5 Clinical Review Jobs

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,

The role of the Medical Officer based in Vadodara, India involves reviewing and verifying large volumes of patient's full medical records with precision. You will be responsible for performing clinical reviews as per specific methodologies and preparing detailed reports including chronologies, timelines, summaries, mass tort matrix, and medical opinions on case validity and valuation. Your key responsibilities will include analyzing and summarizing medical records for pre and post-settlement projects, interpreting clinical data using medical terminology and diagnosis, and adhering to company policies and ARCHER principles to maintain the Archer culture. It is essential to comply with the Health Insurance Portability and Accountability Act (HIPPA) at all times and provide daily reports to the Medical Team Lead on productivity and quality. In terms of technical skills, you should have a basic understanding of healthcare data analysis and clinical review, sound knowledge of medical terminology, assessments, patient evaluation, and clinical medicine. Proficiency in using Microsoft Word, Adobe, and Excel is required. Interpersonally, you should be able to work effectively in a team environment with staff at all levels to achieve business goals. The ability to perform under pressure, meet deadline-oriented project demands, manage multiple initiatives, and demonstrate effective communication skills are also crucial. Being detail-oriented, organized, and a motivated self-starter is essential for success in this role. No prior experience is required for this position. A degree in MBBS is necessary. Additional skills such as knowledge of HIPPA regulations, critical thinking, basic understanding of US culture, and organization culture and behavior will be beneficial. This is a permanent position within the operations department, reporting to the Medical Team Lead.,

As a Nurse Practitioner in the BPO (Healthcare) industry located at Infopark, Kakkanad, Kochi, you are required to have a minimum of 2 years of clinical experience. The role entails working the Night Shift from 6PM to 3AM with a monthly salary ranging from 30,000/- to 40,000/-. Fluency in English is a necessity for effective communication. Your responsibilities will include providing a comprehensive clinical review of complaints and appeals from providers, ensuring cost-effective delivery of health services by adhering to appropriate resources and guidelines. You will support the identification and review of suitable case types as per clinical guidelines, promoting quality effectiveness of Healthcare Services. It is crucial to accurately apply review requirements to guarantee that cases are reviewed by practitioners with the relevant clinical expertise. Additionally, the role requires the ability to interpret clinical laboratory results, be familiar with clinical conditions, and their management. The qualifications needed for this position include a Bachelor of Science in Nursing and a minimum of 18 months of clinical experience. Fluency in English is also a mandatory requirement. The willingness to work in shifts, particularly the Night Shift from 6PM to 3AM, is essential. The benefits provided for this role include Cab (pickup & Drop), Employee Stock Ownership, Provident Fund, Health Insurance, and a basket of allowances. This is a Full-time, Permanent position. Furthermore, additional benefits encompass Commuter assistance, Life insurance, and Yearly bonuses. The work schedule involves Fixed shifts from Monday to Friday, including Night and US shifts with Weekend availability. Shift allowances are provided along with other benefits. The educational requirement for this role is a Bachelor's degree, with a minimum of 2 years of experience in Clinical Nursing. A BSc Nurse license/certification is also mandatory. Night Shift availability is a requirement for this position, and the work location is in person.,

Roles and Responsibilities Entering of patient demogrpahics and insruance information. Verifying Insurance Policy coverage from the webportal. Order Corrections for the screnrios : Changes in the calories, different product, Hospital Re-admit, discharge, patient expired. Delivery Worksheet : Orders are being picked from the Patient Medical records Monthly facility billing (PART A Report ) and MA reports are prepared and sent to the client. Develop understanding of client specifics and requirements File are split and renamed as per the client naming convention. Renamed Invoices are allocated to the users for further tasks Based on the Invoice, users should reconcile or enter the PO in the accounting application. Following up with clients on Invoice clarification Understand special situations and procedures that relate to the client we work on. Performs other duties as assigned. Desired Candidate Profile Education, Training, and Experience Required: Bachelors Degree or 3 year Diploma or equivalent is required. Medical Transcription experience is a huge plus Two (2) years of Medical Billing DME Billing, Charge Entry, Payment Entry experience is preferred; Equivalent combination of experience, education, and training that would provide the required knowledge and abilities. Knowledge/Skills: Knowledge of medical terminology; anatomy and ; English grammar and usage. Ability to research and analyze data, draw conclusions, and resolve issues; read, interpret, and apply policies, procedures, laws, and regulations. Ability to read and interpret medical billing clinical notes Ability to develop training materials, make group presentations, and to train staff Ability to exercise independent judgment; Excellent written and verbal communication skills to prepare reports and related documents and to maintain working relationships with physicians and other staff. Ability to competently use Microsoft Office Suite, particularly Word, Excel and Outlook. Ability to maintain confidentiality. Perks and Benefits As per market standards

Position Reports To : Medical Team Lead Department : Operations Position Summary : - The role will be to review and verify large volumes of patient's full medical records with precision, perform clinical reviews as defined by the specific review methodologies and prepare a detailed report that includes chronologies and timelines, summaries, mass tort matrix and medical opinions on case validity and valuation. Job Responsibilities : - Analyzing and summarizing medical records for pre and post settlement projects. Interpreting clinical data in terms of medical terminology and diagnosis. o Adhering to company policies/ARCHER principles and hence taking good care of Archer culture. Adhere to Health Insurance Portability and Accountability Act (HIPPA) all the time. Daily reporting to Medical team lead for productivity & quality Knowledge, Skills And Abilities : - Technical Skills: Knowledge of basic level of health care data analysis and clinical review. o Sound knowledge of medical terminology, assessments, patient evaluation, and clinical medicine. Ability to work proficiently with Microsoft Word, Adobe, and Excel. Interpersonal Skills: Ability to perform well in a team environment, with staff at all levels, to achieve business goals. Ability to function under pressure and with deadline-oriented project demands as well as manage multiple initiatives. Team player and motivated self-starter. o Detail-oriented, organized, able to multi-task. Effective communication skills. Educational Qualification And Experience Required : - MBBS graduate (No experience required) BHMS/BAMS graduate (Minimum 2 years of experience with Claims Processing in the Insurance sector). Additional Skills : - HIPPA, Critical thinking, Basic understanding of US culture, Basic understanding of organization culture and behavior. Career Path : - Medical Officer Medical Team Lead