Wipro have Openings for Clinical Evaluation Report Writer
About the job
- Perform gap assessment and remediation of Medical Device Clinical Evaluation report (CER) and various post market documents
- Ability to draft and review Clinical Evaluation Plan (CEP), CER, Post market plans & report such as PMS-Plan, PMS Report, PSUR, PMCF Report
- Evaluate and draft Biological Evaluation Report (BER)
- Perform Literature search
- Establish equivalency
- Collaborates with cross functional teams such as PMS, Medical affairs, Regulatory, Risk management, R&D, etc.
- Review the work performed by peers
- Co-ordinate with Cross Functional Team for ensuring timely input and review of regulatory documents
Candidate Profile:
Graduate in Life Science
Looking for Immediate joiners
Location -Pan India
Should Have experience of 7 Yrs to 10 yrs
Should Have Experience in CER, Risk Management, PMS ,PMCF Report, BER ,clinical Study plan & Report ,PSUR
Knowledge of ISO 13485