120 Ich Guidelines Jobs - Page 3

As a Scientist at USP, your role will involve conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) utilizing suitable methods to enhance the laboratory's scientific proficiency and work ethic. You will offer extensive technical support and knowledge and provide valuable observations and insights into challenging projects. Your responsibilities will include: - Conducting verification projects (Dietary Supplements/Dietary Ingredients) by performing individual analytical tests such as HPLC, GC, Dissolution, ICP-MS, ICP-OES, and wet analysis as assigned - Completing projects within designated timelines and priorities - Demonstrating a robust sci...

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating exp...

As a Scientist Analytical R&D at Azurity Pharmaceuticals, you will be responsible for the execution of Analytical method development and support activities to meet Research and Development requirements. Your role will involve performing project-related literature search, developing various analytical methods for different formulation Dosage forms, and conducting forced degradation studies to identify unknown impurities. Additionally, you will participate in Method validation, method transfers, and verifications, while ensuring routine analytical testing for assigned projects. Key Responsibilities: - Perform project-related literature search and collect relevant information. - Develop analyti...

As a Statistical Programmer I, you will be responsible for creating, testing, and maintaining programs for clinical studies using SAS. Your key responsibilities will include: - Using SAS to generate summary tables, data listings, graphs and derived datasets as per statistical analysis plan and programming specifications. - Ensuring that outputs meet quality standards and project requirements. - Performing validation programming and collaborating with team members to resolve discrepancies. - Keeping project team members informed of programming progress and issues. - Following SOPs and relevant regulatory guidelines. - Maintaining well-organized project documentation and verification/quality c...

Description Safety & PV Trainee Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating...

Role Overview: You will be responsible for conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods in a non-supervisory role. As a Scientist at USP, you will enhance the laboratory's scientific proficiency and work ethic by providing extensive technical support and knowledge. Proficient in various common laboratory techniques, you will offer valuable observations and insights into challenging projects, aiding the Verification Program by executing analytical tests and preparing comprehensive summary reports. Key Responsibilities: - Conduct verification projects on Dietary Supplements/Dietary Ingredients by performing indiv...

As a Safety & PV Trainee at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. By entering information into PVG quality and tracking systems, processing ICSRs, and maintaining safety tracking, you will contribute to the accurate and timely reporting of safety data. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triaging ICSRs, evaluating ICSR data for complet...

Position Summary The Safety Specialist I is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Essential functions of the job include but are not limited to: Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability Enters data into Argus Safety Database Code events, medical history, concomitant medications and tests. Draft case narratives Assesses information to be queried and follows ...

Role Overview: As a GLP-Quality Assurance Personnel at Syngene International Limited, Bengaluru, you will play a crucial role in contributing to the GLP Quality Assurance Unit. Your primary responsibility will be to ensure compliance with OECD principles of Good Laboratory Practices (GLP), as well as ICH and WHO-GCLP guidelines. You will be tasked with handling inspections and audits, managing QMS activities such as change controls, deviations, and CAPA, and reviewing SOPs and study plans. Your core purpose in this role is to align laboratory practices with GLP guidelines to uphold the integrity and reliability of non-clinical safety and clinical studies. Furthermore, you will work in a regu...

Role Overview: As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Key Responsibilities: - Ensure accurate and timely processing of Ind...

Role Overview: As a Clinical Data Manager at Clinvigilant Research Pvt. Ltd., a company of GSC Group, located onsite in Ahmedabad, you will play a crucial role in managing and overseeing the data collected during clinical trials. With 3 to 6 years of experience in clinical data management or a related field, you will ensure the accuracy, integrity, and compliance of clinical trial data with regulations. Key Responsibilities: - Oversee the collection, management, and quality control of clinical trial data. - Develop, implement, and maintain the Data Management Plan (DMP) for clinical trials. - Design and build electronic data capture (EDC) systems and clinical databases in collaboration with ...

Role Overview: You will be working as an Executive - QC in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd. in Bangalore, India. Your main responsibility will be to review data for BA/BE studies in the laboratory, including checking method development, validation, and sample analysis data. You will report to the Head / Group Leader of the Small Molecule Bioanalytical Laboratory. Key Responsibilities: - Perform data checks (QC) for method development, validation, and study sample analysis. - Review STPs, Protocols, validation, and bioanalytical reports. - Ensure necessary documents and records are updated and ready for audits (Sponsor / Regulatory). - Handle ...

