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

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

Job summary

A global clinical research organization is seeking a Senior Medical Writer to lead projects and author complex clinical documents. This home-based position in the UK offers the opportunity to contribute to critical therapies across various therapeutic areas while mentoring junior writers. Ideal candidates will have significant experience in medical writing and project management.

Qualifications

• Experience as a medical writer with project leadership.
• Expertise in Phase I - III protocols and CSR medical writing.
• Strong project management and stakeholder management skills.

Responsibilities

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

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 join their team and support the preparation of submission and other complex clinical documents.

Responsibilities include:

• Authoring high complexity study-level documents such as protocols, ICFs, investigator brochures, and meeting packages.
• Independently authoring clinical evaluation plans and reports, Paediatric Investigational Plans (PIPs), and clinical summaries in CTD/eCTD formats for regulatory submissions.

This role offers the chance to work with a renowned CRO and contribute to bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects and supervising junior medical writers.

Qualifications:

• Experience as a medical writer with project leadership on medical writing projects.
• Experience with Phase I - III protocols and CSR medical writing.
• 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 about this exciting opportunity.