Regulatory Counsel

Legal.io is working with a leading pharmaceutical company seeking a compliance counsel or compliance manager to assist its in-house legal team, on a full-time (40 hours per week) basis for 6 months.

Responsibilities:

• Assists Compliance Counsel Team to research and analyze federal and state legislation, industry guidance, and enforcement activity and assess business risk.

• Reviews marketing and promotional concepts and advises champions and the promotional review committee (PRC) on potential execution risk and mitigation tactics.

• Oversees exclusion and debarment screening of healthcare professional consultants.

• Reviews strategic business plans to identify regulatory risks and confers with Counsel Team to develop solutions and communicate compliance recommendations to stakeholders.

• Supports Field Sales compliance training and other compliance communications.

• Assist with creation and revision of policies and procedures supporting the elements of an effective compliance program.

• Supports industry benchmarking initiatives and analyses.

Requirements:

• Juris Doctor strongly preferred. Bachelors or Masters degree with Certificate in Healthcare Compliance and requisite experience will also be considered

• At least 2 years of substantive experience in life sciences commercial compliance in-house at a pharmaceutical or medical device company and/or at a firm counseling life sciences industry clients.

• In-depth understanding of US fraud and abuse and other healthcare laws and regulations.

• Strong interpersonal, writing, communication, organizational, project management and presentation skills.

• Experience handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.

• Minimum of 3 years with experience with fraud and abuse and other healthcare laws.

• Experience with Veeva Vault platform strongly preferred.

• Experience reviewing healthcare professional (HCP) engagements preferred.

• Able to work well in a team environment and be collaborative and solution-oriented.

Role Details:

Hours: 40 Hours / Week

Type: W2 (through Legal.io)

Benefits: Health, Dental, Vision, 401k

Hybrid: Princeton, NJ (Strong Remote candidates will be considered, but 2-3 days on-site in Princeton preferred)

Duration: 6 Months (From 4/29/2024 until 10/28/2024)