20 Protocol Review Jobs

Role & responsibilities 1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc. 2. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required. 3. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards. ...

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry. A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ens...

The Head Clinical Operations & Clinical Strategy role in Bangalore requires a highly skilled and independent professional with expertise in clinical research. This individual will be responsible for supporting Global Research & Development activities related to clinical trials by providing excellent data interpretation, creative thinking, and persuasive communication. Working closely with the senior leadership team of R&D, the role involves determining clinical strategies for various products and markets within the global portfolio. Additionally, this position plays a key role in evaluating external partnership opportunities through due diligence assessments. Responsibilities include oversee...

Review Validation protocol, Chromatography Raw Data, Validation, Study Report, BA Report, in process report, responsible for providing response to QA. Required Candidate profile knowledge of Bioanalytical Data Review Prefer Ready to work in first and second shift MSc ,M.Pharma / B.Pharma with Bioanalytical data review experience will prefer. Perks and benefits 5 Days week, Bus Facility, Birthday Leave, 28 PL

The Clinical Data Associate II role involves providing data management support for clinical trial projects from study initiation to post-database lock, while adhering to SOPs, regulatory guidelines, and study-specific plans. Your responsibilities include supporting the Lead DM, performing data entry, quality control, developing CRF specifications, building and testing clinical databases, and maintaining data management documentation. You will also be involved in training clinical research personnel, reviewing and querying trial data, conducting medical coding, and assisting with various data-related activities such as SAE/AE reconciliation and vendor coordination. Additionally, you may contr...

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, int...

Job Descriptions : Job Title: Ass. Manager Clinical Research & IPR Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Regulatory Affairs Experience: 7 to 10 years in nutraceuticals, clinical research, and IPR. Industry: Nutraceutical / Food / Pharma Manufacturing Reports To: Head of R&D / Director Job Type: Full-Time Company Profile: - Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations uni...

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

Responsibilities: Prepare clinical study reports, protocols & newsletters Design medical affairs strategies Conduct literature reviews & ICH compliance checks Write scientific documents with CRF & KOL input Protocols, abstracts, posters, manuscripts Provident fund

As a Manager of Clinical Research at Teva Pharmaceuticals, you will play a crucial role in ensuring the proper conduct of studies related to BA/BE Studies. Your responsibilities will include complying with all applicable regulations, completing necessary forms, and adhering to the GCP, EC/Sponsor agreed protocol, Lotus SOPs, regulatory requirements, and ethical principles. Before the study starts, you will review and provide timely inputs on the protocol, obtain ethics committee approval, and ensure that all study personnel are trained and aware of their obligations. You will be overall responsible for supervising study-related activities, providing timely inputs in the protocol and Informed...

Role & responsibilities Handled Microbiology QMS Activities. Should have experience in OOS,OOT protocol review Preferred candidate profile Male Candidate Preferred

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

KEY TASKS & RESPONSIBILITIES : Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence...

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. You will follow Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study specific plans, and guidelines. Your responsibilities include supporting the Lead DM, performing data entry for paper-CRF studies when necessary, conducting quality control of data entry, developing CRF specifications, assisting in building clinical databases, and maintaining quality controlled database build documentation. You will also specify requirements fo...

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up * Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M.Pharm (Pharmacology) with 1-5 Yrs with relevant experience Interested candidates...

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries...

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical...

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, mainte...

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufa...