On-siteOperations, Medical AffairsFull time
Bengaluru, Karnataka, India
OVERVIEW
Description
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Writing department. You will play a critical part in driving innovation and making an impact in the Medical affairs space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
Review and edit medical writing and clinical regulatory documents (e.g., protocols, amendments, ICFs, CSRs, CERs, CTDs, IBs, Lay Summaries, manuscripts, abstracts, posters, presentations)
Conduct quality control activities, checking accuracy of data, references, spelling, grammar, language, links, and compliance with industry guidelines.
Verify information against data sources to ensure internal and cross-document consistency.
Deliver documented QC comments or checklists and collaborate with Medical Writers and team members to resolve findings.
Liaise with internal groups (eDS, Biostatistics, Data Management, Regulatory Affairs, Clinical, QA, Medical Affairs) and sponsors to gather information and negotiate changes when required.
Support coordination of QC processes, assist other teams (Medical Advisor, Medical Monitor), contribute to training of QC Specialists, act as backup when needed, and ensure timely completion of all activities while keeping the MMW informed.
Requirements
About You
At Excelya, we value rigor, curiosity, and a collaborative mindset. We're looking for someone who brings precision, initiative, and a strong commitment to quality in clinical document review.
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