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

JR United Kingdom; Maidstone; Remote; GBP 50,000 - 75,000; Full time

Job summary

A global clinical research organisation is seeking a Senior Medical Writer to author high-complexity clinical documents. This role involves leading projects, supervising junior writers, and preparing vital documentation for regulatory submissions. The position offers the chance to contribute to the development of key therapies in diverse therapeutic areas.

Qualifications

• Experience as a medical writer, particularly in clinical document preparation.
• Ability to lead projects and supervise junior writers.
• Familiarity with Phase I - III protocol and CSR medical writing.

Responsibilities

• Author high-complexity study-level documents, including protocols and investigator brochures.
• Lead multiple projects while guiding junior medical writers.
• Prepare clinical evaluation plans and reports, as well as documents for global regulatory submissions.

Skills

Medical Writing

Project Management

Stakeholder Management

Leadership

Job description

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

Planet Pharma is currently working with a global clinical research organisation (CRO) that is looking for an experienced Medical Writer to join their team and 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 summary and overview documents in CTD/eCTD formats for global regulatory submissions

This is an exciting opportunity to join a globally 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 for this position include experience as a medical writer, particularly working as a project lead on medical writing projects, and experience with:

• Phase I - III protocol and CSR medical writing
• Stakeholder management (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] to arrange a confidential discussion about this exciting opportunity.