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

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

Job summary

A global clinical research organisation seeks a Senior Medical Writer to author complex clinical documents. This role involves leading projects, supervising junior writers, and requires experience in medical writing for regulatory submissions. Join a renowned CRO and contribute to bringing therapies to market.

Qualifications

• Experience in medical writing for Phase I - III protocols and CSRs required.
• Strong stakeholder management skills.
• Proven project management and leadership abilities.

Responsibilities

• Author high-complexity study-level documents including protocols and investigator brochures.
• Independently author clinical evaluation plans and reports.
• Supervise junior medical writers and lead multiple projects.

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) seeking an experienced Medical Writer to 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 join a renowned CRO and contribute significantly to bringing therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects and supervising junior medical writers.

Requirements include:

• Experience in medical writing for Phase I - III protocols and CSRs
• Stakeholder management skills, both internal and external
• Project management and leadership skills

For more information, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [emailprotected] for a confidential discussion about this opportunity.