Regulatory Counsel
4 weeks ago
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 consideredAt 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 / WeekType: W2 (through Legal.io)Benefits: Health, Dental, Vision, 401kHybrid: 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)by Jobble
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