Senior Medical Writer: Regulatory Submissions Leader

BIOMARIN; London; On-site; GBP 50,000 - GBP 75,000; Full time

Job summary

A leading biotechnology company in London is seeking a Senior Medical Writer to draft and manage clinical study documents. This role involves collaboration with cross-functional teams to ensure the production of high-quality regulatory submissions and reports. The ideal candidate will have a relevant bachelor's degree, up to 10 years of experience in medical writing, and strong project management skills. The position offers a chance to contribute to transformative medicines for patients with genetic conditions.

Qualifications

• 3-10 years of medical writing experience in the pharmaceutical industry.
• Experience with INDs, BLAs, and regulatory documents preferred.
• Advanced understanding of the drug development process.

Responsibilities

• Draft and edit clinical study documents and reports.
• Manage document preparation and cross-functional team participation.
• Ensure adherence to regulatory requirements and best practices.

Skills

Advanced medical writing skills

Project management skills

Interpersonal skills

Regulatory knowledge

Technical writing

Education

Bachelor’s degree or higher

Tools

Microsoft Word

Excel

Adobe Acrobat

MS Project

Job description

A leading biotechnology company in London is seeking a Senior Medical Writer to draft and manage clinical study documents. This role involves collaboration with cross-functional teams to ensure the production of high-quality regulatory submissions and reports. The ideal candidate will have a relevant bachelor's degree, up to 10 years of experience in medical writing, and strong project management skills. The position offers a chance to contribute to transformative medicines for patients with genetic conditions.