Senior Medical Writer - Global Clinical Research Organisation - Home based in UK

JR United Kingdom; City of Edinburgh; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global clinical research organisation is seeking a Senior Medical Writer to contribute to the preparation of complex clinical documents and submissions. This home-based role in the UK offers the chance to lead projects and supervise junior writers while ensuring quality in clinical evaluations and regulatory submissions.

Qualifications

• Experience as a medical writer with Phase I - III protocol and CSR medical writing experience.
• Strong stakeholder management skills.
• Demonstrated project management and leadership skills.

Responsibilities

• Authoring high-complexity study-level documents including protocols and clinical evaluation plans.
• Leading multiple projects and supervising junior medical writers.
• Preparing documents for global regulatory submissions.

Skills

Stakeholder management

Project management

Leadership

Job description

Senior Medical Writer - Global Clinical Research Organisation - Home based in UK

Planet Pharma is currently working with a global clinical research organisation (CRO) seeking an experienced Medical Writer to support the preparation of submission and other complex clinical documents.

As a Senior Medical Writer, you will be responsible for authoring high-complexity study-level documents including protocols, ICFs, investigator brochures, and meeting packages. You will also independently author:

• Clinical evaluation plans and reports
• Paediatric Investigational Plans (PIPs)
• Clinical summaries and overview documents in CTD/eCTD formats for global regulatory submissions

This role offers the opportunity to join a renowned CRO and contribute to bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects, and supervising junior medical writers.

The ideal candidate will have:

• Experience as a medical writer with Phase I - III protocol and CSR medical writing experience
• Stakeholder management skills, both internal and external
• Project management and leadership skills

For more information or to apply, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [emailprotected]. We can arrange a confidential discussion on this exciting opportunity.