Celegence - Senior Medical Writer - Clinical Evaluation / Technical Documentation

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, Bengaluru!

We 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)