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

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

Job summary

A leading global clinical research organization is seeking a Senior Medical Writer to author complex clinical documents and lead projects. This home-based position will involve working closely with sponsors and mentoring junior staff. Applicants should possess extensive experience in medical writing and project leadership skills in a dynamic environment.

Qualifications

• Experience in medical writing for Phase I - III studies.
• Proven project leadership in medical writing projects.
• Ability to manage both internal and external stakeholders.

Responsibilities

• Author high-complexity study-level documents including protocols and investigator brochures.
• Independently guide junior medical writers and lead multiple projects.
• Prepare clinical evaluation plans and reports for global submissions.

Skills

Project management

Stakeholder management

Medical writing

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 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 position offers 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, leading multiple projects and supervising or guiding junior medical writers.

Ideal candidates will have experience as a medical writer, with project leadership experience in medical writing projects.

Required experience includes:

• Phase I - III protocol and CSR medical writing
• Stakeholder management (internal and external)
• Project management and leadership skills

For more information or to discuss similar opportunities, 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 role.