Health Studies Compliance Manager
Santa Clara Valley (Cupertino) , California , United States
Posted: Oct 8, 2021
Weekly Hours: 40
Role Number: 200296882
Imagine what you could do here. At Apple, new ideas have a way of becoming great products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish. Do you love taking on big challenges without precedent? Do you possess a deep knowledge of the legal field and a passion for innovation? As a part of our Legal group, you'll help uphold Apple's high ethical and corporate standards, as well as defend our intellectual property. Working for a company that invents entire categories and industries means you'll be challenged to creatively apply your deep legal expertise to rare and often unexplored aspects of the law. Together with your team, you'll provide the critical support needed worldwide for all Apple products and businesses.
- Extensive knowledge of health and research compliance related laws and regulations, including state, federal, and international research and compliance requirements, including emerging trends and issues
- Experience in building an effective compliance program, including defining, drafting, and implementing health and research compliance policies, procedures, and training.
- Ability to balance different compliance initiatives with a focus on studies, including health and human studies
- Ability to work through ambiguity to find solutions
- Ability to work independently with minimal supervision and collaboratively as a teammate in a fast paced work environment
- Experience with leading organizational change as necessary to establish and implement processes
- Ability to get results in diverse, fast paced environments
- Strong organizational skills, with a keen eye for details
- Excellent oral and written communication skills
- Experience interacting with senior management, both in writing and presenting
- Standout colleague with ability to partner at all levels of the organization
- Certification in Healthcare Compliance (CHC) and/or Research Compliance (CHRC) is strongly preferred.
- Define, develop, implement, and manage a robust overall health compliance program, including, policies, procedures, audits, guidance documents, and training. - Focus on studies and research compliance, including review and oversight of independent review boards, conflicts of interests, policies, processes, procedures, assessments, monitoring and auditing. Also will act as the clinical compliance officer for internal and external studies. - Work closely with health Counsel across the company to ensure compliance with various health laws by employees and third parties. - Analysis of existing and new state, federal, and international legislation to incorporate into compliance programs and training to ensure that Apple remains in compliance as it relates to studies. - Collaboration with study stakeholders across Apple.
Education & Experience
BA/BS, advanced degree preferred.