oversight to FMCNA Customer Service(Pharmacy Protocol) in relation to the distribution of products to clinics, hospitals, wholesalers and home patients. Designated as the Regulatory Affairs approval authority for all SOPs related to this function.
Provide outside suppliers with current applicable licenses.
Maintain Regulatory Affairs Licensing Department files.
Provide appropriate information to support licensing requirements.
Assist Manager with all License Compliance Strategy and Development.
Provides coaching, counseling and advice to direct reports. Provides feedback to employees on a consistent basis. Works with employees to develop clear and concise development plans to ensure the advancement of future leaders within Regulatory. Responsible for the annual assessment for all direct report employees, utilizing the companys performance management tools.
Update and provide all appropriate internal contacts with monthly licensing status reports.
Provides guidance and advice to Sr. Licensing Specialist.
Special projects may also be assigned on an as-needed basis.
Other duties as assigned.

Requirements
 

BS in scientific or legal discipline preferred
Pharmacy license preferred
AS in Paralegal Studies and/or Paralegal Certification highly desirable.
Pharmacy Technician Certificate and/or CPhT. utilized in the hospital or clinic field; Pharma Degree strongly preferred. 8+ years general business experience preferably in the life sciences, pharmaceutical, biotechnology or the medical drug/device industry.
An advanced understanding of federal and state Pharmacy Regulations is required for this role.
Must be capable of working independently; demonstrate attention to detail, professional, highly skilled at prioritizing, multitasking and organizing.
Must be able to meet goals on time, be a team player and have excellent written and verbal communication skills.
Familiarity of medical terminology.
Fresenius offers highly a competitive benefits package that includes medical and dental, 401k, short- and long-term disability, tuition reimbursement, and a paid time off program. Fresenius Medical Care is an Equal Opportunity Employer. For more information please visit our website at www.fmcna.com. Please apply on-line at www.fmcna.com.
 
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( AllHealthcareJobs Job ID:604807 last updated on 11/30/2009)


        
         

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