Senior Consultant – Regulatory Scientific Writing

Recruiter
Edward White
Location
High Wycombe
Posted
21 Mar 2019
Closes
31 Mar 2019
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Hobson Prior are currently seeking a Senior Consultant – Regulatory Scientific Writing position based in High Wycombe. Our client is an international consultancy organisation who specialise within the pharmaceutical industry, within this role you will plan and implement the writing strategy of regulatory documents for drug development, registration and maintenance activities across Europe and the US.

Job Responsibilities:


Manage the activities linked to the scientific support and writing of regulatory documents
Communicate with authors and clients
Advice and support on regulatory and scientific aspects to clients
Lead process of document reviews
Writing of scientific and regulatory documents



Actively participates in projects and responds to agencies questions



Key Skills:


Extensive experience in Scientific Writing
Excellent written and oral communication skills in English
Good organizational skills with the ability to work on multiple projects
Good analytical skills
Ability to work effectively within a team


Requirements:


Graduate in Pharmacist/Engineer/ Life Sciences
5-10 years of experience within Scientific writing especially within:
-Clinical Study Report (CSR)
-Paediatric Investigation Plan (PIP)/ Paediatric Study Plan (PSP) Orphan Drug Designation request (ODD)
-Briefing documents for scientific advice (EU, US)
-Orphan Drug Designation request (ODD)
-Paediatric Investigation Plan (PIP)/ Paediatric Study Plan (PSP), Investigational Medicinal -Product Dossier (IMPD)/ Investigational New Drug (IND)
-Investigator’s Brochure (IB)
-Clinical Study Report (CSR)
-CTD modules for MAA (or variations): Non-Clinical and Clinical Summaries and Overviews, Risk Management Plan


Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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