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

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

Job summary

A leading global clinical research organisation is seeking a Senior Medical Writer to join their team. This role involves authoring high-complexity clinical documents and managing projects and stakeholders. You will lead multiple projects while guiding junior writers, contributing significantly to bringing key therapies to market.

Qualifications

• Experience as a medical writer, particularly with Phase I - III protocols and CSR.
• Strong stakeholder management skills.
• Project management and lead experience.

Responsibilities

• Author high-complexity study-level documents including protocols, ICFs, and investigator brochures.
• Independently write clinical evaluation plans and reports for global submissions.
• Supervise and guide junior medical writers.

Skills

Stakeholder management

Project management

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 be independently authoring:

• Clinical evaluation plans and clinical evaluation 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 significant role in bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor and will lead multiple projects, as well as supervise and guide junior medical writers.

Requirements include:

• Experience as a medical writer, particularly with Phase I - III protocols and CSR medical writing
• Stakeholder management skills, both internal and external
• Project management and project lead experience

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 about this exciting opportunity.