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

JR United Kingdom; Belfast; On-site; GBP 45,000 - 70,000; Full time

Job summary

A leading global clinical research organization seeks a Senior Medical Writer in Belfast. The role involves authoring complex clinical documents for regulatory submissions, leading multiple projects, and mentoring junior team members. Ideal candidates possess extensive medical writing experience and strong project management skills.

Qualifications

• Experience as a medical writer.
• Project lead experience on medical writing projects.
• Familiarity with Phase I - III protocol and CSR writing.

Responsibilities

• Authoring high-complexity study-level documents.
• Independently writing clinical evaluation plans and reports.
• Supervising and guiding junior medical writers.

Skills

Stakeholder management

Project management

Leadership skills

Job description

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

Planet Pharma is currently working with a global clinical research organisation (CRO) that is looking for an experienced Medical Writer to join the 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 responsible for 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, leading multiple projects, and supervising and guiding junior medical writers.

Ideal candidates will have experience as a medical writer with project lead experience on medical writing projects, including:

• Phase I - III protocol and CSR medical writing experience
• Stakeholder management, 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 about this exciting opportunity.