Global Healthcare Compliance Officer

Overview

Reporting to the Chief Compliance Officer, the Global Health Care Compliance Officer (HCO) will assist with compliance matters including healthcare compliance and regulatory matters and the including global reporting requirements with a wide variety of internal and external global partners, including commercial, clinical, and government functions/organizations, as well as provide other general compliance support to the company.

Essential Functions and Responsibilities 

• Provide sound and practical advice on healthcare compliance and regulatory matters in oncology, including support for compliance issues related to sales, marketing, and medical affairs activities, government programs, federal healthcare program reporting, medical education programs, and advertising and promotion of biologic products, including legal support for training, internal policy development, medical review committee, and promotional review committee functions.
• Advise key business partners on complex commercial contract issues and assist with support for clinical and other business contract issues, negotiations, rights, and obligations.
• Continuously identify compliance risks and vulnerabilities. Develop and implement corrective action plans to address problematic areas and mitigate future risks. Assist the Chief Compliance Officer in the design and execution of ongoing Compliance Risk Assessment and management of Compliance Committees.
• Oversee the development, revision, and communication of key compliance policies, procedures, and training to meet the company’s evolving risk profile, including topics such as medical necessity, billing, coding, anti-kickback statutes, and federal false claims.
• Conduct or collaborate in internal investigations of reported misconduct driving a fair, consistent, fact-based and timely resolution. Collaborate with Legal, HR, Global Security, and other key departments in investigating and remediating ethical issues. Ensure accurate documentation of reports, investigations, and outcomes for both internal and external audit requirements.
• Oversee monitoring processes and remediation efforts for compliance risks and violations, including engaging external auditors, consultants, or legal counsel when necessary.
• Act as lead for implementation and upkeep of systems that are fully or partially owned by Compliance, such as transparency reporting data warehouse / platforms, HCP engagement to ensure accurate and timely reporting for all global requirements.
• Assist with legal department objectives and coordinate with outside counsel.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel 

• Occasional travel (up to approximately 10% of time) may be required.  

Required Education, Skills, and Knowledge 

• At least 15 to 20 years of experience in pharmaceutical or biotechnology commercial compliance management and oversight and/or related work in a government or institutional setting.
• Must have experience with regulations and regulatory guidance specific to advertising and promotion of biologic products, knowledge of laws, regulations, industry guidance and best practices regarding compliant sales, marketing, medical affairs activities, and pharmaceutical manufacturer activities.
• Requires strong written and oral communication and interpersonal skills as well as excellent judgment in the handling of compliance matters.
• Must possess creative problem-solving, strong negotiation and risk assessment skills, and a dedication to quality and the highest professional standards.
• Proficiency in Microsoft Office products is required.
• Excellent team skills as well as the ability to work independently is required 

Preferred Education, Skills, and Knowledge 

• Additional experience in privacy, in a pharmaceutical or biotechnology environment is preferred.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. 
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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