Joju Rethnasenan
LIMERICK
Summary
As a Document Specialist & Clinical Publisher, I excel in managing and publishing regulatory documents with Veeva Vault and ensuring 99% compliance in copyright clearance. Skilled in quality checking and training, my expertise streamlines submission processes, enhancing efficiency and accuracy.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Document Specialist & Clinical Publisher
TATA Consultancy Services
Mumbai
08.2021 - 07.2024
- Managed documents in Veeva Vault throughout the life cycle, which includes providing technical expertise in preparing study-related documents for publishing, ensuring that these documents and any supporting material are compliant with the Client's technical publishing standards.
- Trainer for the Compliance Check process for 2 years, handling compliance checking of annual reports, investigator brochures, CTDs, protocols, and amendments.
- Scheduled meetings with internal and external stakeholders through emails and teleconferences to ensure the accuracy and completeness of submissions, and to resolve issues as they arise.
- Hands-on experience with Veeva Vault, Adobe Acrobat Pro, and ISI Toolbox.
- Hands-on experience with various tools (@std, Onstyle) and served as the point of contact in team submissions.
- Performing document-level publishing activities, bookmarking, hyperlinking, QC/review of documents, and rendering multiple documents to PDF preparation.
- Perform peer review and quality control review of the documents within established timelines, with adherence to applicable guidelines and processes, using appropriate checklists.
- Checking copyright clearance of literature references cited in submission documents (clinical, non-clinical, CMC) to ensure the documents are ready for regulatory submission.
- Managing non-clinical activities, like formatting and publishing internal and external reports, as per the agreed regulatory standards, to produce accurate, easily viewable documents.
- Trained new employees on the Copyright Clearance process to achieve 99% compliance on average each quarter.
- Performs internal QC for clinical and non-clinical documents that have been processed by the team members and rates QC scores.
Education
Masters - Process validation and Regulatory Affairs
Technological University of The Shannon
Limerick09-2025
Bachelors of Pharmacy - Medicine
Indira College Of Pharmacy
Pune, India05-2021
12th -
Vidya Bhavan Jr College
Maharashtra, India04-2017
10th -
Rodgers English School
Maharashtra, India06-2015
Skills
- Regulatory compliance
- Veeva Vault
- Clinical/non-clinical document
- Trainer
- ISI toolbox
- Quality checking
- Publishing
- Copyright check
- Compliance check
Extracurricular Activities
- Volunteered National Pulse Polio Vaccination Program.
- Core team member for two days Intra-Departmental Festival 'GUSTOV' at ICP College, 2018.
- Captain of KFC Football team at district level.
- Head Volunteer Inter-College Festival 'SPECTRUM' held at ICP College, 2018.
- Captain for ICP Basketball team, 2018 and also represented ICP College in Cricket and Volleyball at University level.
Certification
- Regulatory Affairs E-learning CTD modules
- Lean Six Sigma Foundations
- Drug Regulatory Affairs
Accomplishments
- On-the-spot award for extending working hours to complete a task that was urgently required by the client
- Employee of the Month (2 times)
Timeline
Document Specialist & Clinical Publisher
TATA Consultancy Services
08.2021 - 07.2024
Masters - Process validation and Regulatory Affairs
Technological University of The Shannon
Bachelors of Pharmacy - Medicine
Indira College Of Pharmacy
12th -
Vidya Bhavan Jr College
10th -
Rodgers English School
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