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Introduction to Employment Positions and Contracting with Kinesys Consulting Ltd

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.

Regulatory and Scientific Writer

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

Job Requirements

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.

  • 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 Preclinical, 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.

Please send a full CV to info@kinesysconsulting.com.

Senior Regulatory Affairs Consultant

Profile of person for the role

  • You must be located within UK or EU
  • University degree or PhD in pharmacy, chemistry, medicine or a biological science.
  • Minimum 8 years in a pharmaceutical or biotechnology company, or in a regulatory agency role.
  • Proven experience of working independently; able to demonstrate initiative and ability to multi-task, plan and work in a team.
  • Management experience not essential but valued.
  • Excellent understanding of EU regulations, processes and procedures. FDA also of interest but not essential.
  • Proven experience of engaging with regulatory agencies through submission of regulatory applications (Scientific Advice, MAAs, ODDs, PIPs, CTAs etc).
  • Highly computer literate, possesses good analytical skills and attention to detail.
  • Excellent communicator.
  • Excellent organisational and project management skills and ability to prioritise and work diligently to tight deadlines.
  • You are looking for a company where you will broaden your experience and grow with the company.
  • You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.
  • Excellent command of spoken and written English. Other languages highly valued.

Responsibilities of the Role

  • Ability to apply knowledge of legislation and guidance relevant to manufacture and development of pharmaceutical and biotechnology products to our clients’ products and projects.
  • Provide regulatory strategy advice to Kinesys clients.
  • Project management of regulatory applications and procedures for clients.
  • Analysis of regulatory information, plus CMC, nonclinical and clinical data, related to a range of Regulatory Applications, where appropriate.
  • Oversight and review of regulatory submissions, primarily to EMA, FDA, and National Competent Authorities in EU as well as other regulatory / technical documentation, including:
    • Scientific Advice applications
    • Orphan Drug Applications
    • Clinical Trial Applications
    • Paediatric Investigation Plans (PIPs)
    • Expedited Pathway Applications (PRIME, PIM, Breakthrough Therapy, Fast Track etc)
    • Marketing Authorisation Applications / New Drug Applications
    • Variations and Line Extensions
    • Regulatory Roadmaps

You will also have:

  • Excellent written and spoken English.
  • A commitment to producing high quality deliverables.
  • The ability to work efficiently prioritize time between multiple projects.
  • Excellent communication skills, to support collaborative relationships with colleagues and clients.

More about Kinesys Consulting Ltd…

History

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).

Services

  • Regulatory Affairs Strategy and Submissions
  • Medical Writing
  • Medical Devices

Kinesys People

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 info@kinesysconsulting.com with a CV and cover letter.

Medical Devices Consultant

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:

  • A degree or equivalent in a scientific or engineering discipline.
  • 7+ years’ work experience in medical device quality or regulatory affairs.
  • Knowledge and understanding of the regulatory framework for approval of medical devices in the UK and EU. Knowledge of the US devices environment would be an advantage. 
  • Experience implementing and maintaining an ISO 13485 compliant QMS.
  • Adaptable and able to apply analytical skills in diverse situations.
  • Dynamic with a strong customer focus, exceptional communication and computing skills, and be a strong team player.
  • Experience with auditing.
  • Experience in generating Product Conformity Documentation.
  • Able to live and work in the UK and have a full driving licence.

Desirable experience includes:

  • Knowledge of software as a medical device.
  • Experience with IVDs and companion diagnostics.

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.

Compensation package

Competitive salary, plus bonus and pension, commensurate with candidate experience and skill set. Continuous professional development.

Please send a full CV to info@kinesysconsulting.com.

Spontaneous Application

Are you looking for a consultant or contractor position? If so, please follow the instructions below:

  1. Please send a full CV to info@kinesysconsulting.com.
  2. Please include a cover letter setting out a short description of your profile and experience, the type of position that you are seeking (role, contract duration, geographical preference, expected salary / fee) and any other relevant information.
  3. Kinesys will then contact you to conduct a short interview and to discuss further your objectives and potential roles.