Director, Senior Counsel – Regulatory & Compliance
Foundation Finance Company LLC
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Salary
💰 $230,000 - $285,000 per year
Job Level
About the role
- responsible for a broad range of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry
- provide expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs and Corporate Compliance
- assist with, and at times manage, areas of legal responsibility that become relevant through the commercial lifecycle of the Company's various products
- provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
- serve as a Legal representative on the Company's promotional review committee, including review of promotional and sales training materials
- provide legal support for the Company’s Patient Relations function
- assist with reviewing, drafting and/or revising compliance related policies and standard operating procedures
- assist with privileged compliance audits and investigations
- provide guidance to the Company’s Compliance Committee
- manage outside counsel on compliance and regulatory matters
- perform all other related duties as assigned
Requirements
- Juris Doctorate (JD) from an accredited law school
- 10+ years of experience as an attorney
- 8+ years of experience in healthcare and FDA law
- 4+ years of experience as in-house counsel at a pharmaceutical or biotech company
- Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products
- Effective communicator and collaborative team member
- Strong written communication and drafting skills
- Mac/PC and MS Office proficient
- Ability to work in a fast-paced, dynamic environment
Benefits
- medical / dental / vision / prescription coverage
- employee wellness resources
- savings plans (401k and ESPP)
- paid time off & paid parental leave benefits
- disability benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Juris Doctoratehealthcare lawFDA lawcompliance auditslegal draftingregulatory compliancelegal researchcollateral legal managementpolicy developmentlegal support
Soft Skills
effective communicationcollaborationteamworkstrong written communicationadaptabilityproblem-solvingattention to detailorganizational skillsleadershipinterpersonal skills