– 23/Aug/2012, 12:00:00 AM
About the Job
Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Our groundbreaking work into the prevention, diagnosis and treatment of cancer has helped ensure survival rates doubled in the last 40 years.
Cancer Research UK supports over 500 research group leaders throughout the UK, and works with many of the UK’s top scientists and clinicians in the field of oncology.
The Drug Development Office (DDO) is a dedicated and experienced department that provides independent sponsorship of Phase I/II oncology clinical trials throughout the UK. The DDO has a diverse portfolio of cutting-edge, high quality agents and works to progress anti-cancer agents that may otherwise never be developed.
The DDO is now looking to recruit a Senior Medical Writer to sit within the Regulatory function. This office-based role will lead the development of the medical writing team within the DDO, providing broad medical writing expertise for the production of Clinical Study Reports, Investigator Brochures and other clinical/scientific reports.
The ideal candidate would be an experienced medical writer who is keen to develop a specialist medical writing function in a niche drug development environment.
We’re looking for an enthusiastic and proactive individual…
• To manage the medical writing function in DDO, to achieve best practice and deliver high quality documents.
• To identify opportunities to establish and develop the medical writing team as a specialist, expert function in DDO.
• To provide specialist medical writing skills to ensure timely production of Clinical Study Reports (CSRs) and Investigator Brochures (IBs) within applicable regulatory timeframes.
• To manage the preparation of CSRs by building consensus with the project teams on CSR requirements.
• To maintain oversight of all IBs in use in DDO sponsored trials.
• To manage the preparation and updating of IB packages in use in DDO-sponsored trials.
• To lead the continuous review and im
provement of document writing processes in DDO.
• To provide medical writing training/mentoring to other team members and key groups in DDO.
Beating cancer is a real challenge. Here at Cancer Research UK we have 3,500 talented people who are passionate about achieving this vision and thrive in our complex, diverse and dynamic environment. Now we need a Senior Medical Writer to bring specialist writing expertise and vision to develop and manage the medical writing function in DDO ensuring the success of our early phase clinical trials.
• Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy).
• Extensive experience of writing regulatory reports and clinical/scientific documents
• Good knowledge of regulatory requirements for clinical trial documents
• Demonstrated ability to produce high quality, scientifically/medically accurate reports
• Excellent proofreading skills and attention to detail
• Ability to review and QC documents to ensure they meet the project brief/specification and are scientifically and technically accurate
• Strong interpersonal skills to foster good relationships both internally and externally
• Line management experience
• Medical/Medical Sciences background or experience
• Higher degree (Masters or PhD)
• Experience in early phase clinical development
• Oncology experience
• Project management experience
About Cancer Research UK
Cancer Research UK is the world’s largest cancer charity dedicated to beating cancer through research. With a total of over £332 million spent on research during the 2010/11 financial year, funding the work of more than 4,000 researchers, doctors and nurses throughout the UK, our groundbreaking work into the prevention, diagnosis and treatment of cancer has saved millions of lives’. With over 3,500 staff, we are a large, complex, dynamic and diverse charity.
How to Apply
All applications should be made via the Cancer Research UK careers website, where you will need to create a profile before you can submit an application.
Our online application process also involves attaching your CV and Covering letter which should outline your interest in applying for the role and explain how you meet the set criteria.
You can apply for a job by clicking on the Apply Online link at the bottom of each job posting.
A full role profile is available here (pdf)
Location: Angel – Head Office, Islington
Hours: Full Time
Contract type: Permanent
Closing Date: 22-Aug-12