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Our Regulatory & Compliance Specialists are responsible for supporting and collaborating with our legal team of Partners, Attorneys, Directors, Paralegals and Regulatory & Compliance Specialist in the firm’s mission to expertly, efficiently and expeditiously provide our clients with the highest quality of legal, regulatory and compliance services.
The Regulatory & Compliance Specialist responsibilities; include, but are not limited to working on legal, regulatory and compliance matters, such as:
•Monitoring and Auditing;
•Federal and State Aggregate Spend Compliance and Reporting;
•FDA and State Regulatory Filings (including, regulatory intelligence, regulatory strategy and risk management);
•Domestic and International Compliance;
•Development, Creation and Implementation of Standard Operating Policies;
•Legal-Medical-Regulatory Promotional Material Review; and
•Developing, Creating and Facilitating Training and Educational Presentations.
Other duties include:
•Significant client interaction and travel (up to 80 %);
•Managing large and complicated projects; and
•Other tasks as dictated by Partners, Attorneys, Directors, Paralegals, and Regulatory & Compliance Specialists.
CANDIDATE REQUIREMENTS & QUALIFICATIONS
•A minimum of 3-5 years’ experience in the life sciences industry operations, legal, regulatory or compliance field.
•Initiative and the ability to work independently.
•Exceptional interpersonal, written and verbal communication skills.
•Process and technical capabilities.
•Strong analytical and problem solving skills.
•business acumen, project and client management skills.
CANDIDATE REGULATORY & COMPLIANCE EXPERTISE
The ideal candidate should have knowledge and experience in the laws, regulations, guidance and industry guidelines impacting a Life Sciences company commercial, marketing, research and clinical operations and activities; including, but not limited to:
oFederal False Claims Act;
oFederal Anti-Kickback Statute;
oFederal Food, Drug and Cosmetic Act; and
oPrescription Drug Marketing Act of 1987.
EDUCATIONAL REQUIREMENTS
•Bachelor of Arts Degree is required.
•Paralegal Certificate, Compliance Certificate, MS in Regulatory Affairs or Regulatory Science is or RAC credential is preferred.
•Masters or Advanced degree is a plus.
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