Rupam

About Rupam

I am a medical writing professional with over 8 years of experience in Clinical Research. I am currently a Senior Medical Writer at ICON plc. My roles and responsibilities include writing and reviewing imaging documents for oncology studies for different modalities and anatomy: Site Imaging Manual, Independent Review Charter, and Independent Review Training Manual) based on RECIST v1.1 criteria for assessing lesions and tumors. Authoring and reviewing of Clinical trial disclosure activities-Results posting. Continuous learning on Clinical Trial Information System and Modernization of CT.Gov (PRS). Trained on redaction using tool and system. Prior to ICON, I was a Senior Medical Writer at Syneos Health working on clinical trial disclosure activities which included registration and results posting (CTG and EudraCT database) and redaction of documents (CTD Modules 1 to 5, Policy 007 and Health Canada). I am trained on Patient Lay summary (PLS). I am working towards becoming a subject matter expert in clinical trial transparency and disclosure. I am actively involved in project management activities and development of project related guidance and process guidance/documents and related documents for multiple Clients. I had worked as a Medical Writer at PAREXEL for over two years. Apart from writing experience, I was actively involved in project initiation, planning, coordination, maintenance, and execution. I have also mentored writers over new or ongoing projects. Prior to PAREXEL, I had worked for over 2 years as Clinical Data Reporting Scientist at Novartis Vaccines/GSK Vaccines (Insourced by Clintec International Pvt. Ltd). I also have 10 months of experience in bio-availability/bio-equivalence study at Norwich Clinical Services Pvt. Ltd (CRO). I did my M. Pharm project on BA/BE study of anti-leprotic drugs and on Healthcare management in India. I am passionate about learning and experiencing more about medical writing and clinical trials. I would like to work in an organization which provides me roles and responsibilities relevant to my qualification and experience so that I could explore more in the areas of my interest within medical writing and disclosure.

Experience

1. Senior Medical Writer

   ICON plc

   Jul 2022 — Present · Bengaluru, IN

Education

• Devi Ahilya Vishwavidyalaya

  Bachelor of Pharmacy - BPharm, Pharmacy

  2007 — 2011

• Birla Institute of Technology, Mesra

  Master in Pharmacy, Clinical Research

  2012 — 2014

• Kairali School

  High school

  1992 — 2006