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

JR United Kingdom; Cheltenham; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global clinical research organisation is seeking a Senior Medical Writer to support submission preparations and author complex clinical documents. The position is home-based in Cheltenham, offering the chance to contribute to key therapies across various therapeutic areas, leading projects and mentoring junior writers.

Qualifications

• Experience as a medical writer, particularly in Phase I-III protocols.
• Strong project leadership skills in medical writing projects.
• Familiarity with clinical evaluation plans and regulatory submission formats.

Responsibilities

• Authorship of high-complexity study documents including protocols and meeting packages.
• Supervising junior medical writers and leading multiple projects.

Skills

Project management

Leadership

Stakeholder management

Job description

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

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

As a Senior Medical Writer, you will author high-complexity study 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, lead multiple projects, and supervise junior medical writers.

Requirements include experience as a medical writer, project leadership in medical writing projects, and familiarity with:

• Phase I - III protocol and CSR medical writing
• Stakeholder management (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.