Senior Medical Writer

PRA; United Kingdom; On-site; GBP 40,000 - 65,000; Full time

Job summary

A leading clinical research organization seeks a Senior Medical Writer to support a Top-5 pharma company. You'll produce high-quality clinical and regulatory documents and ensure they meet submission standards. Candidates should have strong writing skills, relevant experience, and an educational background in life sciences.

Qualifications

• Bachelor's degree required; Master's preferred.
• 3-5 years of Medical Writing experience with regulatory knowledge.
• Strong writing skills for converting scientific data into clear messages.

Responsibilities

• Produce clinical and regulatory documents such as Protocols and Reports.
• Analyze data to determine the best approach, applying lean writing strategies.
• Facilitate review processes to ensure documents are submission-ready.

Skills

Writing skills

Data analysis

Regulatory knowledge

Education

Bachelor's degree

Master's degree

Job description

Social network you want to login/join with:

Senior Medical Writer

Join the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Support a Top-5 pharma company by delivering best-in-class regulatory and submission documents. Enjoy stable employment with ICON and be fully embedded with our client.

Responsibilities:

1. Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. These include clinical study documents such as Protocols and Reports across Phases 1 to 3 and multiple therapeutic areas.
2. Analyze and interpret data critically to determine the best approach for each document, applying lean writing strategies.
3. Act as the primary contact for the study team regarding preparation and timelines of assigned documents.
4. Facilitate review processes, ensuring documents are submission-ready and approved, working with QC personnel and publishing specialists.

Minimum Requirements:

• Bachelor's degree required; Master's preferred.
• 3-5 years of Medical Writing or relevant pharmaceutical experience with scientific and regulatory knowledge.
• Strong writing skills to convert scientific data into clear, well-structured messages.
• Experience in independently writing clinical/regulatory documents such as CSRs and Protocols, including leading authoring, coordinating reviews, and ensuring submission readiness.