Are you a brilliant and critical medical writer? Do you have the analytical skills to communicate scientific and medical information in a clear and concise manner? Are you proficient in interpreting and presenting clinical data and other complex information?
A talented medical writer with a specific focus on oncology drug development. Someone who perfectly understands scientific and clinical data and can translate this to concise yet compelling information useful for both the client and authorities.
- Lead the drafting of medical documentation, including but not limited to, clinical trial synopsis, clinical trial protocols and clinical study reports.
- Coordinate the production and distribution (reviewing process) of draft and final documents to project team and sponsor. Ensure that all work is complete and of high quality prior to distribution, internally and externally to the sponsor.
- Perform literature searches/reviews as necessary and in order to obtain background information and training for development of documents.
- Review statistical analysis plans and statistical outputs to assist in determining appropriateness of content/format for medical writing.
- Initiate and manage the development of templates, forms and general guidelines for medical documentation and workflow procedures.
- A PhD in a scientific or medical discipline with a high interest in oncology drug development
- Minimum of 2 years’ experience and a proven record in medical writing in oncology, including:
- Writing clinical trial protocols and clinical study reports
- Reviewing statistical analysis plans and outputs
- Drafting regulatory dossier documentation and scientific papers
- Ability to communicate scientific or medical information in a clear and concise manner.
- Ability to interpret and present clinical data and other complex information.
- Have knowledge of
- English language and grammar
- Relevant standards and regulations
- Good Clinical Practice (GCP)
- Ability to work independently
- Client-oriented and proactive
- Ability to work in a fast-paced environment and meet frequent deadlines.
ou will be part of SMS-oncology’s Consultancy team that provides services throughout the whole drug R&D process and spans the preclinical and clinical arenas. Read more about the Consultancy department.
SMS-oncology is one of the few CROs in the world solely dedicated to oncology. With our unique business model of integrating oncology drug development affairs and clinical operations, we cover the whole value chain from trial design to the setup, management and completion of phase I to IV oncology trials. We specialize in early phase, pediatric and immuno-oncology trials.
Our goal is to be the leading oncology CRO. We believe that oncology trials require oncology experts. Our clients can rely on our expertise and our proactive, responsive and pragmatic approach. Our mission is to excel in oncology trials for the benefit of our clients and cancer patients worldwide.
SMS-oncology nurtures a high performance culture, provides continuous training, offer unique opportunities to learn, and stimulates personal and organizational development. Our high performance culture impacts our retention rate positively, as represented by our industry leading rate of ~95%.
What can SMS-oncology offer you?
- Be part of one of the few oncology CROs in the world to contribute to the development of innovative cancer therapies
- Thrive in a fast growing, dynamic and inspiring working environment
- Flourish in a high-performance culture that stimulates personal development and values happiness, autonomy and proactivity
- Get exciting opportunities to further develop yourself in more senior positions and/or more responsibilities
Do you want to know more information regarding this vacancy, please contact our recruitment team via +31 (0)20 4350580.