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Regulatory Assistants are responsible for collaborating with team members for the regular maintenance of Porzio Compliance Sciences, LLC’s (“PCS”) products and the performance of compliance services. A Regulatory Assistant on the Licensing Team provides support to deliver quality state filings / applications required to obtain and/or maintain distribution licenses necessary to ship and/or sell drug/device and other life sciences-related product. Responsibilities include assistance with product maintenance, quality control and compliance projects. Other responsibilities may include research, development of professional presentations, and involvement in the marketing of PCS products and services. Regulatory Assistants perform their duties under the direct supervision of Regulatory Analysts, Supervisors and Managers of Quality Control Services, Managers and Directors of Compliance Services, the Executive Vice-President, and other PCS personnel in the delivery of life sciences marketing and sales compliance services.
Job Responsibility:
Provide general clerical support, including filing, indexing, and copying
Assist team with quality control of product content, including reviewing and revising customer state filings and deliverables
Collaborate with team members to assist with the delivery of premium customer service
Communicate with various state agencies and professional licensing boards
Draft general correspondence and status updates
Assist in performing factual and regulatory research
Assist in locating pertinent pending legislation related to various areas of life sciences marketing and sales compliance
Assist in monitoring and tracking multiple deadlines and due dates
Become proficient at time-keeping
Develop project management skills
Proficiency on all applicable computer and web-based programs
Proficiency in using equipment including, but not limited to, telephones, photocopy machines, and computers
Perform other work-related duties as assigned
Requirements:
Bachelor’s degree required
Ability to master the factual, regulatory and technological aspects of subject matter area
Strong verbal, written, analytical, organizational and interpersonal skills
Ability to prioritize tasks and meet tight deadlines
Flexibility in daily work schedule to meet company needs during periods of heavy workload
Flexibility in schedule to travel on company-related business
A valid driver's license and ability to transport oneself to off-site project locations independent of mass transit