23 July, 2022
Clinexel Hiring for Medical and Safety Writers
We are hiring for the following positions:
1. Executive/ Sr Executive in the Quality Assurance & Training department
To facilitate various activities of the department including SOP management, NC-CAPA documentation, conduct vendor audits, participate in client audits, management of Training calendar, training files and training documentation.
· Desirable Qualification- B.Pharm/ M. Pharm/ M.Sc
· With 3-5 years of industry experience in quality assurance
· Good knowledge of GCP and GVP
· Well versed with regulations
2. Manager in Clinical Data Management & Biostatistics department
3 to 5 years of experience in clinical research industry, experience in study set-up phase and data analysis phase, including eCRF design, subject diary inputs, edit checks, UAT, external data load, data validation activities during conduct and database lock, data review, query management, external data load review, query management, SAE reconciliation, creating data listings and reports. Candidates with good knowledge of GCP /GDMP and ability to use SQL and other programming and query languages will be preferred
3. Medical and Safety Writer
3- 5 years of industry experience in medical and/ or safety writing, scientific background and preparation of essential documents for clinical trials. Scientific background with writing experience in multiple therapeutic areas. Demonstrated understanding of clinical research, pharmacovigilance, the drug development process, guidelines and regulations.
These are office-based positions, working from CLINEXEL office on Palm Beach Road, Sanpada, Navi Mumbai.
If you are interested in being part of a high performing team working on high quality projects, please share your resume at email@example.com