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US Compliance Counsel - New Hampshire, United States - Epredia
Description
Be a part of a global team where what we do matters At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Continuous Learning – We learn and always aim to be better.
Results – Results matter for all of us.
PHC Group's Compliance Counsel position is an experienced professional in the Legal and Compliance Department of PHC. The position reports directly to the General Counsel of the US. In this role you will provide expert, timely compliance services with some direction and guidance from the General Counsel. The position is expected to represent the company's compliance position in all matters affecting the assigned area or operating company.
Location: This is a remote position and can sit anywhere in the United States.
What you will be doing:
Create and deliver compliance education (Training and Awareness) for employees and managers, in the following areas, Anti-Kickback laws and appropriate HCP interactions, Sunshine Act reporting, FCPA and anti-bribery, insider trading, FDA product promotion, attorney client privilege and attorney communications, and other areas identified by business and legal leadership;
Draft and finalize policies and procedures to align with U.S. legal requirements and support the communication of new policies and procedures to employees and managers;
Provide compliance oversight of HCP engagements, including speaker events and advisory boards;
Provide compliance oversight of Patient Ambassador and Influencer Program;
Develop and implement a compliant framework for Medical Office functions, including medical information requests, off-label questions, Investigator Initiated Research (IIRs), and grant requests;
Provide compliance oversight of US data privacy matters, ensure that website language aligns with federal and state data privacy requirements, and support the Data Security team in maintaining risk mitigation strategies;
Assist the business and members of global legal team in identifying and prioritizing US compliance risks on an ongoing basis and develop and implement monitoring plans and solutions to avoid or manage compliance risks
Execute monitoring according to monitoring plans; Use monitoring findings to identify compliance risk trends; Oversee required remediation or corrective actions;
Support the conducting of internal audits and assist in the implementation of corrective actions required by audit findings.
What you need for success:
Admission to a state bar.
Minimum 5 years of experience as compliance professional or attorney
Minimum 3 years of experience at a healthcare company or institution, or directly involved in the representation of medical device industry clients.
Strong knowledge of medical device industry laws, guidelines, and codes.
Demonstrated leadership skills.
Knowledge and experience in review of promotional materials involving medical devices is preferred.
Knowledge of FDA and FTC regulations is preferred.
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TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
About Us
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.
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