CSR Appendices Coordinator - RIMS System Exp

Updated: January 10, 2026
Location: Madrid, Spain
Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

Responsible for authoring of Clinical Study Report (CSR) Appendices and managing clinical and regulatory references.

• Defines scope of Clinical Study Reports (CSR) Appendices with the document author, coordinates and tracks activities, and performs detailed quality reviews.
• Prepares, imports, and routes documents in the regulatory information management systems (RIMS).
• Confirms completeness of documents (e.g., casebooks, literature references) by obtaining, compiling and organizing them in RIMS, maintaining strong knowledge of CSR, CSR Appendices, and CTD structure.
• Effectively communicates deliverables to stakeholders, demonstrating strong interpersonal and organizational communication skills, including conflict management.
• Manages multiple tasks within overlapping time frames, building positive and productive relationships that enable high‑quality documents to be completed on time.

Experience with RIMS systems and CSRs, strong knowledge of CTD structure, and proven ability to manage cross‑functional documentation workflows.

Over the past 5 years we have worked with 94 % of all novel FDA‑approved drugs, 95 % of EMA‑authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients. We are committed to a diverse, equitable and inclusive culture, and we support the development and progression of our employees through career development, training and a total rewards program.

We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. This statement, including compliance with the EU Equality Directive, is intended to fully comply with all obligations imposed by the legislation of each country in which we operate.