Associate Director, Medical Writing
CK Clinical are recruiting for an Associate Director of Medical Writing for a well-established pharmaceutical company based in Hatfield, UK.
The Associate Director of Medical Writing Role:
- Preparation of clinical and regulatory documents for the Oncology therapeutic area.
- As a compound lead, independently prepares, and at times directs the writing of protocols and amendments; independently prepares, and at times directs the writing, 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.
Your Background: Qualifications and Education required:
- 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.
- Excellent writing skills.
- Meticulous attention to detail.
- 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.
Skills and Aptitude required:
- Strong interpersonal skills with an ability to communicate across different levels.
- Diplomacy and rationale in difficult situations.
- Ability to handle many tasks and setting shifting and competing priorities.
- Ability to direct the work of others and acts as a coach and mentor to staff members.
- Excellent project management skills related to medical writing documents.
- Creative and analytical in approach.
- Attention to detail and accuracy.
- Excellent spoken and written English.
- Maintain confidentiality, particularly related to employee personal information.
Apply: For more information or to apply for this Associate Director of Medical Writing position, please contact Rob Angrave on 01438 870022 or email firstname.lastname@example.org, quoting job ref 46796.
It is essential that applicants hold entitlement to work in the UK.