This position will be responsible for monitoring regulations, laws and legislation at the federal, state and local levels to guide license applications through the regulatory approval process under the direction of the Director, Regulatory Affairs. Under direct supervision of the Director, Regulatory Affairs, takes a primary role in assisting in all aspects of regulatory compliance efforts and procedures. Acts as primary backup to the existing Licensing This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all corporate and regulatory requirements.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Monitors the overall compliance program at the operating level and works closely with the Director, Regulatory Affairs.
- Monitor regulations, laws and legislation at the federal, state and local levels.
- Accountable for compliance to state, local and federal regulations.
- Work with management to ensure that all activities are done in accordance with regulatory requirements.
- Develop, deploy and refine quality system policies and procedures to ensure continued adherence to changes in the regulatory environment.
- Provide support to all centers using electronic systems (e-SOP, Compliance Wire) for licensing requirements.
- Demonstrated ability to resolve routine issues, identifies non-routine issues, and proposes or takes actions to resolve them.
- Tracks and maintains records as per regulatory requirements.
- Participates in the investigation of compliance-related incidents, under the direction of the Director, Regulatory Affairs.
- Assists with the coordination of all training programs related to regulatory compliance to ensure compliance with corporate standards, as well as State and Federal laws and regulations.
- Prepares and maintains regulatory reporting.
- Operates, in conjunction with the Director, Regulatory Affairs, as liaison with Federal, State and local regulatory agencies.
- Manage and keep up to date Center licensing lists for Pharmacist and Pharmacy Technicians.
- Manage and keep up to date specific state reciprocal pharmacist license requirements to ensure each PharMEDium center is compliant.
- Provide back up support to the Licensing Specialist.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Requires training in regulated industry such as pharmaceuticals, or similar vocations generally obtained through completion of a Bachelor Degree program, technical vocational training, or equivalent combination of experience and education; normally requires two (2) to three (3) years directly related experience.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- BachelorDegree in science or related field is desired
- Knowledge of legal and regulatory compliance regulations
- Knowledge of Federal, State and local regulatory agencies
- Ability to communicate effectively both orally and in writing
- Strong technical background
- Good interpersonal skills
- Good mathematical skill
- Strong organizational skills; attention to detail
- Ability to follow and interpret government regulatory requirements and changes
- Minimum of 3 years Quality Operations experience
- Experience in a regulated facility is preferred (FDA, DEA, etc.).
- Must have uncompromising attention to detail, excellent analytic skills and the ability to effectively communicate to all levels of management.
- Good working knowledge of applicable regulations (GMP, FDA, DEA, etc.).
- Demonstrated strength in written and verbal communication, organization.
- Demonstrated ability to be detail oriented.
- Ability to work independently as well as within a team environment.
- Strong computer related skills (Microsoft suite including Excel, and Word).