Job Description
Job Description
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions.
Medexus’ current focus is on the therapeutic areas of hematology, oncology, auto-immune diseases, and allergy.
Position Overview
The Associate General Counsel and Compliance Officer works closely with the General Counsel and the Chief Operating Officer to enhance and oversee Medexus’ legal and regulatory compliance program and provide reports to Medexus’ senior management team and board of directors on compliance matters.
The primary responsibility of this role is to oversee, manage, and enhance Medexus’ compliance programs across the United States and Canada.
They chair Medexus’ compliance committees and regularly meet with members of Medexus senior management on the implementation and effectiveness of Medexus’ compliance programs.
They also have an opportunity to actively contribute to corporate, commercial, operational, market-access, and business-development related matters across the organization.
Medexus operates across the United States and Canada, with offices in Toronto (Ontario), Montreal (Quebec), and Chicago (Illinois).
Thus the incumbent in role is a US-trained lawyer who is willing and able, with appropriate guidance and advice from outside counsel, to support the organization’s needs across both markets.
Key areas of focus include compliance with key healthcare laws (eg anti-kickback laws, Medicaid best price laws and Medicare Part D regulations, FDA and Health Canada laws and regulations, and pharmaceutical disclosure and compliance laws), other key laws (eg False Claims Act, privacy and information security laws, consumer protection laws, antitrust / competition laws, and anticorruption / antibribery laws), and industry codes, guidance, and agreements to which Medexus adheres (eg guidance on interactions with healthcare professionals, guidance on direct-to-consumer advertising and interactions with consumers, and OIG compliance program guidance).
Position Responsibilities
- Oversee and manage an effective legal and regulatory compliance program, including evaluating and enhancing existing policies and operating procedures, implementing any enhancements or new initiatives across the organization, and monitoring and auditing adherence on an ongoing basis.
- Identify areas of actual or potential compliance risk and opportunities for mitigation initiatives, including internal investigations and corrective action plans as necessary.
- Partner with the General Counsel, Chief Operations Officer, and other members of Medexus senior leadership to further develop and maintain a strong culture of ethics and compliance across the organization through employee training and other culture-building initiatives.
- Work with managed markets to negotiate pricing agreements and manage compliance with government price reporting requirements.
- Draft and negotiate commercial, operational, and other business agreements.
- Provide support on other matters as requested by the General Counsel, the Chief Operating Officer, or other departments and functions, including Regulatory Affairs, Medical Affairs, Quality, and Commercial Operations.
Education, Experience & Skill Requirements
- JD from an accredited law school.
- Admitted to practice law in one or more US states.
- 7-10 years of combined law firm and in-house experience.
- Demonstrated subject matter expertise in pharmaceutical sector compliance, preferably with one or more high-growth pharmaceutical or other life sciences companies including experience supporting commercial operations.
Additional Information
Travel : up to 20%
Salary Range : $200,000 - $250,000
Location : Remote
Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law.
We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Our employees, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us at [email protected] to request accommodation.