As a member of the Technical Operations team at Azurity Pharmaceuticals, you will play a crucial role in managing and overseeing technical process strategy, CMO and CDMO management, and the execution of product deliverables. Your dedication and expertise will contribute to the success of Azurity in providing innovative products to underserved patients. Here are the key responsibilities and qualifications required for this role: **Key Responsibilities:** - Manage the planning and execution of manufacturing for both development and commercial products, including qualification and validation activities. - Develop, review, and approve controlled documentation related to late-stage development, q...

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Job Responsibilities: Third Party Manufacturing (TPM) Site Compliance: Perform regular and ad-hoc visits to TPM facilities across the West Zone to evaluate compliance with current Good Manufacturing Practices (cGMP) primarily Revised Schedule M, Abbott's internal quality standards, and applicable regulatory guidelines. Identify non-conformities, process inefficiencies, and documentation gaps during site inspections. Collaborate with TPM quality teams to develop robust corrective and preventive action (CAPA) plans. Monitor CAPA implementation timelines and effectiveness through follow-up visits and reviews. Audit CAPA Oversight: Review audit findings from...

Description CRA II/ Sr CRA I (Mumbai Location, Client based) (Oncology) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate wit...

Description Step into the critical role of a Data Process Associate and contribute to the success of clinical trials by ensuring accurate and compliant data management. This role offers you the chance to develop key skills, work alongside experienced professionals, and build a strong foundation for your future in clinical research. If youre detail-focused and driven to support meaningful healthcare advancements, this is your opportunity to grow and make a difference. What You Will Do Accurately enter and verify clinical data from Case Report Forms (CRFs) into study databases following established guidelines. Perform quality control checks to ensure data integrity and compliance with regulato...

As a Safety Specialist I at Precision, your role will involve performing all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Key Responsibilities: - Process ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability - Enter data into Argus Safety Database - Code events, medical history, concomitant medications, and tests - Draft case narratives - Assess information to be queried and follow up until queries are satisfactorily resolved - Generate timely, consistent, a...

Description At Quanticate, we&aposre pioneers in providing top-tier statistical and data management support to our clients. We&aposre seeking a dedicated "Clinical Data Manager I" who&aposs committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient ru...

You are a detail-oriented RA-CMC Associate responsible for supporting end-to-end submissions for global markets. Your expertise includes Lifecycle Management (LCM), Veeva Vault RIM, and managing complex Initial and Variation submissions. Your key responsibilities will involve preparing Variation documents and/or evaluating post-approval CMC changes to ensure compliance with global regulatory requirements. You will play a significant role in Lifecycle Management (LCM) activities by assisting in compiling and reviewing CTD dossier modules. Your tasks will also include compiling initial dossiers (Modules 2 & 3) for various countries such as US, EU, SA, WHO, ANZ, and others. You will be expected...

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As part of our EY-ER- Regulatory Compliance team, you will help clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Associate Director, you will actively establish, maintain, and strengthen internal and external relationships. In line with our commitment...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

The role of Line Manager at the company involves overseeing and managing the Performance and Safety Services (PSS) staff, including conducting performance reviews, handling human resource issues, and collaborating with Senior PSS Management on resource allocation for projects. The primary responsibility of the Line Manager is to provide guidance and support to junior PSS staff members. This includes managing, coordinating, and supervising PSS operations related to adverse events and expedited safety reports to ensure compliance with standards and timely submission to clients and regulatory agencies if required. The Line Manager is also expected to support team members in delivering high-qual...

The Technology Transfer Associate is responsible for coordinating and executing the seamless transfer of pharmaceutical products to Ritsa manufacturing Facility from client /R&D or result in any merger or acquisition. This role will oversee the planning, execution, and completion of projects with end-to-end accountability for deliver in time This role ensures that all processes (analytical and manufacturing) are effectively transferred while maintaining compliance with regulatory requirements, quality standards, and operational efficiency. Key Responsibilities: Project Planning and Execution Define project scope, objectives, deliverables, and timelines. Develop detailed project plans, alloca...

As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality...