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Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Director, Compliance Counsel Job in California > Director, Compliance Counsel

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Director, Compliance Counsel

Refer job# GNKG144643

Director, Compliance Counsel The candidate will work collaboratively with Legal team partners on all topics relating to healthcare compliance. Assist the Head of Global Compliance with the implementation and interpretation of healthcare compliance policies. Periodically review/update written policies and procedures, including the company s Code of Conduct. Provide counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities. Advise on aspects of the Food, Drug and Cosmetic Act (FDCA), Federal and State Anti-Kickback Statutes, False Claims Act, HHS OIG fraud and abuse regulations and opinions, and HIPAA laws and regulations. Partner with functional teams to establish a rapport and positive working relationship with respect to compliance initiatives at Atara. Work collaboratively and creatively with stakeholders to provide compliance support and day-to-day counseling. Clearly and effectively render practical, timely advice while serving as a member of various cross-functional teams to support the successful product launch and associated activities. Provide legal advice, education, training and direction on activities that implicate FDA promotional laws and regulations, Sunshine Act/Transparency laws, scientific publications and data disclosure and related laws, regulations and industry standards (e.g., PhRMA Code, ICJME and GPP standards, ACCME guidelines). Review and provide guidance on disease education/disease awareness campaigns and promotional marketing materials, speaker programs, grants and sponsorships, Investigator Sponsored Studies, market planning activities, sales incentives and direction, commercial learning, medical communications, Medical Science Liaisons, patient education materials, reprint distribution, and publication plans. Provide guidance to Commercial and Medical Affairs functions (including senior managers) on the appropriate interactions of Sales, Market Access, and Medical Affairs field-based employees. Maintain an effective compliance communication program for the organization, including promoting the use of the compliance hotline; (b) heightened awareness of Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures. Respond to alleged violations of rules, regulations, policies, procedures and Code of Conduct by recommending the initiation of investigative procedure; collaborate with other departments to direct compliance issues to appropriate channels for investigation and resolution. Assist with the roll out of effective training programs. Should have JD degree plus at least 6+ years of relevant experience. Must have 2+ years of Biopharma experience. Experience in the development, initiation, maintenance and revision of policies and procedures for the general operation of a compliance program and its related activities to prevent illegal, unethical or improper conduct is required. Experience in and knowledge of industry standards and regulations for and risks facing a global pharmaceutical or biotech company, including anti-bribery, anti-corruption, 3rd party distributors, anti-kickback, off-label promotion, etc is required. Must have in-depth knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance and testing activities. Experience with data privacy regulations (HIPAA, GDPR) preferred. Multi-geographic experience preferred. Experience in developing and maintaining effective lines of communication, including the management of a compliance hotline is required.

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