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

JR United Kingdom; Hemel Hempstead; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global clinical research organisation is seeking a Senior Medical Writer to work remotely. The successful candidate will be tasked with authoring complex clinical documents and leading projects while guiding junior writers. This role offers an exciting opportunity to contribute to bringing vital therapies to market.

Qualifications

• Experience as a medical writer with project lead experience.
• Proficient in phase I - III protocol and CSR medical writing.
• Strong internal and external stakeholder management skills.

Responsibilities

• Authoring high-complexity study-level documents including protocols, ICFs, and meeting packages.
• Independently author clinical evaluation plans and reports, and oversee junior writers.
• Lead multiple projects with one sponsor.

Skills

Project management

Stakeholder management

Leadership skills

Job description

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

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 significantly to bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, lead multiple projects, and supervise and guide junior medical writers.

Ideal candidates will have experience as a medical writer with project lead experience on medical writing projects, including:

• Phase I - III protocol and CSR medical writing
• Stakeholder management (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 [email protected]. We can arrange a confidential discussion on how you can get involved in this exciting opportunity.