Senior Technical Lead

HCL Tech; Dubai; On-site; AED 180,000 - 300,000; Full time

Job summary

HCL Tech in Dubai is seeking a Senior Medical Writer to prepare Clinical Evaluation Plans, CERs and related regulatory documents for Medical Devices, ensuring alignment with MEDDEV Rev 4 and MDR requirements. The role involves literature review, data interpretation, and collaborative writing with cross-functional teams.

Ideal candidates hold a Life Sciences degree, possess strong medical writing skills, and understand EU MDR guidelines.

Qualifications

• Master's or Bachelor's in Life Sciences or related field.
• Basic understanding of human anatomy and physiology; knowledge of disease pathology helpful.
• Knowledge of MDCG MEDDEV 2.7/1 Rev 4 and EU MDR.

Responsibilities

• Creation and update of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Medical Devices per MEDDEV Rev 4 and MDR requirements.
• Experience with reports such as Subject Device and State of the Art Literature Reports, PMS Plan, PMSR, PSUR, PMCF Plan and SSCP.
• Develop protocols, clinical study reports and Investigator's brochure; create Clinical Evidence Summaries and risk-benefit analyses.
• Literature searches, summarization, and analysis of data from clinical studies; contribute to consulting, editing, and statistical reports.

Skills

Medical writing

Communication skills

Scientific knowledge

Education

Life sciences degree

Job description

Job Summary

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

Key Responsibilities

• 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

Skill Requirements

• 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.

Other Requirements

Required Experience:

Senior IC