Senior Medical Writer

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, II RESPONSIBILITIES Author and maintain Clinical Evaluation Plans/Reports (CEPS/...