Senior Medical Writer — Regulatory Submissions Lead

BioMarin; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company is seeking a Senior Medical Writer to manage the preparation of clinical study documents and ensure compliance with regulatory submissions. This role requires advanced medical writing experience and a strong understanding of drug development processes. The position involves collaboration with cross-functional teams and the ability to lead document preparation efforts. Ideal candidates will possess excellent communication skills and regulatory knowledge to support impactful medical writing efforts.

Qualifications

• Minimum of 6 years of experience in medical writing in the pharmaceutical industry.
• Advanced understanding of drug development processes.
• Experience writing or editing INDs, BLAs, and clinical study reports.

Responsibilities

• Draft and edit clinical study documents such as protocols and reports.
• Manage study team participation in document preparation.
• Provide peer review and editing for regulatory documents.

Skills

Medical writing

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor’s or higher degree in a scientific field

Tools

Microsoft Word

Adobe Acrobat

Document management software

Job description

A global biotechnology company is seeking a Senior Medical Writer to manage the preparation of clinical study documents and ensure compliance with regulatory submissions. This role requires advanced medical writing experience and a strong understanding of drug development processes. The position involves collaboration with cross-functional teams and the ability to lead document preparation efforts. Ideal candidates will possess excellent communication skills and regulatory knowledge to support impactful medical writing efforts.