Priya Ramdoss

About Priya Ramdoss

Delivery-focused leader with 16+ years in medical devices and pharmaceuticals…

Experience

1. Senior Medical Writer

   HCLTech

   Nov 2018 — Present · Chennai, IN

   Involved in writing Clinical Evaluation Reports (CER) both EU and China.Involved in writing Periodic Risk Evaluation Reports (PRER).Good knowledge of clinical research related activities, MEDDEV, MDR guidelinesDevelopment of regulatory documents such as Risk benefit analysis (RBA’s) and Gap assessment report for devices.Experience in literature search of the relevant publications. Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documentsCollaboration with management team to provide training to Medical Writers to ensure best working practices are maintainedDevelops and manages timelines for document developmentProvide constructive feedback to investigators to improve clarity, logic, and persuasiveness of grant proposalsReliance on instructions, templates and pre-established guidelines (eg, Standard Operating Procedures) will be expected to perform the above functionsContribute to the development of frameworks, modules, templates, and general guidelines for Independent Reviewer Charter (IRCs), reviewer manuals, and imaging Case Report Forms (CRFs)

Education

• Dr. M.G.R. Medical University

  Bachelor of Pharmacy - BPharm, Pharmacy

• Tamil Nadu Doctor M.G.R. Medical University

  Bachelor's degree, Pharmacy

  2003 — 2007