Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.
This position will oversee the Compliance Program at a functional level. Most importantly, this individual will serve as the “face” of compliance to the business. This individual will work objectively to resolve compliance issues or concerns within the organization. This individual’s role will be to partner with the business to ensure policies and standards are understood and followed by staff.
Among this individual’s responsibilities will be partnering with the business to ensure compliance processes and standards are clearly understood and followed by staff; working closely with various training organizations to ensure alignment and proper communication and training following system or policy changes; identifying potential areas of compliance vulnerability and risk; providing guidance on handling compliance issues and situations; be the channel of communication to receive and direct as needed compliance related issues; communicate compliance procedures to affected staff in a business practical manner; and monitoring select activities/processes in the business.
Key relationships of this individual will include working with business leadership in Global Medical & Scientific Affairs, Global Research and Development, Corporate Communications, the Compliance Department’s policies training and communications group, Corporate Compliance, regulatory and law departments, and human resources. Key activities of this individual will include managing the day-to-day compliance related questions and issues coming from staff, liaising with various corporate functions as needed, directing compliance issues to appropriate channels for investigation or resolution, providing training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts, remain abreast of external compliance activities, implement corrective action plans as requested, and conduct compliance checks via identified monitoring procedures. Must be able to travel up to 30% of time.
Doctorate degree & 2 years of directly related experience
Master’s degree & 6 years of directly related experience
Bachelor’s degree & 8 years of directly related experience
Associate degree & 10 years of directly related experience
High school diploma & 12 years of directly related experience.
Cross functional experience in biopharmaceutical arenas such as Medical and/or Scientific Affairs, Medical Information / Communications, Medical Sales Liaison, Health Economics, Government Affairs, Payer Policy preferably experience with an emphasis on regulatory or legal requirements in the healthcare industry.
Specific knowledge of the healthcare industry, recent federal and state enforcement activities, and the laws and regulations relating to the development, approval, and commercialization of biotechnology/pharmaceutical products is a plus.
Ability to work independently and in teams.
Ability to prioritize, be proactive, resolve conflicts, meet deadlines, follow through on assignments, and be a team player.
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.