Job 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

The Senior Electronic Document Specialist (SeDS) takes a leadership role in coordinating and conducting quality control checks on prepared documents. With experienced and well-defined input, the SeDS ensures the accuracy, completeness, and submission readiness of documents, including cross-references, bookmarks, and navigations.

Liaising with the Quality Control Specialist for the review of the formatting of the document. Reviewing drafts and performing format submission readiness quality control (Word and PDF). Providing electronic versions of quality-checked drafts Providing additional writing, editing, and quality control services as required. Compiling and hyperlinking study reports (PDF), including cross-references for appendices. Assisting in publishing processes when required. Collaborating with the Sponsor's team for document comments and suggestions. Addition of cover pages and Table of Contents (TOC) in appendices. Reconciling the list of appendices in the report body and updating the electronic TOC. Mentors and provides guidance to eDS in document preparation, review, and submission. Assists in the coordination of eDS processes. Supports the training and development of eDS, providing guidance and support on complex issues. Liaising with internal groups such as Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, Clinical, and Quality Assurance to gather necessary information.

Requirements

About You

At Excelya, we value curiosity, precision, and a collaborative spirit. We're looking for someone eager to learn, contribute, and support high-quality document preparation within a dynamic environment.


Experience: Experience in electronic document preparation, quality control, editing, or medical writing for clinical regulatory documents (e.g., CSRs, protocols) is considered an advantage.


Skills:


Strong analytical abilities and the capacity to interpret complex data


Exceptional attention to detail and a rigorous work ethic


Intellectual curiosity, creativity, and adaptability in fast-paced settings


Excellent teamwork, interpersonal communication, and emerging leadership skills


Advanced proficiency in English (written and verbal)


Education: University graduate in life sciences or related field


Languages: Professional use of English 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.