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

JR United Kingdom; Stoke-on-Trent; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading global clinical research organization (CRO) is seeking a Senior Medical Writer to prepare submission and complex clinical documents. This home-based role involves authoring critical documents for regulatory submissions and guiding junior writers, offering an exciting opportunity to contribute to therapies across various therapeutic areas.

Qualifications

• Experience as a medical writer with Phase I-III protocol and CSR medical writing.

Responsibilities

• Author high-complexity study-level documents including protocols and investigator brochures.
• Independently author clinical evaluation plans and reports.

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) 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 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 include:

• Experience as a medical writer with Phase I-III protocol and CSR medical writing
• 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 how you can get involved in this exciting opportunity.