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

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

Job summary

A global clinical research organization is seeking a Senior Medical Writer to prepare complex clinical documents. This role offers the chance to impact the market by bringing therapies to patients, requiring significant experience in medical writing and stakeholder management skills.

Qualifications

• Experience as a medical writer with Phase I - III protocol and CSR experience.
• Strong internal/external stakeholder management skills.
• Leadership and project management skills.

Responsibilities

• Author high-complexity study-level documents including protocols and ICFs.
• Lead multiple projects and guide junior medical writers.
• Independently author clinical evaluation plans and reports.

Skills

Project management

Leadership

Stakeholder management

Job description

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

Planet Pharma is currently working with a global clinical research organization (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 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, leading multiple projects, and supervising or guiding junior medical writers.

Requirements for this position include:

• Experience as a medical writer, with Phase I - III protocol and CSR medical writing experience
• Stakeholder management skills, both 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 [emailprotected]. We can arrange a confidential discussion on how you can get involved in this exciting opportunity.