Senior Technical Lead

Medical writers should possess scientific and medical knowledge along with excellent communication and passionate writing skills. Medical writers work in teams in conjunction with other professionals to deliver high quality and accurate information to clients.

Job Location: Dubai

Prior Experience: relevant CER and systematic literature review experience preferably with experience in Orthopedics

• Responsible for creation and update of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) of Medical Devices as per MEDDEV Rev 4 and MDR regulations.
• Should have experience in handling reports such as Subject Device and State of the Art Literature Reports Post Market Surveillance (PMS Plan) Post Market Surveillance Report (PMSR) Periodic Safety Update Report (PSUR) Post-market clinical follow-up (PMCF) Plan and Post-market clinical follow-up Report and Summary of safety and clinical performance (SSCP)
• Responsible to work on Protocol development Clinical study reports and Investigators brochure Clinical Evidence Summaries Risk-benefit analysis reports.
• To perform tasks including literature search summarizing and analyzing data from clinical studies consulting editing statistical and clinical reports

- Any Masters or Bachelors degree in Life Sciences B. Pharm M. Pharm PharmD Medical Microbiology Biotechnology Pharmaceutical Engineering.

- Basic understanding of human anatomy and physiology is preferable. Knowledge of disease pathology and their treatment is an advantage.
- Good understanding of MDCG MEDDEV 2.7/1 Rev 4 and EU MDR

- Good grasp over medical writing techniques is eminent.