Celegence - Senior Medical Writer - Clinical Evaluation/Technical Documentation
3 days ago
Senior Medical Writer opening in Celegence - Clinical & Regulatory Focus | Jayanagar, Bengaluru (Hybrid) Are you an experienced Senior Medical Writer specializing in clinical evaluation and technical documentation for regulatory submissions? Join our team in a challenging and rewarding hybrid role based in Jayanagar, BengaluruWe are looking for an immediate joiner with a maximum official notice period of 30 days.Required Experience & Expertise (Mandatory):- 5+ years of experience as a Medical Writer, with a strong focus on regulatory documentation.- Proven expertise in the assessment of clinical claims and benefits.- Ability to derive and interpret safety and performance parameters from clinical data.- In-depth knowledge and experience in the assessment of applicable General Safety and Performance Requirements (GSPRs).- Hands-on experience in CER Strategy Assessment, Gap Assessment, and providing robust justifications for identified gaps.- Demonstrated track record of successfully addressing Notified Body observations on Technical Files, including clinical documents.Location: Jayanagar, Bengaluru (Hybrid Mode) Notice Period: Immediate Joiner / Max 30 Days Official Notice (ref:iimjobs.com)
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