169 Ich Guidelines Jobs - Page 2

As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk manag...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Job Description Description: Summary: (optional) This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a team member for individual case safety report processing and as case owner for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting. Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned. .Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter's causality...

Job Overview Assist with the overall Clinical Safety and/or PSS 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 process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and co...

Job Overview 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. Summary Of Responsibilities Perform Quality review of assigned cases. Assist in compiling quality metrics based on this review and identifying quality trends. Assist in addressing periodic client quality reviews. Assist in preparation of Corrective and preventive ac...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

Role Overview: As an ARD Chemist / Scientist at the Udaipur location, you will be a key member of the ARD team, focusing on method development, impurity profiling, and instrumental analysis to support Synthesis R&D and quality operations. Your primary responsibilities will include developing and validating analytical methods, performing impurity profiling, and maintaining analytical instruments. Key Responsibilities: - Develop and validate HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples - Develop HPLC methods suitable for Analytical Method Validation (AMV) and transfer to QC - Perform impurity profiling of APIs and intermediates using advanced techniques lik...

As the Quality Control Head at Celogen Pharma Pvt. Ltd., you will be responsible for directing all laboratory operations related to testing of raw materials, packaging materials, in-process materials, and finished pharmaceutical products. Your role will involve ensuring strict compliance with current Good Laboratory Practices (GLP) and all applicable national and international regulatory standards to provide high-quality, timely analytical support for manufacturing and product release. **Key Responsibilities:** - **Analytical Testing:** - Perform routine and non-routine analytical testing using various techniques such as HPLC, KF, Dissolution, Titration, and Physical testing. - Ensure testin...

Role Overview: As a Senior Medical Writer at Syneos Health, you will play a crucial role in ensuring the clear and accurate completion of medical writing deliverables. You will lead the completion of various documents such as clinical study protocols, reports, patient narratives, and more, while adhering to established regulatory standards. Your responsibilities will include coordinating quality and editorial reviews, interacting with clients and peers, and mentoring less experienced writers. Your focus will be on delivering high-quality medical writing services within budget specifications. Key Responsibilities: - Lead the clear and accurate completion of medical writing deliverables, ensur...

Company Description NexGen Pharma Solutions is a global pharmaceutical consulting firm specializing in GMP compliance, regulatory affairs, and quality management. Headquartered in Vadodara, Gujarat, India, the company serves clients across India, China, and other emerging markets with services including third-party GMP audits, quality management system implementation, process validation, and regulatory support. NexGen's team of experienced professionals ensures that pharmaceutical manufacturers adhere to international regulations such as USFDA, EU GMP, and WHO GMP standards. With a mission to empower businesses to operate ethically and efficiently, NexGen focuses on enabling continuous impro...

As a Report Writer, your role involves preparing high-quality scientific and technical reports, such as clinical study reports (CSRs), bioanalytical reports, and regulatory submission documents. You are responsible for ensuring that all reports adhere to regulatory guidelines, industry standards, and internal SOPs while effectively communicating scientific findings. Key Responsibilities: - Prepare and review various scientific and technical reports, including clinical study reports, bioanalytical reports, and method validation reports. - Ensure clarity, accuracy, and compliance of reports with regulatory requirements such as FDA, EMA, ICH, Good Clinical Practice (GCP), and Good Laboratory Pr...

Overview The Principal Medical Coder is responsible for overseeing centralized medical coding / SAE activities and managing a team of Medical Coders. Highly proficient and detail-oriented specializing in accurately coding complex medical data from clinical trials, ensuring compliance with regulatory standards and industry guidelines. Acts as MedDRA and WHODrug SME for coding teams and cross functional study team stakeholders. Adept at collaborating with clinical and data management teams to streamline coding processes and improve operational efficiency. Committed to continuous professional development and staying current with evolving medical terminologies and coding systems to maintain the ...

Roles & Responsibilities Regulatory Submissions & Filings Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.). Ensure submissions are complete, accurate, and in CTD/eCTD format. Coordinate with internal teams to gather technical and manufacturing data for filings. Track submissions, approvals, and queries from regulatory authorities and ensure timely responses. Dossier Preparation & Maintenance Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements. Update existing dossiers to reflect process or analytical changes. Review and compile CMC (Chemistry, Manufacturing & Controls)...

As a LifeScience Regulatory Services Associate at Accenture, you will be part of the Life Sciences R&D vertical, contributing to regulatory services for leading biopharma companies. Your role will involve performing regulatory affairs LCM with Veeva skill set, submission in accordance with ICH guidelines, and reviewing and transforming source documents. Additionally, you will be responsible for performing Quality Control checks for all submission components, collecting and evaluating scientific data, advising on legal and scientific requirements, and ensuring compliance with current regulations. Key Responsibilities: - Perform regulatory affairs LCM with Veeva skill set of submission in acco...

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

As a Regulatory Affairs Manager for biologic products, your responsibilities will include: - Developing global regulatory strategies for biologic products throughout all development phases in the US, EU, and rest of the world, ensuring alignment with business objectives and regulatory requirements in different regions (FDA, EMA, emerging markets). - Preparing, reviewing, and managing high-quality regulatory submissions such as INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, and post-approval changes (variations, amendments). - Engaging with global regulatory agencies to support product approvals and address inquiries, collaborating with R&D, Quality, Clinical, and national regulatory teams t...

Job Responsibilities Formulation Design & Development Design and develop robust, scalable formulations for oral solid dosage forms (OSDs) including tablets, capsules, and granules. Select appropriate excipients, processing techniques (e.g., direct compression, wet/dry granulation), and equipment. Develop formulations that meet target product profiles (QTPP), including bioavailability, stability, and manufacturability. Pre-formulation & Compatibility Studies Conduct pre-formulation studies to evaluate properties such as solubility, hygroscopicity, flow, and compressibility. Perform drugexcipient compatibility studies using thermal and analytical methods (e.g., DSC, FTIR). Experimental Batch E...

Summary Design, plan, perform, interpret and report the analytical results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within global ARD. Expertise in analytical method development, method validation as well as technical and strategic background. Manage technical lab/plant activities. Execute the analytical experiments in line with TRD vision. Ensure full portfolio support in line with GDD, NTO and NIBR plans. Maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned. About The Role Major accountabilities: Provide analytical and technical support to PHAD/...

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

Summary Design, plan, perform, interpret and report the analytical results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within global ARD. Expertise in analytical method development, method validation as well as technical and strategic background. Manage technical lab/plant activities. Execute the analytical experiments in line with TRD vision. Ensure full portfolio support in line with GDD, NTO and NIBR plans. Maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned. About The Role Major accountabilities: Provide analytical and technical support to PHAD/...

Description Sr CRA I (Oncology/Ophthalmology) 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 solve...

Job Responsibilities To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to e...

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

Description Sr Safety Specialist (Literature Review) 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 proble...

You will be responsible for assisting in the design, review, and testing of Case Report Forms (CRFs) and electronic data capture (EDC) systems. Your role will involve supporting data entry, review, and cleaning activities under the guidance of senior data managers. Additionally, you will perform data validation and run basic edit checks to identify discrepancies. Key Responsibilities: - Assist in the design, review, and testing of Case Report Forms (CRFs) and electronic data capture (EDC) systems - Support data entry, review, and cleaning activities under the guidance of senior data managers - Perform data validation and run basic edit checks to identify discrepancies - Help create and maint...