87 Quality Review Jobs - Page 2

Completes audits to ensure claim advocates understanding of current Cigna policies and procedures, including job aids, Articles, and alerts.This includes claim processing guidelines, regulatory requirements, contractual benefits, and specific customer circumstances. Understanding of the appropriate application of claim and other directional documents/tools is a key component of the quality assurance auditing process. Interfaces with matrix partners in relation to quality audit process, specifically address gaps identified through audit process and recommendations for gap closure. Completes review of documents related to audits to help ensure direction is clear and consistent with processing of work.Provides feedback to operations where updates may be required to drive consistency and accuracy. Completes inter-rater reliability exercises with peers, other quality roles and business owners to provide insight into review process. Understanding of the appropriate standard operating procedures and other directional documents/tools is a key component of the quality assurance auditing process. Provides a quality review voice in various workgroups pertaining to workflows, documentation and issues driving errors, in an attempt to continuously improve results. Supports, educates, and reinforces the workflows, processes, tools for the nurses. Provides support for internal and GSP sites based on business needs. Support Coaching and Training program and responsibilities when needed to Support for Business needs and requirements which could include answering Q&A, facilitate trainings, and Coaching. Qualifications: Overall 5+ years of experience in Healthcare Claim Adjudication process (in that min 1.5 years of auditing experience). US & International claims experience preferred. At least 1+ year Diamond claim processing experience required. Customer Service Driven; ability to meet and exceed the internal partner and external customer expectations. Proven outcomes in critical thinking and decision-making outcomes. Proven outcomes in problem solving skills; utilization of technical skills and resources to ensure accuracy of final resolution. Proven process improvement skills: ability to assess trends, processes, and barriers to drive positive outcomes for claim resolutions. Must be comfortable and effective working in a diverse environment; office and/or virtual environment (if any). Strong organization and time management skills; effectively adapts to multiple and/or competing priorities. Strong communication skills, both verbal and written; ability to adapt communication to the individual or audience.

Job Description Summary Product quality review associated with the manufacturing process. Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance. Job Description Roles and Responsibilities Verify conformance to specification by measuring and testing during in-house manufacturing. Perform incoming goods control product inspections witness points to control quality for items from external suppliers. Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members Required Qualifications BE - Electrical / Mechanical having more than 12-15 years of experience in Transformer Manufacturing Industry in In process Quality Handling customer inspection & managing a team of 8-10 engineers and technicians Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document plan market and execute programs. Established project management skills. Additional Information Relocation Assistance Provided: Yes

Overview *Accurately label and annotate data (images, video, audio, or text) using internal tools and guidelines. *Follow detailed instructions and predefined annotation guidelines for consistency and quality. *Review, validate, and correct existing annotations as needed. *Collaborate with QA teams to ensure high-quality output. *Report inconsistencies or issues in data or tools. *Meet daily/weekly targets for volume and accuracy. *Suggest improvements to annotation processes and guidelines. Before applying for this position you need to submit your online resume . Click the button below to continue. About ZST outsourcing services pvt. Ltd We are seeking detail-oriented and highly motivated Data Annotation Specialists to support our machine learning and AI initiatives. In this role, you will label, categorize, and annotate data (such as images, video, text, or audio) to train and improve artificial intelligence systems. This work plays a critical role in ensuring data accuracy and model performance. Freshers Are also welcomed.

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team in the Chennai location. The Senior Clinical Data Manager I (SrCDM1) will be responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, your key tasks will include leading and serving as the primary contact for DM with all relevant parties both internally and externally, planning and projecting the resources required, monitoring tasks against budgets and forecasts, and developing, reviewing, and maintaining project-specific DM documents. You will also lead and coordinate the development of clinical study database set-up, participate in the review of study documents, coordinate database User Acceptance Testing (UAT), create training materials for EDC users, oversee data cleaning and validation, and manage various data transfers and reconciliation activities. Additionally, you will provide project metric reports, status updates, study progress, and feedback to the project team, organize and lead Quality Review activities during the study, assist in project-related contracts negotiation, and manage the database maintenance, lock, and close-out processes. You will also participate in conference calls and meetings with vendors and sponsors, maintain DM study documentation, support internal and external audits, align data management and clinical programming best practices, and provide leadership and support to other department members. To be successful in this role, you should possess a life science or healthcare degree, a minimum of 5 years of relevant work experience as a Clinical Data Manager, thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and experience with electronic data capture software systems. You should also have experience as a DM lead on several studies, strong written and verbal communication skills, strong project management skills, and the ability to simplify complex issues into understandable concepts. Benefits of working at Allucent include a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, opportunity for remote/office-based working, leadership and mentoring opportunities, internal growth opportunities, access to online training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program. Please note that office-based employees are required to work in-office for a minimum number of days per work week. Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,

. Level 3 SOC Responder Role Overview: A Level 3 SOC Analyst is responsible for advanced threat detection, incident response, and continuous monitoring of security events. They lead investigations, coordinate responses, and mentor junior analysts, ensuring the security and integrity of information systems. Key Responsibilities: Lead the investigation and response to complex security incidents, including advanced persistent threats (APTs), malware outbreaks, and insider threats Liaison between SOC and customer Incident response team to handle complex incidents Document security incidents, investigative findings, and remediation activities in accordance with established incident response procedures and protocols Suggest SIEM rule finetuning to reduce false positive alerts Develop standard operating procedures (SOPs) Perform quality review of the alerts handled by L1 and L2 Track KPIs and create dashboards for executive briefing Provide guidance and mentorship to junior SOC analysts, imparting knowledge and best practices in incident detection, analysis, and response. Conduct training sessions and workshops to enhance the skills and capabilities of SOC team members Skills and Qualifications: Education: Bachelor s degree in Cybersecurity, Information Technology, Computer Science, or a related field. Experience: 7+ years of experience in SOC operations, incident response, and threat hunting. Experience in CrowdStrike SIEM and EDR preferred. Certifications (Preferred): Relevant certifications such as CISSP, CEH, GCIH, or similar. Problem-Solving Skills: Excellent problem-solving skills and attention to detail. Communication Skills: Strong communication skills, both written and verbal. Work Environment: Typically works in a security operations center. May require shift work to provide 24/7 monitoring.

0 to 10 years of relevant experience in medical transcription Job Description : Role Overview: Join our dynamic and growing team at Ecorgy Solutions as a Medical Transcriptionist, where your expertise will help convert critical clinical content into structured and accurate electronic health records (EHRs). This role is instrumental in supporting our Clinical Quality Review Team, ensuring every document aligns with internal quality standards and US healthcare compliance protocols. You ll work closely with clinical documentation sourced from Registered Nurses (RNs), Physical Therapists (PTs), Occupational Therapists (OTs), and other allied health professionals, ensuring clarity, accuracy, and timeliness in medical records. Requirements: Bachelor s degree in any discipline. 0 to 10 years of relevant experience in medical transcription. Proficiency in English (spoken and written) with strong grammar and comprehension skills. Sound understanding of medical terminology, home healthcare concepts, and clinical workflows (preferred). High attention to detail and ability to work independently under tight deadlines. Proficient in typing, Microsoft Word, and EHR platforms (preferred). Strong sense of responsibility, integrity, and ownership of deliverables. Why Join Us? Employee Benefits: EPF and ESI/Group Mediclaim policy after 6 months of employment Gratuity benefits in line with employment tenure Growth & Recognition: Rewards and career advancement based on performance Professional development & upskilling programs On-the-job training and expert mentorship Work Culture: Supportive team environment Opportunity to work in a healthcare process aligned with global standards Career path in the ever-growing US healthcare industry How to Apply? Ready to be a part of a company that values precision, growth, and integrity? Send your updated resume to: careers@ecorgysolutions.com

Vizen Lifesciences is seeking a dedicated Medical Information Call Center (MICC) Team Lead, ,Quality Reviewer, and Associates to join our team. The ideal candidate should have an educational background in B.Pharm, M.Pharm, or Nursing , with 0 to 15 years of relevant experience in a MICC environment. This role requires excellent English language skills , proficiency in understanding the US accent , and the flexibility to work in 2pm to 10 PM shift Key Responsibilities: Handle inbound and outbound calls, document them, and perform follow-up calls as per client requirements and SOPs. Ensure compliance with Vizen Lifesciences and client quality requirements. Send completed documents for QC in hourly reports. Follow telephone etiquette in the MICC process. Refer to safety reference and client-provided documents while handling calls. Manage test calls, faxes, voicemails, and emails. Categorize call information into product complaints, AE/SAE, medical queries, and product quality complaints. Forward AE/SAE information to the pharmacovigilance department and product complaints to the QA department as required. Contact manufacturing units or clients regarding medical inquiries with unavailable information. Adhere to administrative, technical, and physical safeguards to protect all data, ensuring confidentiality, integrity, and availability. Handle respective trackers and perform reconciliation. Ensure adherence to client-specific SOPs for all activities. Attend training and client meetings as needed. Provide feedback and training to team members. Archive pharmacovigilance documents. Education Qualifications requirement: Bachelors or Masters degree in Pharmacy or Nursing. Experience required: 0 to 15 years of relevant experience in Medical Information Call Center (MICC) Team Leads and ,Quality Reviewer positions require additional leadership or quality review experience Mandatory Requirement: Excellent English language speaking and writing skills.

Description About LegalZoom As the industry leader for over 20 years, innovation remains at the center of all we do. Were creative thinkers and problem solvers with a passion for building legal and tax products that make a positive impact on the world, and were always looking for exceptional people to push us further. At LegalZoom.com, Inc. we have transformed the legal industry with the launch of our cloud-based services and groundbreaking technology. Millions of customers have counted on us to officially start and run businesses, protect brands and intellectual property, and look after loved ones through wills and trusts. Were here to make legal help accessible to all. With us, youll do work thats as rewarding as it is challenging with a team where every voice matters and diversity, equality, and inclusion are truly embraced. Together, well continue to democratize the law and make a real difference in the lives of millions. About the Role: We are seeking a motivated Procurement Specialist to join our dynamic team at LegalZoom. The ideal candidate will have 1-3 years of experience in procurement and will be responsible for negotiating lower-dollar sourcing contracts, working with stakeholders to support projects, and driving cost savings. Key Responsibilities: Proactively collaborate with business partners and stakeholders to lead contract negotiation with suppliers; develop negotiation approaches, fallback positions and acceptable terms and conditions through completion and identifying key benchmarks to measure contractual arrangements. Establish and maintain effective partnerships with key stakeholders aimed at identifying, understanding and fulfilling their requirements to meet key business objectives. Identify cost savings opportunities and manage cost reduction activities to achieve annual cost savings and cost avoidance goals without compromising relationship integrity, supply assurance or quality. Review existing contracts and gather business requirements to formulate sourcing strategies and planning for renewals. Perform spend analysis to help develop and implement category strategies. Ensure compliance with procurement policies and procedures. Qualifications : 1-3 years of experience in procurement experience with indirect purchases. Strong negotiation skills and experience with contract management. Excellent communication and interpersonal skills. 1 Strong analytical skills and understanding of fundamental financial concepts Ability to work independently and as part of a team. Demonstrated ability to work effectively managing multiple projects with minimal supervision.

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis Co ordination with Collection and Sales Team for Delinquency Management . Co ordination with Central Ops team and internal audit team to ensure process, policy adherence is implemented and audit observations are rectifies and complied. Ensure effective utilization of System reports for various analysis pertaining to product, credit parameters. Manager third Party Vendors , verification agencies for various types of verification .

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Followings will be the Core Job Responsibilities of the position holder: 1. Preparation, Issuance, Retrieval & archival of Mastet documents SOP (Forms & Records), Spec & STP (RM, SFG & FG) and other Master documents (List, SMF, VMP, Quality Manual), Master Lists. 2. DARIUS - Software Handling and Compliance 3. Master List SOP, Spec & STPs etc. 4. Issuance of requested Uncontrolled Master documents for closure of CCP/ Exception & requested by cross function department outside the Plant for Reference Purpose. 5. Controlling of General Document Number. 6. To ensure documentation of out of specification, Exception, and Change Control. 7. To ensure the effective implementation of QMS through SolTRAQs application system. 8. To ensure the effective artwork through harmony. 9. Preparation of Maximum Retail Price List. 10. Annual Product Quality Review Preparation of Annual Product Quality Review as per SOP timelines and to identify the improvement areas or recommendations. 11. To perform CAPA effectiveness check activity related to Audit Compliance CAPAs. 12. Preparation for the Training Materials, Coordination with the cross functions for the execution of the trainings as per plan. 13. Updation of the Employee, courses, modules, and other amendments in ISOtrain system. 14. Past due trainings follow up and reconciliation. 15. Maintaining the records of GMP/Technical training and QA department training. 16. To follow all the practices related to Safety and COBC. 17. All miscellaneous activities as assigned by seniors. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working. JOB FAMILY: Operations Quality t

