Kinesys Consulting (www.kinesysconsulting.com) provides Regulatory Strategy, Technical Writing and Regulatory Agency submissions as well as Development Strategy support to major Pharma, Biotechnology and Medical Device companies around the globe. As such, an important part of our work is in producing excellent documents which provide analyses and explanations of the science supporting the development and application of drugs, for use by our clients and for regulatory agencies (FDA, EMA, MHRA etc) assessing such products. The company therefore needs to have a team of scientists with high level writing skills. Kinesys was founded in 2007 and has a client list of over 75 companies. Kinesys has contributed to the successful development of a range of important new drug products across different therapeutic areas. We work across all drug development disciplines – CMC, Nonclinical and Clinical – and support products both in development and through life-cycle management for marketed products. The company was set up in 2007
- Educated to degree level in life sciences, medicine or pharmacy with a PhD and at least 2 years in a post-doctoral role
- Strong organisational skills, including the ability to prioritise and balance multiple priorities
- Excellent written and verbal English, and attention to detail
- Strong interpersonal skills and the ability to deal confidently with people at all levels
- Be a very good team player
- No specific knowledge of drug development or regulatory affairs is required prior to taking on the role.
This is a full-time role working simultaneously on different technical, clinical and regulatory documents. It will suit a motivated candidate able to multi-task and who enjoys a dynamic environment. This role will be located either at our Glasgow office or can be home / remote based during the pandemic. Ongoing training and development will be provided both internally at Kinesys and through professional organisations offering training and professional development facilities (e.g. European Medical Writers’ Association).
Specifically, the successful candidate will be able to:
- Achieve a consistently excellent quality of scientific / technical writing
- Demonstrate strong writing and reviewing skills
- Work with internal teams and clients to ensure projects are delivered on time
- Gain an understanding of client therapeutic areas and products
- Follow style guidelines and processes
- Work with our Regulatory Affairs, Clinical and other specialists on a range of documents and Applications related to the development and regulation of new and existing medicinal products
Please send a full CV to firstname.lastname@example.org.