Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain
Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
technical and therapeutic area training; The Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally.
Provides strategic direction to cross‑functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators’ Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data‑driven clinical messages in accordance with program goals and regulatory requirements.




Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.
Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
Has a broad understanding of clinical research processes and global regulatory document standards.
Reports to a Director of Medical Writing or above.
Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other integral guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross‑functional team members to maintain awareness of review cycles and expectations.
Participate in

📌 Medical Writer Junior (Madrid)
🏢 Syneos Health
📍 Madrid