Summary: Technical expert with depth or breadth of knowledge within Quality Review and Audit. Applies standard techniques and procedures to routine instructions but requiring professional knowledge in specialist areas. Provides standard professional advice and creates initial reports/analyses for review. Develops and distributes audit reports. Assists with third party audits by completing questionnaires, validating selected claims, responding to errors, etc. Identifies and recommends changes to improvements in department processing and procedures and assists in the development of audit guidelines. May develop and/or recommend training programs to address error trends. Provides guidance, coaching, and direction to more junior team members of the team. Acts independently working under limited supervision. Job Location: Bengaluru, India (Work from office) Work Shift: US Shift - 17:00 to 02:00 IST Responsibilities: Completes audits to ensure claim advocates understanding of current Cigna policies and procedures, including job aids, Articles, and alerts. This includes claim processing guidelines, regulatory requirements, contractual benefits, and specific customer circumstances. Understanding of the appropriate application of claim and other directional documents/tools is a key component of the quality assurance auditing process. Interfaces with matrix partners in relation to quality audit process, specifically address gaps identified through audit process and recommendations for gap closure. Completes review of documents related to audits to help ensure direction is clear and consistent with processing of work. Provides feedback to operations where updates may be required to drive consistency and accuracy. Completes inter-rater reliability exercises with peers, other quality roles and business owners to provide insight into review process. Understanding of the appropriate standard operating procedures and other directional documents/tools is a key component of the quality assurance auditing process. Provides a quality review voice in various workgroups pertaining to workflows, documentation and issues driving errors, in an attempt to continuously improve results. Supports, educates, and reinforces the workflows, processes, tools for the nurses. Provides support for internal and GSP sites based on business needs. Support Coaching and Training program and responsibilities when needed to Support for Business needs and requirements which could include answering Q&A, facilitate trainings, and Coaching s. Qualifications: Overall 5+ years of experience in Healthcare Claim Adjudication process (in that min 1. 5 years of auditing experience). US & International claims experience preferred. At least 1+ year Diamond claim processing experience required. Customer Service Driven; ability to meet and exceed the internal partner and external customer expectations. Proven outcomes in critical thinking and decision-making outcomes. Proven outcomes in problem solving skills; utilization of technical skills and resources to ensure accuracy of final resolution. Proven process improvement skills: ability to assess trends, processes, and barriers to drive positive outcomes for claim resolutions. Must be comfortable and effective working in a diverse environment; office and/or virtual environment (if any). Strong organization and time management skills; effectively adapts to multiple and/or competing priorities. Strong communication skills, both verbal and written; ability to adapt communication to the individual or audience. About The Cigna Group

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: Responsible for performing quality control (QC) review of clinical research imaging across a range of therapeutic areas and imaging modalities, verifying compliance with trial-specific protocol parameters, and ensuring data is of suitable quality for assessment and quantitative analysis. This review includes verification of compliance with trial and site-specific imaging requirements, review of anatomical coverage, identifying the presence of artifacts which may prevent accurate image interpretation and analysis, and imaging data reconstruction and processing. Job Duties: Perform technical quality review of medical imaging (e.g., PET, SPECT, MRI or CT, gamma counting data). Imaging data reconstruction and processing. Completion of quality control (QC) documentation according to good clinical practice and regulatory guidelines. Collaborates across functional groups within the Core Lab to ensure high standards of data collection are maintained and project deliverables are successful. Education/Experience: Medical imaging professional with 3+ years of technical imaging experience and/or certified medical imaging technologist (NMTCB, ARRT, etc.) in Nuclear Medicine, PET, MRI and/or CT. Technical knowledge and experience with nuclear medicine/PET imaging Excellent verbal and written communication skills Ability to work collaboratively with customers and team members Strong attention to detail Should be process focused for ensuring efficient follow-through of internal procedures Qualifications: Strong understanding of radiological imaging Must possess strong written and verbal skills for effectively communicating with departmental staff and research centers Strong computer skills including competency across a variety of computer applications and systems Ability to work collaboratively with customers and team members Relevant experience should exhibit organizational capabilities and strong attention to detail Should be process focused for ensuring efficient follow-through of internal procedures. Come as you are.

