Of Clinical Research jobs in Kerala
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- Silmed ScientificKochi, Kerala
- Assist in clinical development strategy Review of Study reports published papers.
- We are hiring an experienced medical writer with experience in CTD medical…
- Amrita UniversityKochi, Kerala
- Applications are invited for the position of Project Staff for an ICMR-funded project under Health Science Research (HSR), Kochi Campus.
- Amrita UniversityKochi, Kerala
- Minimum 3 year of research experience in public health / maternal and child health / clinical research.
- Experience in conducting field-based research, cluster-…
- IQVIAKochi, Kerala
- Kochi, India | Full time | Hybrid | R1536965.
- Responsible for study design, edit specifications and system configurations.
- Design and update the eCRF.
- View all IQVIA jobs - Kochi, Kerala jobs - Senior Designer jobs in Kochi, Kerala
- Salary Search: Sr Clinical DB Designer salaries in Kochi, Kerala
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- Clinovex Clinical Research Solutions Pvt Ltd.Kochi, Kerala
- Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws,.
- Under supervision, perform assigned administrative…
- EXL ServiceKochi, Kerala
- Utilizes client systems to build, research and enter member information Applies clinical guidelines in determining clinical decisions Experience in patient…
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- Salary Search: 3642309-Executives salaries in Kochi, Kerala
- IQVIAKochi, Kerala
- Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced.
- Kochi, India | Full time | Hybrid | R1525505.
- View all IQVIA jobs - Kochi, Kerala jobs - Clinical Data Manager jobs in Kochi, Kerala
- Salary Search: Clinical Data Management salaries
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- IQVIAKochi, Kerala
- May perform clinical data coding.
- Kochi, India | Full time | Hybrid | R1569000.
- Provide basic and some comprehensive data management expertise to the Clinical…
- IQVIAKochi, Kerala
- May perform clinical data coding.
- Kochi, India | Full time | Hybrid | R1569000.
- Provide basic and some comprehensive data management expertise to the Clinical…
- Vaidyaratnam OushadhasalaKerala
- Minimum 3 Years of experience in Clinical Research Activities.
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- Silmed ScientificKochi, Kerala
- Advice on clinical/nonclinical Development questions/biowaiver reports.
- Ability to present research data to the target audience in a reader friendly manner.
- Lakeshore Hospital and Research CentreKochi, Kerala
- Clarify unclear or incomplete dictations with the concerned Radiologist without altering the clinical meaning of the report.
- ICON PlcThiruvananthapuram, Kerala
- Significant Clinical Data Management experience across the full clinical trial lifecycle.
- Extensive experience working with multiple EDC systems, data review…
- Amrita UniversityKochi, Kerala
- Assist with research data management and project facilitation.
- Up to 2 years (initial tenure of 11 months, extendable based on performance).
- IQVIAKochi, Kerala
- 2- 4 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 4+ yrs Req.
- Kochi, India | Full time | Hybrid | R1557356.
- View all IQVIA jobs - Kochi, Kerala jobs - Clinical Specialist jobs in Kochi, Kerala
- Salary Search: Clinical DB Validation Specialist salaries in Kochi, Kerala
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- IQVIAKochi, Kerala
- Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced.
- Kochi, India | Full time | Hybrid | R1569005.
Regulatory Associate - Medical Writing
Kochi, Kerala
Regulatory Associate - Medical Writing
Job details
Pay information not provided
Kochi, Kerala
Full job description
We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.
Responsibilities
- Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission
- Response to clinical deficiencies
- Assist with drug development strategy
- SmPC, Patient information leaflet, CCDS updates, Safety variations
- Clinical study reports, Study design and synopsis
- Assist in clinical development strategy Review of Study reports published papers
- Literature search and regulatory evaluation
- Rx to OTC evaluation
- PSURs, PADER, RMP
Requirements
- MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy
- Experience in Medical writing for regulatory submissions in Europe.
- Non-clinicaloverview / Clinical overview / PSUR / EU submission / ClinicalPharmacology / module 2.5 /Scientific Writing ICH / Regulatory Submissions / Medicine / DCP / CTD / Clinical Research / medical writer / Medical Writing / EMA labelling Module 2.4
- Scientific accuracy
- Attention to details
- Understanding of Generic, Hybrid and New drug applications
- Experience in Clinical study design and protocol
- Excellent communication skills and time management
- Specialization in Pharmacology desired.
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