Lead Medical Writer – Regulatory Submissions

Syneos Health, Inc.; Greater London; On-site; GBP 60,000 - 109,000; Full time

Job summary

A biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the medical writing process. This role involves managing and completing a variety of important documents related to clinical studies, ensuring clarity, accuracy, and adherence to regulatory standards. The ideal candidate will have 3-5 years of relevant experience, a strong understanding of FDA and ICH regulations, and excellent communication and project management skills. A supportive environment focusing on career development is offered.

Benefits

Health benefits including Medical, Dental, and Vision

401(k) company match

Flexible paid time off (PTO)

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience writing relevant document types required.
• Strong understanding of FDA and ICH regulations.

Responsibilities

• Lead completion of medical writing deliverables clearly and accurately.
• Manage writing activities associated with studies with minimal supervision.
• Complete various documents, including clinical study protocols, reports, and manuscripts.

Skills

Presentation skills

Proofreading skills

Project management skills

Interpersonal skills

Strong proficiency in MS Office

Understanding of medical terminology

Education

Bachelor's degree in a relevant discipline

Graduate degree preferred

Job description

A biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the medical writing process. This role involves managing and completing a variety of important documents related to clinical studies, ensuring clarity, accuracy, and adherence to regulatory standards. The ideal candidate will have 3-5 years of relevant experience, a strong understanding of FDA and ICH regulations, and excellent communication and project management skills. A supportive environment focusing on career development is offered.