Quality Compliance Analyst
Ashfield Healthcare, LLC

Job Info

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Ashfield Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.

Conduct investigations into potential non-compliance deviations received from various channels including the contact center or client. Document, track and report on non-compliances through to deviation closure.

This is your opportunity to join Ashfield Engage and represent a top biotechnology company!

What's in it for you?

• Competitive compensation
• Excellent Benefits - accrued time off, medical, dental, vision, 401k, disability & life insurance, employee discounts/promotions
• Competitive environment with company wide recognition, contests and coveted awards
• Exceptional company culture
• Recognized as a Top Workplace USA 2021

What will you be doing?

• Actively conduct investigations of potential non-compliance activities in line with program requirements.
• Utilize investigative skills, including ability to probe into root cause(s) during stakeholder interviews
• Advise and support development of corrective and preventative measures based on root cause analyses from non-compliance investigations
• Develop, as needed, investigation support tools and/or internal investigation procedures.
• Track corrective and preventative actions through completion
• Communicate open investigation findings to client project stakeholders
• Trend data and provide summary/annual status report as required
• Trend data and provide summary/annual status report as required
• Determine the need for and request follow-up using appropriate communication methods (fax, email, or phone).
• Work as a team to improve processes and procedures, and perform ad hoc projects for the Quality Assurance Department as assigned.
• Assist with internal and client audits as directed, including corrective action/preventative action work associated with any findings and observations.
• Must safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).

What do you need for this position?

• Current US healthcare professional license: RN, PA, RpH, PharmD or Physician License required
• Bachelor's degree or related work experience preferred
• Minimum 2 years' experience in quality compliance role preferably within REMS or Risk Management department.
• Experience within Regulatory Affairs preferred
• Excellent writing and technical reporting skills required
• Experience leading and conducting Corrective and Preventative Action Investigations and or audits required.
• Proficiency in root cause analysis methodologies preferred
• Familiarity with disease states, medical terminology, and drug interactions or toxicity is required
• Familiarity with reporting Key Performance and Key Quality Indicators (KPIS/KQIs) preferred.
• Proficient in Microsoft Outlook, Word, Excel and PowerPoint
• Exceptional verbal and written communication skills
• Ability to prioritize and organize workflow activities in a fast paced environment
• Strong organizational and analytical skills
• Ability to multi task

• Critical thinking and problem solving skills
• Must have stable, reliable, high speed home internet.
• Must have a designated separate home office space that is quiet and away from distractions

About Ashfield Engage

Ashfield Engage, part of UDG Healthcare plc, is a global leader in commercialization services for the healthcare industry. We partner with our clients across Advisory, Healthcare Communications, Commercial, Patient Solutions and Medical Affairs to build creative, scalable and tailored health solutions that are executed flawlessly, to deliver positive outcomes for patients.

Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.

To learn more about Ashfield Engage, visit us at: https://ashfieldengage.com/

Ashfield Engage is proud to be an equal opportunity employer. Individuals seeking employment at Ashfield are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Ashfield will consider for employment qualified applicants with arrest and conviction records.

Ashfield Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be considered.

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