Senior Quality Control Specialist
4 days ago
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.
Experience: Experience in quality control, editing, copyediting, or medical writing of clinical regulatory documents (such as CSRs or protocols) is considered a strong advantage.
Skills:
- Strong analytical abilities with the capacity to interpret clinical data
- Exceptional attention to detail and a solid work ethic
- Intellectual curiosity, creativity, and adaptability in fast-paced environments
- Effective teamwork, interpersonal communication, and emerging leadership skills
- Advanced English proficiency (written and verbal)
Education: University degree in life sciences or equivalent
Languages: Professional English level is mandatory, both written and verbal
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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