FSP Principal Medical Writer (Regulatory) - Client-Dedicated

Job Title: FSP Principal Medical Writer (Regulatory) - Client-Dedicated

We are excited to expand our Medical Writing FSP Team in Europe This would be a remote role. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Neurology, Immunology, Oncology or Vaccines would be valuable but not essential. As a Principal Medical Writer you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, you will review documents for the team and provide training and guidance to junior team members. As a subject matter expert you will provide advice on document development strategy, regulations, and industry best practices. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Job Location

Remote, United Kingdom

Job Location Type

Remote

Job Contract Type: Full time

Job Seniority Level:

Environmental Conditions: Office

Work Schedule

Standard (Mon-Fri)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Essential Functions:

• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
• May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods, and techniques for achieving optimal results, including various client- specific processes, and leads process improvement initiatives. May also develop, review, and manage performance metrics for assigned projects.
• Represents the department at project launch meetings, review meetings, and project team meetings.