Compliance Manager-US

Summary:

The Compliance Manager is responsible for developing, revising, implementing, and promoting awareness of LMI’s business ethics policies, monitoring the organization’s standards of conduct and ethical relationships with customers, contractors, suppliers, employees, and the communities in which business is conducted. Administer and maintain an effective compliance program for a growing pharmaceutical company, being commercially active in the US, EU and UK. 

The responsibilities below do not represent the entirety of the role but rather an overview of some key responsibilities and requirements.

Key Responsibilities & Requirements:

• Maintain an effective compliance communication program for the organization, including promoting: (a) use of the compliance hotline; (b) heightened awareness of Code of Conduct and applicable compliance policies and procedures, and (c) understanding of new and existing compliance issues and related policies and procedures.
• Oversee and actively manage development and regular revision of compliance policies and procedures designed to prevent illegal, unethical, or improper conduct and evaluate the need for additional policies and procedures.
• Conduct Risk Assessment and Mitigation Planning (RAMP) with applicable business groups.
• Perform third party due diligence per LMI policy and create third party due diligence reports for stakeholders.
• Identify potential areas of compliance risk and implement corrective action plans for resolution of problematic issues.
• Chair the LMI Compliance Committee and be an active leader for Compliance.
• Develop and implement compliance audit/monitoring plan for the year and ongoing to remain abreast of compliance activities.
• Bachelor’s degree required; advanced degree preferred (i.e., Law Degree); license to practice law highly preferred.
• Minimum 5 years of experience working as in-house compliance in related medical devices, biotechnology or pharmaceutical industry.
• Three years of experience leading and working with departments on compliance Risk Assessment and Mitigation Plans (RAMPs).
• Demonstrated compliance policy and standard operating procedure drafting experience.
• Internal investigations experience.
• In depth understanding of risks facing a global pharmaceutical company including Anti-Bribery, Anti-Corruption, 3rd party distributors, Open Payments, Anti-Kickback, etc.

Physical Requirements: 

• Able to remain in a stationary position for extended periods of time.   

• Able to consistently operate a computer, keyboard, and other office productivity machines.   

• Able to observe details at close range (within a few feet of observer).   

• Able to lift, push, pull or move items to 25 pounds unassisted.   

• Appropriate work attire (business casual) required to represent self and company professionally during planned and unplanned virtual calls or in-person events.   

• The ability to concisely communicate and exchange accurate information and ideas so others will understand.     

Work Environment:  

• Fully remote home based. The home office must comply with company security & safety requirements including but not limited to set up and document storage.   

• Able to work variable or extended hours to meet the needs of a global organization including potential weekends, travel, and accommodating varying time zones.   

Travel Requirements:  

• Availability and ability to attend congresses and events.  

• Domestically:  up to 25%  / Internationally:   up to 5%  

• Valid driver's license and ability to safely operate a properly insured motor vehicle