Anupama B Email and Phone Number

Regulatory Experienceo Clinical trial reportso Clinical overviewso Safety narrativesPublication experienceo Review articles, RCT and observational studieso Abstractso Posterso Green template summariesExpertise in Medical Deviceso Proficient in Clinical Evaluation Reports – reviewing, risk analysis, post-market surveillance data analysis, submissions and client & notified body engagement managemento Successful submission to various notified bodies such as BSI, SGS, TUV, TGA and China FDA for a variety of devices such as Class III, Class IIa and softwareso Developed responses to queries raised by notified bodieso Developed CER Template in accordance to MEDDEV 2.7/1 rev 4 guidelines for clientso Develop clinical appraisal plan and strategies to ensure scientific rigor in the analysis, execution o Experience in other deliverable on medical devices include manuscripts, compendium and dossier development, clinical study reports, educational materials.Non-promotion deliverables: o Slide decks, e-modules and articulates for MSLso Newsletters for MSLso Standard medical response letters o Content support for advisory board meetings for leading pharma companiesPromotional deliverables o E-moduleso Slide deckso Articulates, storylineo Patient Caseso Annotated reprintso Websites, E-blasts Job Profile Review and quality check of content generated by team members Direct interaction with clients on calls Developing proposals, effort estimates, and content outlines Ensuring all projects and deliverables meet CMMI level 3 Working with client servicing managers and project managers to ensure timelines are met and the quality of the deliverables are maintained Coordinating with various teams such as editorial, creative, tech to ensure smooth running of projects Operational knowledge of project management tools such as salesforce, clarizen