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