Regulatory Clinical Writer Consultant (Vaccines/Biologics) – Global CRO – Remote (UK / EU only) - £competitive, bonus, benefits
This is an exciting time to join this market leading, global CRO based in the UK / EU. You’ll be predominantly support US/EMA submissions and CTA’s as well as writing of key technical documents / sections.
A global, well known CRO are now recruiting for a Regulatory Consultant (Vaccines / Biologics) to join their already well-established team. Offering great training and development, this company has a huge interest in developing their employees to a high standard.
- Global CRO
- Working across exciting vaccines / biologic projects with one major client (global pharma)
- Very exciting projects to work on and upcoming pipeline
- Excellent career progression opportunities to Senior Manager, Associate Director and beyond
- Great training and development
Working on a number of exciting projects and with an exciting pipeline, the Regulatory Clinical Writer (Vaccines / Biologics) will be responsible for;
- Support US/EMA submissions and CTA
- Writing of key technical documents / sections.
- Writing of clinical consultation/answers to questions
- Writing clinical parts of regulatory first files, life cycle variations/supplements for all destinations (Modules 2 & 5)
- Writing Responses to Questions raised by Regulatory Authorities on clinical, epidemiological and safety matters
- Writing Briefing documents for regulatory consultations
- Writing paediatric investigation plan (PIP)/ paediatric study plan (PSP)
To apply for this role as Regulatory Clinical Writer (Vaccines / Biologics) our client is hoping for someone with the following skills and experience
- Experienced Regulatory Affairs professional including writing of technical documents.
- BA degree or PhD in science/biological or healthcare
- Strong clinical development/ICH E6/GCP understanding
- Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
- Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
- Extensive knowledge of being able to develop product / therapeutic knowledge in new area.
What should you do next?
This Regulatory Clinical Writer (Vaccines / Biologics) role is one not to be missed; it encompasses the opportunity to work on a highly successful team on some new and exciting products.
To discuss this Regulatory Consultant (Vaccines / Biologics) role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.