Job Description

On-siteOperations, Medical AffairsFull time



Indore, Madhya Pradesh, 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 clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth



Main Responsibilities



Perform redaction and anonymisation of clinical documents (CSRs, Protocols, IBs) and ensure consistency, quality, and auditability.

Prepare, format, and submit documents for public disclosure portals (EMA, Health Canada).

Coordinate timelines and deliverables across multiple projects; ensure on-time completion.

Collaborate with cross-functional teams (Medical Writing, QA, Regulatory, Biostats, Data Management, Clinical) and interact with clients as needed.

Train, mentor, and provide backup support to RPDS team members; review and approve their redaction work.

Support project management, sponsor communication, and contribute to SOPs, processes, and financial offer preparation.

Requirements



About You



At Excelya, we value curiosity, rigor, and a collaborative mindset. We're looking for someone who is ready to grow with us and contribute to high-quality disclosure and redaction activities.

Experience:

Experience in redaction, disclosure, or regulatory roles. For senior profiles, the ability to lead, mentor, and manage complex disclosure activities is essential

Skills:

Strong understanding of EMA Policy 0070, Health Canada PRCI, and GDPR, Excellent attention to detail and strong analytical thinking, Comfortable working in fast-paced, collaborative environments, Familiarity with anonymisation tools and techniques Strong organizational and communication abilities, Leadership and mentoring capabilities for senior roles, Advanced proficiency in English

Education:

University degree in life sciences or a related field

Languages:

Professional 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.