Supports the planning and executes compliance and privacy auditing and monitoring activities.
Supports the daily Data Loss Prevention reviews and communications.
Manages the day-to-day operations of the annual compliance auditing and monitoring plan.
Initiates and coordinates corrective and preventive action for areas of noncompliance as identified in the periodic audits and/or through the reporting system.
Supports the implementation of annual compliance risk assessments.
Conducts monitoring of AI activities/plans, including but not limited to, support for timely and fulsome assessments of AI pilot/use case requests and supports the AI Steering Committee
Manages the annual Due Diligence review for agents and distributors
Supports the Business Compliance & Integrity Department with generating reports used to track and trend activities related to compliance.
Periodically reviews and recommends updates to compliance policies, procedures and annual compliance auditing and monitoring plan to ensure relevance in providing guidance to management and employees.
Identifies potential areas of compliance vulnerability and risk, facilitating corrective action plans for resolution.
Remains abreast of relevant regulatory publications and settlements.
Collaborates with Chief Compliance & Privacy Officer to develop effective compliance training programs to include new employee orientation, targeted education and ongoing education for management and employees.
Additional Responsibilities
Monitors the compliance mailbox, answers questions, and troubleshoots problems for users by phone and email.
Provides reports as directed and/or requested to the Chief Compliance & Privacy Officer on issues and concerns.
Collaborates with Chief Compliance & Privacy Officer to develop periodic reports for senior management and the board.
Assists with the promotion of a compliance culture for the organization.
Undertake special projects and duties as identified or assigned.
Bachelor's Degree required
Work Experience
8-10 years of work experience with 4-7 years of healthcare industry related experience in compliance, operations, privacy, quality, training or applicable experience in pharmaceuticals or medical devices.
Project Management certification preferred (or experience in lieu of)
Familiarity with compliance, healthcare and privacy laws and regulations, including but not limited to: FCPA, Anti-Kickback, GDPR, PIPL, EU AI Act and other AI regulations
Knowledge, Skills and Abilities
Exceptional attention to detail, analytical, and statistical skills.
Strong written and verbal communication skills.
Strong organizational and project management skills.
Strong technology skills including Excel and PowerPoint; and experience creating data analytics preferred.
Ability to work with and maintain confidentiality of company and personnel data.
Must be a self-motivated team player with proven ability to identify issues and manage priorities in a fast-paced environment with a bias for action and a strong sense of ownership.
Must be able to meet deadlines and manage multiple priorities.
Responsible for identifying system, data, or process improvements that increase efficiency, compliance, or reduce cost to the business.
Makes recommendations to compliance leadership, develops and supports execution of plans to implement recommendations in conjunction with compliance management.
Demonstrates an aptitude for critical thinking in complex situations and an ability to synthesize ambiguous data into concrete insights and other duties as assigned.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
Able to comply with the company’s safety and quality policy at all times.
Preferred experience as a compliance professional responsible for the development and implementation of risk assessments and monitoring and/or audit programs with working knowledge of DOJ’s & OIG’s guidance of an effective compliance program.
Review and interpret healthcare compliance regulations, policies, procedures and corrective action plans.
Ability to be flexible, manage a diverse and demanding workload with minimal supervision.
Ability to work effectively within a team environment.
Clear, concise and persuasive writing and presentation skills.
Decisive and capable of exercising good judgment under pressure.
Demonstrated ability to problem solve and manage unforeseen changes to plans.
Excellent interpersonal skills and ability to work as a team player.
Additional Requirements
Weekly staggered work schedule to support APAC and Europe
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.