Regulatory Affairs Consultant-Clinical Writer (vaccines/ biologics)
Parexel International Corporation
United Kingdom - Any Region - Home Based
We have a number of opportunities for Clinical Writers/ Regulatory Affairs professionals with clinical writing experience to join Parexel and partner with one of our prestigious clients.
This role can be based in several European countries and is available on different seniority levels.
A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides. A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, a Consultant assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations.
Regulatory Affairs Consultant will have the following responsibilities: Support US/EMA submissions and CTA Writing of key technical documents / sections. Writing of clinical consultation/answers to questions Ensuring the coordination with the departments involved in the writing/review process 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) Ensuring the coordination with the departments involved in the writing/review process QualificationsThe ideal candidate will possess: 5 to 10y of experience in Regulatory Affairs in leading development, including the writing of technical documents. Bachelor 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 a new area.