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: Responsible for performing quality control (QC) review of clinical research imaging across a range of therapeutic areas and imaging modalities, verifying compliance with trial-specific protocol parameters, and ensuring data is of suitable quality for assessment and quantitative analysis. This review includes verification of compliance with trial and site-specific imaging requirements, review of anatomical coverage, identifying the presence of artifacts which may prevent accurate image interpretation and analysis, and imaging data reconstruction and processing. Job Duties: Perform technical quality review of medical imaging (e.g., PET, SPECT, MRI or CT, gamma counting data). Imaging data reconstruction and processing. Completion of quality control (QC) documentation according to good clinical practice and regulatory guidelines. Collaborates across functional groups within the Core Lab to ensure high standards of data collection are maintained and project deliverables are successful. Education/Experience: Medical imaging professional with 3+ years of technical imaging experience and/or certified medical imaging technologist (NMTCB, ARRT, etc.) in Nuclear Medicine, PET, MRI and/or CT. Technical knowledge and experience with nuclear medicine/PET imaging Excellent verbal and written communication skills Ability to work collaboratively with customers and team members Strong attention to detail Should be process focused for ensuring efficient follow-through of internal procedures Qualifications: Strong understanding of radiological imaging Must possess strong written and verbal skills for effectively communicating with departmental staff and research centers Strong computer skills including competency across a variety of computer applications and systems Ability to work collaboratively with customers and team members Relevant experience should exhibit organizational capabilities and strong attention to detail Should be process focused for ensuring efficient follow-through of internal procedures. Come as you are. Were proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Job Description Associate/Senior Associate, GSC Document Delivery Hub, LCCI Purpose: The purpose of this role is to support the Global Scientific Communications team to produce documents of high quality. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. 1. Scientific Communications Document Support Editing and Quality Review : -Ensure timely delivery of error-free, high-quality regulatory and publication documents that meet international standards of written English. - Correct errors in grammar, style, formatting, and syntax. Identify and fix flaws in logic and flow. - Follow style guides/templates provided by the team. - Follow best-practice based on Lilly internal standards. - Verify data against source files, ensure accuracy and consistency of data and content within and between related documents. Document finalization/publishing services : - Produce final eCTD-compliant PDFs of medical regulatory documents using publishing software - Review and format Word files to ensure as many compliance requirements are in the source file as possible. - Render the Word files into PDFs. - Review the PDFs and edit them as needed to ensure all regulatory requirements are met. General expectations - Maintain a strong customer focus. - Accountable for achieving timelines by managing activities efficiently and proactively; utilize ability to understand and apply team communication strategies to work products. - Coach new Specialists or others requiring development in core areas. - Coordinate with vendors if any of the aforementioned activities are outsourced. 2. Process efficiency and technology advancement Maintain proficiency in applicable software, tools, processes, and workflows. Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to streamline team workflow. Improve document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize redundancy between databases and other tools. 3. Therapeutic & Disease State Management Understand key priorities and communication strategies across therapeutic areas and/or organizational units. Maintain a working knowledge of product and disease state information. Continue to develop therapeutic knowledge and be familiar with trial design, rationale and data. Apply this knowledge in activities listed above. Minimum Qualification Requirements: Bachelors degree Strong written and verbal communication skills in English. Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues, external vendors and customers. Demonstrated project management and time management skills. Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability. Interpersonal skills and the ability to be flexible in varying environments. Ability to utilize high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates). Ability to work well independently and as part of a team, within and across culturally and geographically diverse environments. Proven ability to assemble, share and apply key learnings across multiple projects. Other Information/Additional Preferences: Specialized knowledge of editing & proofreading tools and techniques BELS certified professional Knowledge of medical and statistical terminology; willingness to expend effort in acquiring scientific knowledge and understand strategic issues General knowledge of scientific literature search and retrieval Limited travel, up to approximately 10% . .

Career Category Safety Job Description This position plays a role in the authoring, compilation and peer review of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment Drive report timelines and escalate risks or delays to team leads or management Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process. Review and approve published report versions (i. e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Literature Management Process May assist with Literature Management activities as required Basic Qualification and Experience: Master s degree or Bachelors degree with 5 years of experience .

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis

Manage over all Credit Underwriting process for the respective State or Multiple States . Portfolio Management , Quality Review on periodical basis. Maintain expected service TAT . Initiate Training Program on Programs, underwriting skills , customer level. analysis