Role : Medical Writer
Location : Hyderabad
Yrs of exp : 8 yrs - 14 yrs
Primary role:
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)
Team Handling and Management
Act as SME for deliverables
Conducting trainings and mentoring sessions to upskill the resources
Responsible for assessing the effort estimation for clinical projects
Support the Project/ Delivery Manager in driving the project related activities such as timelines, SOWs etc,
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RESPONSIBILITIES
Author and maintain C...