Associate Director of Medical Writing
A leading pharmaceutical client is searching for an Associate Director of Medical Writing to join their team in the UK. The company specialises in various therapy areas including oncology, neurology, and gastroenterology, and employs several thousand across the globe.
- Preparation of clinical and regulatory documents for the Oncology therapeutic area.
- Main duties/responsibilities
- Responsibilities will include but not be limited to:
- As a compound lead, independently prepare, and at times direct, the writing of protocols and amendments.
- Independently prepare, and at times direct, the writing and all sections of the CSRs.
- Lead the preparation of clinical sections of submission documents, such as Module 2 summaries, briefing books, Global Investigator Brochures (GIB), and annual regulatory reports.
- Liaise with other functional areas and groups in the development of document standards and structure.
- Implement document quality controls, standards, and best practices.
Skills and Requirements:
- Educated to Bachelor's degree in life sciences; RN, Master's degree in life sciences, PharmD, or PhD preferred.
- Demonstrated experience writing clinical and regulatory documents in the pharma industry.
- Experience in writing clinical study protocols, CSR's, and Module 2 clinical summaries.
- Prior experience in oncology therapeutic area is desired.
- Proficiency using an electronic document management system.
- Strong analytical ability to interpret clinical data.
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Terence Au at +44 203 861 8605 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.