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

JR United Kingdom; Stockport; Remote; GBP 45,000 - 70,000; Full time

Job summary

A global clinical research organization is seeking a Senior Medical Writer to join their team in Stockport. This home-based role involves authoring complex clinical documents and leading multiple projects while supervising junior writers, contributing to essential therapy advancements.

Qualifications

• Experience as a medical writer.
• Leading medical writing projects.
• Experience with Phase I-III protocols and CSR documents.

Responsibilities

• Author high-complexity study-level documents including protocols and ICFs.
• Independently author clinical evaluation plans and reports.
• Supervise junior medical writers.

Skills

Stakeholder management

Project leadership

Job description

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

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 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.

The ideal candidate will have experience as a medical writer, leading medical writing projects, and working with Phase I-III protocols and CSR documents. Stakeholder management and project leadership skills are also essential.

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