Remote - Compliance Counsel

United States, IL, United States of America (Remote)

Job location: 100% Remote

Travel: Domestic travel, very limited.

Compensation: $160,000 to $180,000 + bonus (12%)

Benefits: Medical, Dental, Vision, PTO/Holidays + 401k + 100% match up to 6%

Education / Certifications:  Must have a Juris Doctorate/JD

Required Experience:  

  • 5 or more years of experience as a compliance professional or attorney, 
  • Strong knowledge of medical devices, pharmaceutical industry laws, guidelines, and codes.

Preferred Experience:

  • Knowledge and experience in reviewing promotional materials involving medical devices is preferred.
  • Knowledge of FDA and FTC regulations is preferred, but not required.

Job Description Summary

Compliance Counsel position is a competent, experienced position in the Legal and Compliance Department. The position reports directly to the General Counsel and Chief Compliance Officer, Americas. The position is relied on to provide expert, timely compliance advice with some direction and guidance from the GC. The position is expected to represent the company's compliance position in all matters affecting the assigned area.


Job Description

MAJOR TASKS AND RESPONSIBILITIES OF POSITION:

  • 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 Programs.
  • 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.


QUALIFICATIONS:

  • Admission to a state bar.
  • 5 years of experience as compliance professional or attorney, with at least three to four years 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, with the ability to prioritize, plan, and organize heavy workloads, while exercising discretion and independent judgment.
  • Ability to work independently and as a member/leader of local and global teams in a matrix organization.
  • Ability to: understand, explain, and apply policies, processes, and procedures; evaluate complex situations; and resolve issues with minimum supervision.
  • Excellent analytical skills and communication skills (both verbal and written), with a high level of attention to detail.
  • Adept at answering questions and providing guidance to internal stakeholders from different countries; and
  • Time management skills are essential.


Remote - Compliance Counsel

Job description

Remote - Compliance Counsel

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