Summary
HCLTech is seeking a Medical Writer for a role based in Dubai. The role involves preparing and updating clinical evaluation documents for medical devices, including CERs, CEPs, PMS and PMCF reports, and safety and clinical performance summaries. Duties also include developing protocols and clinical study reports, conducting literature searches, and analyzing clinical data. Applicants should have a degree in Life Sciences and knowledge of medical writing, MDCG, MEDDEV 2.7/1 Rev 4 and EU MDR; experience with CERs and systematic literature reviews is required, with orthopedics experience preferred.
The posting
As published on hcltech.com. Pulled from the employer's site and shown as they wrote it.
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 Investigator’s 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 Master's or Bachelor's 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.