Sr. Associate, Clinical Research (Non-MD)
BengaluruFull-time3–6 yrsPosted 3 days ago
Mid-level pharma role at IN19 Alcon Laboratories (India) Pvt Ltd Company in Bengaluru. Needs 3+ years and an M.Pharm or PhD.
About the role
Sr. Associate, Clinical Research (Non-MD) at IN19 Alcon Laboratories (India) Pvt Ltd Company. Author, co-author, and support updates to CEPs, CERs, PMCF Plans and Reports, SLR protocols/reports.
What you'll do
- Author, co-author, and support updates to CEPs, CERs, PMCF Plans and Reports, SLR protocols/reports
- Apply clinical evaluation requirements, internal procedures, templates, and evidence appraisal expectations to produce clear, traceable, scientifically sound
- Ensure clinical evaluation deliverables are developed in alignment with EU MDR 2017/745 , applicable MDCG guidance , MEDDEV guidance where relevant, internal procedures
- Perform structured literature review activities, including search strategy development and execution, screening, data extraction, appraisal support, evidence synthesis
- Integrate clinical, post-market, risk management, PMS, PMCF, labeling, and state-of-the-art evidence into clinical evaluation deliverables with appropriate guidance and…
What you need
- Clinical research
- Regulatory affairs
- Documentation
- Market risk