Senior Medical Writer
posted by: spj_bot
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 affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
- Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
- Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
- Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
- Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
- Manage timelines, planning, and document reviews efficiently to support submission milestones.
Requirements
About You