Aizant Drug Research Solutions Pvt. Ltd Released Job Openings On 17/11/2022.Aizant Drug Research Solutions Pvt. Ltd is an integrated drug development solutions provider. Aizant was established by experienced pharmaceutical professionals with global exposure. We are a rapidly growing formulation CDMO and CRO with a diverse portfolio of capabilities partnering with health care companies specializing in new molecular entities (NMEs), generics (ANDA’s) and over the counter (OTC’s) products globally. We add exponential value to our clients R&D programs at every stage of drug development right from the discovery of the molecule to commercialization and subsequent life cycle management. We are the vital link between the pharmaceutical companies and the healthcare industry.
Aizant Drug Research Solutions Pvt. Ltd Recruiting B.Pharma,M.Pharma,B.Sc,M.Sc Candidates with 03-05 years experience for Bio Analytical & Medical Writer For Clinical Position.Complete Details for the Bio Analytical & Medical Writer For Clinical as follows.
Important Details :
- Location : Hyderabad/Secunderabad
- No of Vacancies:01
- Details of Salary:Not Disclosed by Recruiter
- Opening date for online Application:17/11/2022
- Mode of application :Online
- Time And Venue : 19th November , 9.30 AM – 4.00 PM
Aizant Drug Research Solutions Pvt Ltd, Clinical Pharmacology Unit II, Maitrivihar Commercial Complex, Block No 101 – 107 & 201-206, Ameerpet, Hyderabad, Telangana – 500016 Land Mark: Beside Passport Office, Ameerpet (or) Opposite to Bluefox Hotel
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Job Description/Skills Required
Medical Writer :
- Preparation and review of study protocols, ICF, CRF, IC/EC, Clinical /Integrated Study report and other study related documents for various regulatory as per requirement.
- Preparation of protocol synopsis
- Performing the literature search activities.
- To coordinate with sponsor regarding protocol and CSR related activites.
- Responsible for assisting and closing internal audit report.
- Archiving study documentation and correspondence.
- Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all study subjects.
- To prepare responses for audit findings.
- To ensure eTMF documents upload.
- Prepare, review and assist in updating CP SOPs.
- Dosing supervision and administration of IPs.
Bio Analytical – Operator:
1. Responsible for bioanalytical method development, method validation and routine sample analysis by using LC-MS/MS and performing as per Regulatory requirements (US FDA/ EU/ANVISA/ICH M10 etc).
2. Prepare/Check/Review of bioanalytical method validations/Study data, Reports, SOPs and Protocols conformance with GLP requirements.
3. Performing of Study sample analysis & Calibration of All the Equipments( HPLC/ S/Balance,pH meter/Pipettes etc)
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