Promote innovative treatments for Acute Gouty Arthritis through strategic engagement with healthcare providers, while driving market growth and ensuring seamless patient onboarding in collaboration with cross-functional teams.

Role Description Quality Specialist- Medicare D Quality role administers the quality management system to manage the review of clinical processes, documentation, and patient records. Interprets regulatory requirements from agencies and governing bodies to assist in the development of compliance policies and procedures. - Rework team hours of operation are Monday through Friday from 6:00 AM - 7:30 PM Central Standard Time (CST) - Schedule flexibility including nights, weekend, and holiday coverage. - This is a full time work from home position. Additional Responsibilities include but are not limited to the following: - Learning the rework queues for each line of business - Working rework reports timely - Researching and troubleshooting failed claims - Adding and/or editing overrides in RxClaim - Logging audits and errors accurately and timely - Ability to identify trends and provide suggestions for process improvement - Researching and correcting any issues found in the overall process - Raising issues to Coverage Determination Clinical Pharmacists and Management team as needed - Reading, analyzing, and interpreting general business correspondence, technical procedures, and governmental regulations - Solving practical problems and dealing with multiple concrete variables in standardized situations - Performing basic mathematical calculations - Ensuring all cases are properly closed - Ability to interpret a variety of work instructions provided through multiple mediums - Ability to anticipate needs and resolve issues with urgency and to meet quality and production standards Qualifications - 2 years of Coverage Determination & Appeals experience - MHK, RxClaim, and People Safe proficient - Meeting quality and productivity metrics in current role Requirements - 3 years of Coverage Determination & Appeals experience (Preferred) - 1 year of Medicare PART B experience (Preferred) - MHK, RxClaim, and People Safe proficient (Preferred) - Meeting quality and productivity metrics in current role (Preferred) Education - High School Diploma or equivalent GED Benefits - Comprehensive benefits package designed to support the physical, emotional, and financial well-being of colleagues and their families - Medical, dental, and vision coverage - Paid time off - Retirement savings options - Wellness programs and other resources, based on eligibility Pay Range The typical pay range for this role is: $18.50 - $42.35. This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography, and other relevant factors. This position is eligible for a CVS Health bonus, commission, or short-term incentive program in addition to the base pay range listed above.

Role Description SAP America, Inc. seeks a Quality Specialist at our Newtown Square, PA location to ensure software quality through the design, development, and execution of comprehensive testing strategies, enabling compliance with organizational and industry standards. - Enhance software reliability, foster process improvement, and safeguard alignment with quality benchmarks. - Develop and execute test strategies, plans, and systematic tests to ensure software quality and compliance. - Document test results, ensuring transparency, and provide and monitor the implementation of corrective measures. - Consult and collaborate with cross-functional teams to integrate quality assurance into pipelines and processes. - Advise engineering teams on maintaining compliance with corporate requirements, as well as adhering to defined standards and processes. - Plan and support software audits to identify vulnerabilities and/or areas for improvement. Qualifications - Bachelor’s degree or foreign equivalent in Computer Science, Engineering, or a related field of study and five (5) years of progressive post-baccalaureate experience in the job offered or related occupation. - Alternatively, a Master’s degree or foreign equivalent in Computer Science, Engineering, or a related field of study and three (3) years of experience in the job offered or related occupation. Requirements - Experience must include two (2) years involving each of the following: - Programming including JAVA, Python, and Power shell; - Defect Management using Jira and Tests Management using Xray; - RESTFUL and SOAP API Testing using Postman, SoapUI, and Insomnia. - Experience must include one (1) year involving each of the following: - Automation Testing using frameworks like Selenium, Sauce Labs, Junit, and TestNG; - Source code or repository management with Git; - CICD implementation with Bamboo or Jenkins; - Database knowledge SQL, MYSQL, or Oracle; - Testing Cloud based application using Kubernetes. Benefits - Constant learning and skill growth. - Great benefits. - A team that wants you to grow and succeed.

Role Description It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. - Take ownership of assigned aspects of quality reviews on projects. - Compile metrics and identify quality trends. - Assist in addressing periodic client quality reviews and other ad-hoc client quality findings. - Prepare initial drafts of Corrective and preventive actions. - Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc. - Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). - Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. - Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers. - Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards. - Contribute to designing and tracking training schedule and training material for new hires and existing team. - Help initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects. - Assist in coordinating respective client or external audits of the assigned projects. - Draft sections of the Quality Management Plan for assigned project. - Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager. - Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. - Respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc. - Review recorded information that may be received over the telephone call, email, fax etc. - Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up. - Guide safety associates in managing voice calls (as required). - Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources. - Perform analysis of data and if required, suggest strategies for process improvement/excellence. - Perform and review analysis of data performed and drive strategies for process improvement/excellence. - All other duties as needed or assigned. Qualifications - Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Requirements - Three years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least one year of experience in Peer review/Quality review. - Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. - In-depth understanding of case processing and assessment. - Knowledge of Quality Assurance. - Aware of lean methodology concepts. - Technical proficiency with Microsoft Office suite of applications. Preferred Qualifications Include - Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred. - Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred. Physical Demands/Work Environment - Office Environment or remote. - Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.