Tenzin Jangchuk

Associate, PAREXEL International, Bangalore, India.

April 2021 – Present

• All responsibilities of Jr. Associate continue to apply for Associate.
• Fixing Publishing related issues (Client Comments) and validation errors.
• Clinical Study Report Publishing – Publishing CSR as per ICH E3 guideline.
• Validating submissions using different validation tools like eCTD viewer, Insight validator, EURS and Lorenz validator.
• Experienced on Ad-promo submissions for all regions.
• Hands on experience on RIMS activities using ORION RCAM and REDS tools.
• Training new joiners.

Junior Associate, PAREXEL International, India

30th April 2018 – Mar 2021

• Publishing of documents in an end-to-end process and submitting to Health authorities.
• Life Cycle Management of Drug Product (creating life cycle submissions) in different regions like US, EU, Canada, AU and GCC.
• Develop familiarity with current global regulatory submission standards.
• Post publishing activities like external hyperlinking, bookmarking, QC and validation in accordance with FDA guidelines and other health authorities.
• Creating of eCTD submissions for different regions by using Insight Publisher tool.
• External linking performed on various documents by using Smart linking tool in Insight publisher.
• Validating submissions using different validation tools like eCTD viewer, Insight validator, EURS and Lorenz e-validator.
• Hands on experience on RIMS activities which provides support in Clinical Trial Application, Data Quality Initiative and Health Registration & Management activities such as Application/PDS/package set- withdrawal, Event modify/create/delete/reopen/ split, PDS modify/create/withdrawal and package-set modify/create/withdraw in RIMS tool.
• Tools and Applications used for RIMS activities are ORION, RCAM (First-Doc) and REDS.
• Giving on job training to Junior Regulatory Associates