CK Clinical are recruiting for an Associate Director of Medical Writing for a well-established pharmaceutical company based in Hertfordshire.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.
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.
For more information or to apply for this Associate Director of Medical Writing position, please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org, quoting job ref 48725.
It is essential that applicants hold entitlement to work in the UK.