The incumbent is responsible for assisting the Senior Director, Legal Affairs and COO with the company’s legal compliance activities to ensure adherence with all applicable state and federal laws and regulations. The incumbent will assist in the coordination and support of compliance-related audits and examinations.
The successful candidate will be responsible for a wide variety of the company’s legal matters. This is an individual contributor role which requires a proactive hands-on profile to develop, implement and manage various programs with a growing pharmaceutical company.
- Supporting product commercialization; ensuring timely, accurate, consistent review and approval of all product labeling/marketing materials with a deep understanding of the business’s products and their associated uses; general commercial matters.
- Healthcare and corporate compliance, Off-Label promotion matters, Anti-Kickback/Fraud, False Claims Act issues and Abuse matters; providing training to employees with respect to wide range of issues facing a healthcare products business.
- Corporate contracting – drafting, negotiating and reviewing a wide variety of corporate contracts, including confidentiality, consulting, services, manufacturing, clinical trial, licensing and related agreements.
- Working closely with Business Development, Finance/Accounting, Commercial, and Human Resources functions.
- Assisting with FDA regulatory law and other compliance matters.
- Managing internal team members, constituents, and outside advisors, including active management of outside counsel.
- Other projects as assigned.
Specific Job Knowledge, Skill And Ability:
- Juris Doctor Degree required from an accredited US Law School with exceptional academic credentials and admission to practice law
- At least 4 years’ experience at a top law firm and/or in-house legal departments focusing on pharmaceutical/biotech/FDA law
- At least 4 years of experience with the following:
- In depth knowledge of Regulatory law, including development, clinical trial setup, FDA, medical foods, promotional review, marketing and sales support, product labeling, OTC product laws and regulations
- Compliance, including general corporate compliance, policy and program development, privacy, FCPA, trade compliance
- Experience with the Sunshine Act, the Affordable Care Act and patient assistance programs
- Experience in secondment to a pharmaceutical or biotech company as in-house legal support (optional)
- Experience with life cycle management, NDA approval process
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.