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Years of Experience
ProfileDirector of Regulatory Affairs and Risk Management The candidate will overall responsibility to ensure that the pharmacy subsidiaries of ABD Group Inc. remain compliant with all laws and regulations that are applicable. In addition,will be responsible for advising senior management on risk management issues including but not limited to business insurances, human resource matters and contracts. Responsible for accessing the expertise of both in-house and external resources (i.e. legal counsel) to help advise and support on risk management issues. In conjunction with clinical leadership, interprets regulatory rules or rule changes and ensures they are communicated through corporate policies and procedures. Maintain a current knowledge base of existing and emerging regulations, standards or guidance documents and recommends changes to company procedures in response to changes in regulations or standards. Coordinate and document internal regulatory processes, such as internal audits and inspections. Tracks all current legislation/regulations applicable to the pharmacies including federal, state, and state boards of pharmacy. Serves as the primary contact for all relevant governmental regulatory agencies. Implements new requirements by ensuring that all personnel affected are trained and educated of the changes and that written policies and procedures are either developed or edited to reflect the same. Ensures that contractors implement changes as applicable. Ensures that open lines of communication are maintained so that all personnel may report potential issues of non-compliance without retaliation. Conducts internal monitoring and auditing to ensure compliance with legal requirements. Conducts prompt investigations and corrective actions when it is determined that non-compliance has occurred. Oversees Prescription Monitoring Program reporting. Business insurance policies including the adequacy of coverage and renewal applications. Review of contracts with payors, manufacturers, wholesalers and other parties to help management manage risk via contracting efforts. Assists with RFPs and applications – especially as it relates to potential contract language. Provides support and review in support of Human Resources including contract review and research on employment matters. Works to increase licensure footprint of the pharmacies by reviewing and submitting new license applications. Monitors license renewal dates and executes renewal applications. Compiles and submits materials to all regulatory agencies. Ensures that all current licenses are posted in the pharmacy as required by law.
Qualification and Experience
The candidate should have Bachelor's Degree; 5+ years of experience working as Paralegal or Legal Assistant (J.D. education may substitute for years of experience). Must be detail orientated and have the ability to stay organized and maintain priorities in a fast-paced work environment. Should preferably have Juris Doctor Degree, Paralegal Certificate and experience working at law practice as legal assistant or paralegal, experience working in pharmacy or healthcare setting and working knowledge of pharmacy law.
Note : This is a temporary position.
Village Fertility Pharmacy
335 Bear Hill Road
Waltham, MA 02451