Principal Regulatory Medical Writer

Responsibilities

• Act as subject matter expert in medical writing, training writers and improving processes

• Write, edit, review and quality control CSRs and Investigator's Brochures within regulatory timelines

• Manage preparation and tracking of CSRs and IB packages for CDD-sponsored trials

• Deputise for the Medical Writing Manager and represent the group on cross-functional working groups

• Produce and maintain regulatory templates, SOPs and guidance documents

Requirements

• Science graduate (medical, biomedical, pharmaceutical or pharmacy)

• Extensive regulatory writing experience with CSRs and IBs

• Experience reviewing and quality checking other medical writers' work

• Excellent proofreading, organisational and communication skills

• Negotiation and influencing skills

Preferred Qualifications

• Experience with protocols and DSURs

• Medical or medical sciences background

• Masters or PhD

• Early phase clinical development or oncology experience

• Project management experience

Benefits

• Generous benefits package and career development opportunities

About the Company

Cancer Research UK is the world's leading cancer charity, funding research to beat cancer. The Centre for Drug Development is the world's only charity-funded drug development facility.