Kinesys Consulting Ltd - Senior or Principal Medical/Regulatory Writer - Glasgow office or can be home / remote based
Senior or Principal Medical / Regulatory Writer
The company: 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. 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.
Role and Responsibilities: This is preferably a full-time role working simultaneously on different technical, clinical and regulatory documents, and as such will suit a motivated professional able to multi-task and who enjoys a fast-moving environment. This role will be located either at our Glasgow office or can be home / remote based.
Specifically, the successful candidate will be able to:
- Achieve a consistently excellent quality of medical / regulatory writing, acting as the lead on designated projects
- Demonstrate strong briefing, writing and reviewing skills
- Work with internal teams and clients to ensure projects are delivered on time and to budget
- Follow style guidelines and processes; ensure and advance writing standards by contributing to process improvement initiatives
- Gain an understanding of client therapeutic areas, portfolios and products
- Build relationships, and liaise effectively, with clients and external experts
Required Knowledge, Skills and Abilities:
- Minimum 6-7 years working in a Medical, Regulatory or Technical Writing role at a Pharma, Biotech or Consultancy company. Alternatively, the role would suit a Regulatory Affairs professional (Industry or Regulatory Agency) with excellent writing skills, who wants to move into a writing role
- Educated to degree level in medicine, pharmacy or life sciences, ideally with a higher degree
- Knowledge of ICH guidelines, GCP and other pharmaceutical legislation and guidance
- Experienced in Medical / Clinical / Scientific documentation across different phases of drug development, and preferably on components of Regulatory Applications such as IBs, INDs, Orphan Drug Applications, Scientific Advice, PIPs, CTD Summaries and Overviews.
- 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
Benefits: UK£45K - UK£60K for a full-time role, plus bonus and pension, commensurate with candidate experience and skill set.
Please apply to firstname.lastname@example.org with your CV and a letter of application.
Tel: +44 141 899 0081