The company: Kinesys Consulting (www.kinesysconsulting.com) provides Regulatory Strategy, Writing and Agency submissions support to major Pharma, Biotechnology and Medical Device companies around the globe. 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.
Job requirements: Minimum 6-7 years working in a Regulatory or Medical Writer role at a Pharma, Biotech or CRO company and a first degree or PhD in Chemistry, Pharmacy, a Biology-based discipline or Medicine. Alternatively, the role could be suitable for a Regulatory Affairs professional (Industry or Regulatory Agency) with a minimum of 6-7 years of experience and excellent writing skills, who wants to move into a writing role. The candidate will have worked on Regulatory Applications such as CTAs, Orphan Drug Applications, Scientific Advice, PIPs, EMA PRIME / FDA Breakthrough, MAA Summaries and Overviews. Experience with clinical documentation (e.g. Protocols, CSRs, IBs, etc) is also valued.
The role: The role involves working simultaneously on different technical, clinical and regulatory documents for Agency submissions, and as such will suit a motivated professional able to multi-task and who enjoys a fast-moving environment. This is a full-time, permanent role located either at our Glasgow office or, for the right candidate, the role can be home / remote based. Please apply to email@example.com with your CV and a letter of application, and for further details of the role if required.
Remuneration: Competitive salary, bonus and pension. Please note that actual salary will be commensurate with candidate experience and skill set.
Please only apply if you genuinely have the requisite skills and experience for the position.