4 Ema Guidelines Jobs

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. - Perform clinical data management activities. - Handle and process patient reports efficiently. - Ensure data quality and integrity during the entry and annotation process. Requirements - Qualification: B.Sc, M.Sc, B.Pharma, or M.Pharma. - Minimum 1 year of experience in medical data annotation and medical document review. - Mandatory experience working night shifts (US shift: 10:00 pm to 7:00 am). - Experience with FDA, EMA, ICH, and GCP guidelines. - Proficiency in Clinical Data Management and handling Patient Reports. - Only candidates with a medical background and medical data annotation experience will be considered. - Immediate joiner preferred. Technical Requirements - Laptop or Desktop: Windows (i5 or higher, 8GB RAM minimum) - Screen: 14 inches, Full HD (1920*1080) - Internet Speed: 100 Mbps or higher About ARDEM ARDEM is a leading Business Process Outsourcing and Business Process Automation service provider with a strong track record of delivering exceptional services to clients in the USA and Canada for over twenty years. We are dedicated to innovation and excellence in providing the best Business Process Outsourcing and Business Process Automation solutions to our customers. Note ARDEM prioritizes the security and privacy of all applicants and will never ask for personal or banking information during the hiring process for any data entry or processing work. If you are contacted by any party claiming to represent ARDEM Incorporated offering work-from-home jobs, please disregard and refer to ARDEM's Careers page for all open job positions. We apologize for any inconvenience caused by such fraudulent acts.,

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial. Additionally, familiarity with project management tools like Jira and Confluence is necessary to collaborate effectively with cross-functional teams. An advanced knowledge of R, HTML, and GitHub will further support your role in this dynamic environment.,

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,