Sr Compliance Specialist

AIM OF THE POSITION

The Senior Compliance Specialist will serve as a subject matter expert and assist with the development and implementation of a best practices surrounding ethical interactions with healthcare providers appropriate billing practices and ongoing maintenance and maturation of an effective global compliance program. The Senior Compliance Analyst will collaborate with business stakeholders in identifying and understanding compliance requirements assessing risks and recommending processes and controls to meet those requirements.

POSITION WITHIN THE ORGANIZATION

1. Reports to Sr. Compliance Manager

2. Cooperates with all departments

3. Participates in:

Crossfunctional projects and meetings

Risk assessments and audits

Education of the workforce on relevant laws and requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES

Participates in the regular review of compliance risks and development of work and audit plans.

Assist in the development and maintenance of effective policies and procedures to ensure adherence to relevant healthcare laws and regulations.

Develop implement and maintain training and awareness communications to support policies and procedures including monitoring employee completion of assigned training tasks.

Investigate reported compliance concerns and coordinate corrective and preventative actions with business leaders and employees to ensure ongoing compliance.

Plan develop and execute monitoring and audit protocols to measure organizational compliance with policies and procedures and work with business management to implement corrective actions.

Conduct sanction and debarment screening of healthcare providers vendors and board members.

Assist with thirdparty due diligence process for global distributors including screening contract management and risk mitigation.

Assist with global physician payment transparency requirements (i.e. US Open Payments Belgium Transparency Platform French Sunshine Act etc..

Respond to employee questions and inquiries surrounding area of responsibility.

Compile compliance metrics and data to develop reports and slides to be used in executive compliance committee meetings.

Develop strong relationships throughout areas of responsibility to foster a collaborative balanced and proactive approach to implementing compliance programs.

Maintain current and accurate knowledge of existing and emerging trends industry best practices and laws and regulations in assigned areas of responsibility.

Assist in the training and mentoring of other members of the compliance team.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

KEY CONTACTS

Internal:

External:

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

Undergraduate degree required (preferably in clinical laboratory or life sciences field) graduate degree preferred

EXPERIENCE

5 years of compliance experience within a global healthcare corporation (laboratory meddevice or pharma) required.

Certification in healthcare compliance (CHC CCEP etc. or equivalent.

In depth experience with crossfunctional teams and demonstrated ability to partner effectively with individuals at all levels of the organization to address complex compliance and operational issues.

KNOWLEDGE SKILLS AND ABILITIES (KSAS)

Specific Knowledge Required:

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

Demonstrated working knowledge of the elements of effective compliance programs enforcement agencies and enforcement initiatives.

Demonstrated experience implementing compliance program elements to support adherence to US and global healthcare laws regulations and requirements including Stark Law US AntiKickback Statute Medicare and Medicaid requirements global antibribery laws global transparency reporting and industry association guidance on ethical interactions with healthcare providers.

Ability to analyze and accurately interpret complex regulatory requirements.

Proven ability to use critical thinking skills to analyze new and complex business projects against regulatory requirements and provide balanced workable solutions to the business.

Demonstrates ability to proactively manage and support change in a dynamic environment.

Highly skilled in taking complex concepts and simplifying them for targeted audiences.

Ability to autonomously develop work plans and meet project timelines and milestones.

Strong and effective written and oral communication and presentation skills.

Ability to come into the office in Irvine 3xs weekly.

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

o Demonstrates professional collaborative and positive demeanor

o Strong ability to manage and deescalate conflict

o Active listener who seeks understanding and displays empathy for opposing viewpoints

PRIVACY NOTICE: To review the California privacy notice click here: https://agendia/privacypolicy/

Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office)

General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Maintains a clean neat and orderly work area.

Adheres to Department Specific Safety Guidelines.

Standing sitting walking bending reaching manual manipulation and lifting up to 15 pounds.

TRAVEL

o Ability to drive/fly routinely internationally and domestically for up to 15

OTHER DUTIES

Other duties as required by management