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

JR United Kingdom; Oxford; Remote; GBP 50,000 - 70,000; Full time

Job summary

A global clinical research organization is seeking a Senior Medical Writer to author a variety of complex clinical documents from the comfort of home in the UK. This role involves leading projects, managing stakeholders, and mentoring junior writers while contributing to the regulatory submission process for key therapies.

Qualifications

• Experience as a medical writer, especially in Phase I - III protocols and CSR writing.
• Strong stakeholder management skills, both internal and external.
• Project management and leadership skills.

Responsibilities

• Authoring high-complexity study-level documents including protocols, ICFs, and investigator brochures.
• Independently author clinical evaluation plans and reports.
• Lead multiple projects and supervise junior medical writers.

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 is an exciting 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 or guiding junior medical writers.

Requirements include:

• Experience as a medical writer, especially in Phase I - III protocols and CSR writing
• Stakeholder management skills, both internal and external
• Project management and leadership skills

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