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

JR United Kingdom; Bristol; Remote; GBP 50,000 - 70,000; Full time

Job summary

A global clinical research organization is seeking a Senior Medical Writer to support complex clinical document preparations for submissions. This home-based role in the UK offers the opportunity to significantly impact therapy approvals and lead projects, while mentoring junior writers.

Qualifications

• Experience as a medical writer with Phase I-III protocols.
• Proven project lead experience.
• Strong stakeholder management skills.

Responsibilities

• Author high-complexity study-level documents including protocols and investigator brochures.
• Independently draft clinical evaluation plans and reports.
• Lead multiple projects and supervise 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) seeking 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 work with a renowned CRO and contribute significantly to bringing therapies to market across various therapeutic areas. You will be assigned to one sponsor, lead multiple projects, and supervise junior medical writers.

Requirements include:

• Experience as a medical writer with Phase I-III protocol and CSR medical writing
• Stakeholder management skills (internal and external)
• Project management and project lead experience

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.