Lavori attuali relativi a Principal Medical Writer - WorkFromHome - Syneos Health
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Principal Medical Writer
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WorkFromHome, Italia Syneos Health, Inc. A tempo pienoPrincipal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based Updated: December 3, 2025Location: Milano, MI, ItalyJob ID: -OTHLOC-3531-2DR Description Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based Syneos Health® is a leading fully integrated biopharmaceutical solutions...
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Principal Medical Writer
2 settimane fa
Principal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote Based Principal Medical Writer – Submission Docs (2.5/2.7.2/2.7.3/2.7.4) – Oncology – Remote Based at Syneos Health . Syneos Health is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Job Responsibilities Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines and standards. Manage medical writing projects, developing timelines with study/project teams and communicating with cross‑functional team members to maintain awareness of review cycles and expectations. Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and processes needed for regulatory documents. Review related documents associated with assigned projects (e.g., Protocols and Statistical Analysis Plans) as appropriate. Leverage eCTD submission experience. Responsible for writing and overseeing documents; does not mentor junior writers or manage external vendors. Additional Information: Tasks, duties, and responsibilities listed here are not exhaustive. The company may assign other tasks or responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered. The company is 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. Summary The Principal Medical Writer 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 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 timely delivery of high‑quality documents. Oversees 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. Mentors less experienced writers. Seniority level Mid‑Senior level Employment type Full‑time Job function Marketing, Public Relations, and Writing/Editing #J-18808-Ljbffr
