Analyst - Regulatory Compliance

We are eClinicalWorks. We are a privately held leader in healthcare IT, providing comprehensive, cloud based EHR/PRM solutions to medical professionals worldwide to improve workflows and reduce the risk of physician burnout. We care. We are committed to positive change. And that's where you come in. Do you value creativity and innovation? Great, so do we. At eClinicalWorks, we share a passion for improving healthcare through dedication, education, and teamwork. Everyone has that one thing they're really good at. We value your talent and want you to join our fast-paced, fun, and culturally diverse environment. Ready to make a difference? Apply today.

Position Overview:

The Pharmacy Regulatory Compliance - Analyst will play an integral part in important decision making, contributing to maintaining the Software Development Life Cycle of the Pharmacy application and ancillary products, helping improve eCW's compliance processes, and working to ensure the processes are effectively and promptly carried out.

Job Functions/Responsibilities

• Monitor and track state and federal regulatory activity impacting eClinicalWorks' Pharmacy software certification or compliance with state specific requirements.
• Engage and build relationships with regulatory bodies and attend public meetings.
• Obtain broad familiarity with the Pharmacy/Health IT Certification Program and the Information Blocking regulation.
• Assist with DEA EPCS, federal and pharmacy state board specific compliance activities.
• Create and maintain team policies and procedures.
• Create and present internal and external educational materials.
• Aid the Team Lead in the timely analysis of potential regulatory issues.
• Responsible for coordinating and ensuring the complete compliance to federal and state specific regulations at all times which includes but is not limited to Implementation of Corrective Action Plan and Implementation and coordination of Preventive Action Plans.
• Plan and prepare to demonstrate regulatory during surveillance activities.
• Have a proficient understanding of policies and regulations related to Pharmacy Regulations both federal and state specific.
• Prepare education materials related to Pharmacy Regulations/requirements and make them available to all eCW employees as an ongoing reactive and proactive maintenance activity of our pharmacy product.
• Analysis of the P1 support cases, JIRAs, and IRs requesting Pharmacy Regulatory Compliance review.
• Analyze potential Pharmacy state/federal regulations and compliance issues identified through support cases, Jira, patient safety issues and internal requests.
• For incidents within the scope of Pharmacy regulations, create customer notifications to notify the customers.
• Create Training Plan and Education materials for company-wide education on regulatory criteria.
• Manage the process for creation of all corrective action plans relating to identified regulatory/certification issues on production releases.
• Work with Development, Quality Assurance and Deployment teams to ensure that the identified regulatory/certification issues are resolved.
• Work with product management, engineering, quality assurance and release management teams to ensure that regulatory/certification issues are resolved in timely manner.
• Work with cross-functional teams to complete documentation for root cause analysis and corrective and preventive action plans related to such issues.
• Work with cross-functional teams to improve and incorporate tools that help eCW with ongoing reactive and proactive maintenance activities of our pharmacy product.
• Work on adhoc reports and team projects related to regulations(federal/state).
• Perform other job duties as assigned

Experience/Education Requirements:

• PharmD Degree required; Law Degree preferred
• Advanced degree/certification in pharmacy, law, policy, compliance or a similar field, or equivalent professional experience
• Adheres to all company policies and mandatory compliance protocols as required by eCW
• 5 or more years of experience working as a pharmacist
• Proven experience with reviewing state and federal regulations governing pharmacies, pharmacists, and the distribution of medications, as well as experience with relevant legal issues like licensing, compliance and litigation
• Experience and understanding of requirements for the clinical workflow in an in-house/retail pharmacy setting
• Knowledgeable with DEA EPCS, federal and pharmacy state board specific program

Other Skills/Abilities

• Familiarity with federal/state specific programs
• Domain knowledge on functionalities in Pharmacy that fall under regulatory requirements
• Experience in the creation or revision of educational, policy, regulatory or legal materials
• Teamwork
• Advanced written and oral English and interpersonal communication skills, with ability to clearly and concisely articulate facts and ideas
• Problem solving skills
• Analytical and adept critical thinking skills
• Experience presenting educational or policy materials to small and large groups
• Comfortable with highly technical subject matter
• Responsible self-starter with excellent time-management and organizational abilities

eClinicalWorks offers a rich suite of benefits which include the following: eighteen days of Paid Time Off per year which scales based on tenure; nine Paid Holidays and one Floating Holiday; insurance for eligible employees which includes medical, dental, vision, basic life, short term disability, long term disability, business travel accident, and accidental death and dismemberment.

As well, we offer a 401(k) plan with a Company safe harbor contribution; Flexible Spending Account for Health Care and Dependent Care for eligible employees; limited personal leave; additional voluntary benefits, including additional insurance (hospital indemnity, critical illness, accident, supplemental life, short term disability buy up, pet), genetic testing, legal plan, and supplemental accidental death and dismemberment; and an annual discretionary bonus for eligible employees.

eClinicalWorks is an Equal Opportunity Employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences that bring us together and help create a healthy world.