Compliance Specialist

Olympus Corporation

Center Valley, PA

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Working Location: PENNSYLVANIA, CENTER VALLEY; FLORIDA, MIAMI; MASSACHUSETTS, WESTBOROUGH

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.

Let’s inspire healthier lives, together.

Job Description

The Specialist, Compliance Operations has the primary responsibility for planning, developing, conducting, documenting, and reporting transactional testing activities and field monitoring activities as required by the OCA Compliance Management System, to evaluate effectiveness and identify and report vulnerabilities, using monitoring and transactional testing methods of inquiry, observation, re-performance, inspection, analytics, and confirmation. The incumbent will be responsible for supporting the scheduling, planning, execution, and evaluation of the annual Compliance monitoring and testing plans and will independently test, assess, and evaluate adherence to applicable internal policy and procedure requirements and identify matters requiring action and ensure timely reports and resolutions. The incumbent will also be required to lead or assist with the written standard document management process and on Compliance projects with internal and external stakeholders, to help ensure that the OCA Compliance Management System remains effective and current. Emphasis will be on understanding compliance risks, and analyzing key information obtained from OCA entities, groups and functions, including but not limited to HCP Consulting Management, Sales and Marketing, Professional Education, Medical and Scientific Affairs, and Third-Party Management activities, identifying risks, and reporting results.

Job Duties

* Facilitate and administer the Compliance written standard document management activities. This includes the development, maintenance, review by subject matter representatives, formatting, version controlling, and publishing of OCA Compliance written standards.

* Assist in the continuous improvement, design, execution, and compliance with the OCA Compliance monitoring & transactional testing plans. Conduct and evaluate in-person, virtual, and records review / data monitoring of field employees activities and company records relating to interactions with health care professionals for adherence with Compliance requirements and controls and document results timely. Plan and conduct transactional testing and detailed records reviews of records, business processes, and systems relating to interactions with health care professionals and third-party relationships to test adherence to OCA policy and procedure requirements and controls and document and report results timely.

* Partner with key business stakeholders to understand risk priorities and support the further enhancement of the OCA Compliance monitoring and transactional testing plans.

* Develop an intimate understanding of key business activities, practices, processes, and systems, including but not limited to sales, marketing, service, professional education, HCP consulting arrangements, grants, donations, distributor and other third-party relationships, to facilitate risk-based assessment of business processes and to conduct effective monitoring and testing.

* Perform regular and meaningful analysis and follow up regarding status and results from monitoring and testing activities.

* Develop reports and documentation relative to Compliance monitoring and testing, processes, controls and standards, such as Compliance Department procedures, work instructions, and other control documentation as needed.

* Prepare regular reports and engage in frequent and effective communications, both written and verbal, with the CCO and Compliance Officer Team and business stakeholders, regarding monitoring and testing activities and results, important Compliance issues, corrective actions, date-sensitive information, and important Compliance priorities.

* Demonstrate and maintain a working knowledge of federal, state and international Compliance laws, rules and regulations.

* Other responsibilities as directed by the CCO or Compliance Leadership Team as appropriate and consistent with the role of the position.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree or equivalent combination of education and experience required; a degree in accounting, business or computer science or other scientific field of study an advantage.

* Minimum of two years’ experience monitoring, testing, auditing, regulatory/quality and/or examining corporate business activities.

* Proficiency or fluency in spoken and written Spanish desired.

* Ability to travel domestically or internationally up to 50%.

PREFERRED QUALIFICATIONS:

* Medical device or quality related business activities an advantage.

* Proficient understanding of fraud and abuse, anti-kickback, or other health care compliance laws, rules and regulations applicable to medical device companies strongly preferred.

* Demonstrated strong project management capabilities, including coordination of requests for proposals.

* Strong analytical reasoning, problem solving, research, and critical thinking skills in areas of heightened regulatory risks necessary.

* Proficient experience with data analytic and software and applications such as PowerBI, ACL, Access, Excel, and Word, especially in an SAP environment would be an advantage.

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We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus…True to You. True to Society. True to LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||