9 Study Protocol Jobs

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely executi...

You will be responsible for the development related activities of all Parenteral Products. This includes preparation and review of MFR for exhibit batch of Parenteral products, indenting the raw materials, RLD, Packaging Material, and other items required for product development and exhibit batches. You will also be in charge of preparing and reviewing study protocols required for exhibit batch of parenteral products, reviewing specifications like API, Excipients, In-process, finished product, Shelf life etc. of Parenteral products, and primary packaging material. Additionally, you will review BMR and BPR of Exhibit batch, support Regulatory affairs department for ANDA submission and respond...

As a candidate for this position, your role will involve working in accordance with cGMP guidelines and ensuring compliance with current guidelines and SOPs. You will be responsible for aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Your duties will include performing instrument calibration and maintaining instruments/equipment as per SOPs, as well as following safety precautions outlined in laboratory procedures. Key Responsibilities: - Conduct method development studies for Drug Substance, Drug Product & In-process Materials related to Peptides. - Perform method validation studies for Drug Substance, Drug Produc...

Position: Medical Writer I / Senior Medical Writer Experience Required: 6 to 8 years (CRO preferred / Pharma) Qualification: M. Pharm (Pharmacology) / Pharm D Location: Remote (Work from Home) Job Type: Full-time, Remote Key Responsibilities (Must-Have Skills) - Independently prepare, review, and finalize Protocols - Concept Sheets - Investigators Brochure (IB) - Informed Consent Forms (ICF) - Case Report Forms (CRF) - Ensure compliance with regulatory requirements Nice-to-Have Skills - Module 2 (CTD) Documents - Regulatory briefing documents - Manuscripts and publications - Scientific presentations / posters - Experience with global teams Role & responsibilities Act as the primary point of ...

QA In-Charge (Late Phase) The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Responsibilities 1. Review and maintain QMS documents like SOPs, Change control, deviations, events. 2. Responsible for conducting Internal/External audits (i.e., Investigator site audits) for Clinical Trial Projects to ensure compliance with SOPs, Protocol, ICH GCP, quality system and applicable regulatory requirements. 3. Responsible for planning, conducting, and reporting of system audit of clinical trial, clinical data ma...

Job Summary The Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the clinical team. The Medical Monitor acts as the key medical contact for study teams, sites, sponsors, and regulatory authorities. Key Responsibilities Provide continuous medical and scientific oversight for late-phase clinical studies. Ensure subject safety through regular review of adverse events, SAEs, and safety signals. Conduct medical ...

As a candidate for this position, you will be responsible for working in compliance with cGMP guidelines and SOPs. Your primary focus will be aligning with the organization's goals and carrying out any additional responsibilities assigned by your reporting authority. Key Responsibilities: - Perform instrument calibration and maintain instruments/equipment according to SOPs - Follow safety precautions outlined in laboratory procedures - Conduct method development studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Perform method validation studies for Drug Substance, Drug Product & In-process Materials related to Peptides - Analyze routine samples and stabili...

Job Summary The Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the clinical team. The Medical Monitor acts as the key medical contact for study teams, sites, sponsors, and regulatory authorities. Key Responsibilities Provide continuous medical and scientific oversight for late-phase clinical studies. Ensure subject safety through regular review of adverse events, SAEs, and safety signals. Conduct medical ...

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely executi...