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Kinesys Consulting provides Strategic Development, Regulatory Affairs and Technical Writing support and services to a highly varied portfolio of clients within UK, Europe and USA, as well as in emerging and other markets. Since 2007, we have been known as a high-quality service provider whose senior consultants have a wealth of experience and expertise across most biopharmaceutical product classes, therapeutic areas and regulatory applications. We regularly represent clients at EMA, EU NCAs, and US FDA for different types of projects and Applications, including at key regulatory meetings such as Oral Explanations and Appeals. The company benefits from a top class Advisory Board whose members are available to help resolve our clients’ regulatory, clinical, nonclinical and CMC challenges. Kinesys’ Head Office is based in Glasgow, UK, while some senior consultants are located in other parts of EU and USA. Kinesys provides consultancy and contracting services to many major pharmaceutical companies and to both large and developing Biotechnology firms. We also provide Non-Executive Director and Scientific Advisory Board members.
Permanent position, 4-5 days per week
Entry level and experienced writers (2 vacancies)
Hybrid working, potentially fully remote for experienced candidates
UK / EU nationals only
Working in a small but 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.
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:
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.
Please send a full CV to firstname.lastname@example.org.
Profile of person for the role
Responsibilities of the Role
You will also have:
More about Kinesys Consulting Ltd…
Kinesys was set up in 2007. The company is registered in England and has its main office in Glasgow, as well as an office in Amsterdam. Kinesys works with clients around the globe, but primarily in EU, UK and USA. Our work covers a range of product types (NCEs, biologics, ATMPS etc), a broad spectrum of therapeutic areas, and encompasses all stages of product development and development disciplines (CMC, Nonclinical and clinical).
The Principals at Kinesys each have over 30 years’ experience with large Pharma, Biotech companies and in consultancy. The Principals and Advisory Board members have all held senior commercial, regulatory or scientific roles at major pharma or biotech companies. Our staff are all either very experienced in regulatory affairs, medical writing or medical devices, and have specific knowledge of therapeutic areas, technical disciplines, or possess commercial / business expertise. Our experience is both broad and, in many areas, quite profound, including Orphan Drugs and specific therapeutic areas (e.g., Oncology / Haematology, CNS, Immunology, Ophthalmology).
Please apply to email@example.com with a CV and cover letter.
Full-time / Part-time Position
Kinesys was formed in 2007 as a successor to GMG BioBusiness Ltd, a successful Regulatory Affairs and Product Development consultancy set up in 1998 and acquired by a major CRO in 2005. Kinesys provides consultancy in the areas of Drug Regulatory Affairs, Medical Devices and Scientific / Regulatory Writing to clients around the globe. Kinesys’ services cover all types of pharmaceutical products, medical devices and biotechnology agents across most therapeutic areas.
Recent growth in our organisation has resulted in the need for a new consultant with specialism in the medical device sector. This post requires the successful candidate to have a practical working knowledge of medical device development, as well as the regulatory framework relevant to product development and quality management in the medical device sector. The role involves client facing work to support their quality and regulatory requirements.
Reporting to the Director of Medical Device, Quality and Regulatory Affairs, this post is ideally suited to candidates with a minimum of 7 years in quality or regulatory affairs roles, and recent management or consultancy experience in the medical device sector, and who are now ready to expand their knowledge and exposure to a wider range of product types and services. This is a new and exciting opportunity for a medical device specialist to become an active and vital member of staff within our growing company and expanding medical device team.
The successful candidate must have / be:
Desirable experience includes:
The post can involve travel to locations throughout the UK and abroad. Kinesys is taking a flexible approach to this position and will consider part-time and full-time options. Hybrid or home working may be available for the right candidate, at discretion of management.
Competitive salary, plus bonus and pension, commensurate with candidate experience and skill set. Continuous professional development.
Please send a full CV to firstname.lastname@example.org.