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

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

Job summary

A global clinical research organization is seeking a Senior Medical Writer to join their team in Milton Keynes. This role involves authoring complex clinical documents and leading projects while mentoring junior writers. The position offers an exciting opportunity to contribute to critical therapies across various therapeutic areas.

Qualifications

• Experience as a medical writer and project lead.
• Knowledge of Phase I - III protocol and CSR medical writing.
• Strong project management and leadership skills.

Responsibilities

• Author high-complexity study-level documents including protocols and ICFs.
• Lead multiple projects and supervise junior medical writers.
• Prepare clinical evaluation plans and reports for regulatory submissions.

Skills

Project management

Stakeholder management

Clinical evaluation

Job description

Social network you want to login/join with:

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

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.

For this position, our client is seeking someone with experience as a medical writer and project lead on medical writing projects.

You should also have experience with:

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

For more information on this position or 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 opportunity.