Associate Director/Director Compliance

Boulder, CO | Legal

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Job Description

Job Summary

The Compliance Associate Director/Director manages critical compliance activities that are integral to the development, implementation and execution of the US Compliance Plan to ensure corporate compliance with US regulatory requirements. This position reports to the Vice President and Head of Compliance and will work closely with all areas the company, but with specific focus on the US Commercial, Medical Affairs, and Clinical organizations, to design, implement, and oversee the enforcement of compliance policies and programs.

Job Responsibilities

• Managing the commercial compliance documents, including the design, development and implementation of new SOPs.
• Responsible for compliance training, and related compliance projects
• Identifying specific company compliance risk areas to incorporate into the company compliance plan
• Assisting in the development and implementation of compliance-related controls, including FAQs, process flows, and automated systems
• Overseeing the development and implementation of live and web-based compliance training to managers, employees, and consultants
• Assist with management of the Compliance Plan and communicating progress on program development to functional leads and various levels of management, verbally and in written materials
• Developing, managing and performing company compliance monitoring, audit programs and related correction action plans
• Conducting and managing compliance investigations regarding allegations of compliance and/or ethical policy deviations as well as the resulting corrective action plans
• Communicates with and counsels managers and other employees on company compliance issues

Skills & Requirements

 Qualifications
• Demonstrated knowledge of key biotech/pharmaceutical compliance laws, regulations and industry standards applicable to interactions with healthcare professionals (HCPs) by pharmaceutical manufacturers (e.g., anti-kickback laws, healthcare fraud and abuse, off-label promotion, Privacy, PhRMA Code, State Marketing laws, and Transparency laws)
• Strong program management, operations, process-orientation, data analytics, and technical expertise to effectively design, develop and implement healthcare compliance processes, controls, and workflows
• Demonstrated track record of partnering with business management to provide guidance and implementation of effective compliance processes
• Demonstrated track record of building compliance partnerships in the capacity as a commercial compliance professional
• Capable of working in a fast-paced environment, to address risks collaboratively and with solutions that are company-appropriate
• Exceptional critical thinking and problem solving skills
• Able to prioritize key risk areas in verbal and written communications
• Capable of managing and prioritizing multiple tasks and objectives
• Strong verbal and written business communication skills

Education and Experience
• Bachelor’s degree is required and 5-10 years of work experience in healthcare compliance in the pharmaceutical/biotech and/or medical device industry, with a consulting firm, or with a healthcare organization such as a payer, provider, or similar entity is required.


Working Conditions

Up to 30 percent travel is required.