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

JR United Kingdom; Sheffield; Remote; GBP 45,000 - 65,000; Full time

Job summary

A global clinical research organization is seeking a Senior Medical Writer to support the preparation of submission and clinical documents. This role involves authoring complex documents, managing projects, and supervising junior writers. Ideal candidates will possess strong medical writing and project management experience, with a focus on regulatory submissions.

Qualifications

• Experience as a medical writer and project lead on medical writing projects.
• Phase I - III protocol and CSR medical writing experience.
• Experience with regulatory submissions.

Responsibilities

• Authoring high complexity study-level documents including protocols and investigator brochures.
• Leading on multiple projects and supervising junior medical writers.
• Preparing clinical evaluation plans and reports for global submissions.

Skills

Project management

Stakeholder management

Medical writing

Job description

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Senior Medical Writer - Global Clinical Research Organisation - Home based in UK, sheffield, south yorkshire

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Client:

Planet Pharma

Location:

sheffield, south yorkshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

1

Posted:

06.06.2025

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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) who is looking for an experienced Medical Writer to join the team and support with the preparation of submission and other complex clinical documents.

As 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 be responsible for independently authoring:

• Clinical evaluation plans and Clinical evaluations 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 play a big part in bringing key therapies to market across a variety of therapeutic areas. You will be assigned to one sponsor and you will be leading on multiple projects, as well as supervising and providing guidance to more junior medical writers.

For this position, my client is looking for someone who has experience as a medical writer and has experience working as project lead on medical writing projects.

You will also have experience with:

• Phase I - III protocol and CSR medical writing experience
• Stakeholder management - both internal and external
• Project management/project lead skills

For more information on this position or any similar opportunities, please contact Chanel Hicken on 0203 868 1011 or email your updated CV to [emailprotected] and we can arrange a time for a confidential discussion on how you can get involved in this exciting opportunity.