We are looking to expand our highly skilled, science-driven writing team with two new Regulatory & Scientific Writers, one being at entry level and the second at a more senior level. The company considers internal and external training and development of its staff to be of the utmost importance, and as such will provide training and development to selected candidates.
The Company
Kinesys Consulting (www.kinesysconsulting.com) is a high quality, boutique consultancy providing Regulatory Affairs, Scientific / Regulatory Writing and Medical Device support to major Pharma, Biotechnology and Medical Device companies around the globe. As such, we produce excellent quality documents with analyses and summaries of the science supporting the development and application of novel drugs for our clients and for regulatory agencies (FDA, EMA, MHRA etc). This includes applications for marketing authorisation, scientific advice, orphan drug designation, paediatric investigational plans, and clinical trial applications, as well as protocols, CSRs, IBs, manuscripts and patient narratives.
Kinesys was founded in 2007. The company’s head office is in Glasgow, with a subsidiary office in Amsterdam. Kinesys has a client list of over 100 companies in EU, USA, UK and other global regions. Kinesys has contributed to the successful development of a wide range of important new drug products (NCEs, biologics, ATMPs, devices) across different therapeutic areas. We work across all drug development disciplines – CMC, Nonclinical and Clinical.
Job Requirements
Working in a growing company, the contribution of all staff members is always significant, not only to Kinesys, but to our clients and their projects. We are therefore seeking candidates who enjoy seeing the difference that their work makes on a daily basis. We hire people that add to our culture, then invest in developing their skills and abilities. If your current experience does not exactly match the requirements below, you may still be a good fit for our company. We therefore encourage you to apply for the position and explain in your cover letter why you think you are a good candidate for this role or others.
Requirements
Educated to degree level in life sciences, human or veterinary medicine, or pharmacy, plus a PhD (not necessary for medical degree or veterinary candidates). For the more senior role, candidates should have relevant experience in the pharma / biotech / medical writing industries, or at a regulatory agency. Entry level candidates require at least 2 years in a post-doctoral role.
Strong organisational skills, including the ability to prioritise and balance multiple tasks.
Enjoy working in cross-functional teams.
Experience of writing and reviewing technical reports, manuscripts or similar relevant documents.
Excellent written and verbal English, and excellent attention to detail.
Strong interpersonal skills, team player and the ability to deal confidently with people at all levels.
The Roles
The roles involve working simultaneously on different technical, clinical and regulatory documents. They will suit motivated candidates who are able to multi-task and enjoy a collaborative, dynamic environment. The roles will be located at our Glasgow office but with hybrid home working if preferred. For the more experienced role, the position may be fully remote, at discretion of management.
Specifically, the successful candidates will:
Achieve a consistently excellent quality of scientific / regulatory writing across a range of documents and regulatory applications, typically working closely in small teams.
Work with our Regulatory Affairs strategists, as well as Nonclinical, Clinical and other specialists, on documentation related to the development and regulation of novel medicinal products.
Work collaboratively within internal and client project teams to ensure projects are delivered on time and to expected high quality standards.
Gain an understanding of client therapeutic areas and products as well as international regulatory requirements.
Follow internal and client style guidelines and procedures.
Benefits
The company offers a very competitive compensation package, including salary, bonus and pension, commensurate with candidate experience and skill set. Ongoing training and development will be provided both internally at Kinesys and through professional organisations (e.g., European Medical Writers’ Association, American Medical Writers’ Association). Career progression is also encouraged. Kinesys has a flexible approach to working arrangements and we believe that our success is based on each team member’s contribution. That is why we promote a positive work / life balance, and a pleasant and collaborative working environment.
How to Apply: https://www.pharmiweb.jobs/job/1758430/2-x-regulatory-and-scientific-writers/?LinkSource=PromotedJob