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Clovis Oncology, Inc. Senior Manager, U.S. Healthcare Compliance in Boulder, Colorado

Job Summary

The Senior Manager, U.S. Healthcare Compliance will work with the Clovis legal and compliance team to provide guidance and support across the lifecycle of Clovis’ products, including pipeline, commercial and medical affairs functions, with a specific focus on designing, implementing, and overseeing the training and enforcement of healthcare compliance policies and programs.

Job Responsibilities

• Operationalizing compliance policies by leading in the design, development, and implementation of SOPs and program controls; • Developing and providing training to internal clients, partners, and stakeholders on key compliance policies and procedures; • Conducting Monitoring and Auditing of Clovis transactions and interactions with the healthcare community; • Identifying specific compliance risk areas to incorporate into the company compliance plan; • Serving as a standing or ad hoc member of business or leadership teams and providing compliance input and expertise into business decisions, including the development of solutions-oriented risk mitigation strategies; • Reviewing business materials (including brand plans, promotions, medical plans, training documents) requiring compliance operational input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics; • Conducting and managing compliance investigations regarding allegations of compliance and/or ethical policy deviations as well as the resulting corrective action plans.

Qualifications

• Demonstrated knowledge of key biotech/pharmaceutical compliance laws, regulations and industry standards applicable to interactions with healthcare professionals by pharmaceutical manufacturers (e.g., anti-kickback, healthcare fraud and abuse, off-label promotion, transparency, PhRMA Code); • Strong program-management, operational, analytical, 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; • Capable of working in a fast-paced environment while addressing risks collaboratively and with solutions that are company-appropriate; • Exceptional critical thinking and problem-solving skills; • Capable of managing and prioritizing multiple tasks and objectives; • Strong verbal and written business communication skills.

Education and Experience

• Minimum of 8+ years of experience in the biotech/pharmaceutical or medical device industry, with at least 3-6 years of relevant work experience in the healthcare compliance field; pharmaceutical/biotech and/or medical device industry; • Bachelor’s degree is required; • Science or accounting background a plus.

Working Conditions

• Office-based, up to approximately 30% travel.

Qualifications

• Demonstrated knowledge of key biotech/pharmaceutical compliance laws, regulations and industry standards applicable to interactions with healthcare professionals by pharmaceutical manufacturers (e.g., anti-kickback, healthcare fraud and abuse, off-label promotion, transparency, PhRMA Code); • Strong program-management, operational, analytical, 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; • Capable of working in a fast-paced environment while addressing risks collaboratively and with solutions that are company-appropriate; • Exceptional critical thinking and problem-solving skills; • Capable of managing and prioritizing multiple tasks and objectives; • Strong verbal and written business communication skills.

Education and Experience

• Minimum of 8+ years of experience in the biotech/pharmaceutical or medical device industry, with at least 3-6 years of relevant work experience in the healthcare compliance field; pharmaceutical/biotech and/or medical device industry; • Bachelor’s degree is required; • Science or accounting background a plus.

Working Conditions

• Office-based, up to approximately 30% travel.

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