Pharmacy Regulatory Assurance Associate

CITY: Princeton STATE: New Jersey COUNTRY: USA Essential Functions (Responsibilities):
* Assist with the submission (typing, copying etc.), filing & maintenance of licenses, registrations & permits in accordance with local & federal requirements for GE Healthcare pharmacies, & drug distribution licenses for mnfg sites. Ensure all permits reflect current organization & operations at GE Healthcare facilities. Agencies for which licenses, registrations & permits are required include state boards of pharmacy, Nuclear Regulatory Commission, state departments of health & radiation protection, state DOT, & local waste management agencies. Act as liaison with Pharmacy Operations in the licensing process. Maintain all license files current for each facility.
* Assist with monitoring of local & federal regulatory agenda, in the areas of nuclear safety, transportation, boards of pharmacy, & hazardous waste, to identify the impact on pharmacy operations.
* In support of the Director PRA, facilitate arrangements for the Pharmacy RSO Conference. Prepare the agenda with input by the Director PRA & compile all training & conference materials for distribution.
* Assist in the maintenance of a system for the collection of investigational reports concerning incidents, misadministrations, regulatory inspections, enforcement activities, RSA audit reports & replies, monthly reports, & Safety Clearance documents. Compile & report other data, including environmental & hazardous waste disposal, as well as provide support to regional personnel.
* Assist in the preparation of the annual HSE report for the pharmacies. Obtain the necessary data and other information in the format required by Group HSE. Include any discussion of relevant issues provided by the Manager of PRA.
* Obtain & compile employee dosimetry results & ensure they are updated regularly. Alert Director PRA & site RSO's of any anomalies concerning results & investigate the status of any missing data. Complete & provide trending & summary reports based on established criteria.


Qualifications/Requirements:
* Associate's Degree and three years experience in support of nuclear pharmacy operations OR minimum five years experience in support of nuclear pharmacy operations.
* Strong demonstrated writing skills, articulating complex ideas in an easy to understand manner
* Must be willing to take a drug test
* Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
* Must be willing to work in an office located in Princeton, New Jersey
* Must be legally authorized to work in the United States


Desired:
* Bachelor's degree in a Physical Science, Biological Science, Radiological Health, Nuclear Pharmacy, Occupational Health & Safety or Environmental Science
* Thorough knowledge of nuclear pharmacy practices and operations.
* Knowledge of the Nuclear and HSE regulations affecting nuclear pharmacy operations.
* Excellent, effective oral communication skills
* The ability to recognize and address licensing liabilities and knowledge of the processes and systems used to correct and manage these.
* Ability to establish priorities and reach closure on important issues in a timely manner
* Ability to accurately record and assess detailed information
* Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
* Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
* Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

General:
The individual in the Pharmacy Regulatory Assurance Associate role will be responsible for activities to support the management of all licenses, applications, registrations, amendments and permits for GE Healthcare pharmacies and Corporate Offices in North America. The individual will be responsible for assisting in the management of drug distribution licenses for manufacturing sites. This role also involves the coordination of activities related to the documentation of data or information for compliance or as required by company Global HSE standards along with activities related to the internal audit program, RSO conference, dosimetry, inspections and other aspects of Pharmacy Regulatory Assurance Department.


We offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer.