Compliance Manager, Pharmaceutical

Compliance Manager (JN
- San Jose, California

Salary: USD
51 - USD
59 per hour

• Develop and maintain the claims management process for addressing any potential or actual health or health-related claims including medical malpractice claims, which may be eligible for FTCA coverage.
• Oversee the claims management process and processing of claims-related activities under FTCA and serve as the claims point of contact.
• Analyze internal business systems to ensure compliance with industry regulations and ethical standards.
• Create, modify, update and implement policies.
• Design control systems to address cases of violation of internal business policies.
• Design ongoing training programs for employees of the organization.
• Liaise with Sr. Leadership and management team to ensure that all business operations are in line with the organizational policies.
• Advise Sr. Leadership on business operations relating to investment, risks and any other policy development.
• Participates in the review and recommendation of department policies and procedures to ensure operations are compliant with applicable laws and regulations. When requested, assists staff with job aids and forms.
• Monitoring and Testing
  - Leads compliance reviews and documents and supports compliance findings. Drafts compliance reports and communicates findings to management.
• Conducts initial reviews of alleged compliance violations and escalates to management as needed.
• Monitors and tracks applicable federal and state laws and regulatory guidelines and regulations applicable to the organization.
• Identifies impacted business units and coordinates with business teams to implement necessary operational or policy changes in response to regulatory change.
• Supports product development and process change management by participating in meetings with project teams to ensure compliance with regulations and internal policies and procedures, as applicable.
• Independently tracks and records changes to federal regulation and works with organization to determine impact to processes and operations.
• Independently researches laws and regulations impacting the organization.
• Regularly responds to staff regarding questions on compliance issues with appropriate, risk-based, and properly supported guidance.
• Identifies training needs of organization and recommends training subjects to Compliance and/or Learning & Development.
• Reviews marketing forms, advertisements, disclosures, website and other materials for compliance.
• Aids the Director of Compliance in reviewing and analyzing regulatory proposals issued for comment by various regulatory agencies.
• Experience with regulatory examiners (responding to regulatory requests, producing documents and/or leading exams).

• Performs other duties that may be required and assigned by the supervisor.
• Must have strong PC skills. Excellent oral and written communication skills.
• Must effectively communicate regulatory rules and requirements to supported business units. Communicates accurate and timely information to key stakeholders, and models professionalism, openness and respect.
• Must have good problem-solving skills and the ability to work independently.
• Handles moderately complex issues and problems and refers more complex issues to higher-level staff.
• Demonstrates in-depth knowledge and expertise of applicable lending laws and regulations, including knowledge of key industry resources, to ensure sound guidance is provided.
• Develops and builds functional expertise in processes.
• Self-starter, organized, analytical, detail oriented.
• Attends workshops, training, and meetings as needed, and as requested.

• Four-year college degree or equivalent.
• Significant experience in researching and interpreting laws and regulations
• Compliance certification from a recognized trade organization (e.g., CUCE, NCCO, CRCM) preferred, but not required.

This position requires:

• Sitting, walking, and standing associated with a normal medical, clinical and administrative office environment, with some bending, reaching, stretching, and lifting up to 25 pounds.
• Manual dexterity for tasks involving standard office equipment and computer keyboard, including repetitive movements, such as typing.
• Traveling to work sites, including some exposure to outside elements.
• Exposure to potentially dangerous materials and situations, requiring adherence to extensive safety precautions and possibly the use of protective equipment.