Preclinical / Clinical Project Administrator 12 months FTC Pharma -Cambridge, UK Office-based. One of our fastest growing partner is looking to strengthen their team with...
Preclinical writer, scientific writer, Permanent, Office-based, Pharma, Cambridge, UK.
One of our fastest growing partner is looking to strengthen their Preclinical Department with the appointment of a Preclinical Writer in their office in Cambridge.*Permanent role*Fast growing pharmaceutical company*Excellent benefits package*Multicultural team culture The preclinical writer will ensure preclinical data are available, identified and appropriately assembled for regulatory submissions throughout the product life cycles, including arranging and authoring of preclinical regulatory documents. This is unique opportunity to join an exciting and innovative place to work, with an excellent benefits package and a strong team culture!About SRGSRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.Key Responsibilities*Prepare relevant preclinical sections of documents for Regulatory submissions, includingInvestigationalNew Drug applicationsClinical Trial ApplicationsNew Drug ApplicationsMarket Authorisation ApplicationsOrphan Drug ApplicationsInvestigator Brochures*Maintains an up-to-date knowledge of regulatory guidance to ensure appropriate preclinical data are available for regulatory submissions*Prepares and manages the preparation of preclinical sections of briefing documents for meetings with competent authorities*Coordinates with Regulatory Affairs Department*Contributes to the preparation of SOPs for the Preclinical Department*Organises quality control of required documents and / or sections as appropriate
REQUIREMENTS*A graduate degree in a Science/Life Science*Good previous experience writing and reviewing preclinical study-related documents within Pharma*Ability to plan and communicate clearly *Working knowledge of Word, Excel, PowerPoint, Endnote and search engines*Knowledge of appropriate regulatory guidelines and legislation
HOW TO APPLY?Click on the "apply" button below. Please contact Arnaud Heroult on +44 (0)203 096 4712 or email if you would like to know more about this opportunity.Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical Affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 096 4712.Key words:CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Medical Device, Permanent, Freelance, Contract, Part-time, Temporary, Clinical Research, Administrator, Assistant, CTA, Clinical Trial, Associate, Project Management, Senior, Manager, Career, Clinical Research Associates, CRA, SCRA, Clinical Monitoring, Site Monitor, Site Manager, CPM, Clinical Trial Manager, Study Director, Project Leader, Diagnostics, In-Vitro, IVD, Laboratory, Reagents, Non-interventional, Therapeutic Areas, Indication, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, haematology, orphan diseases, nephrology, musculoskeletal, endocrinology, gastroenterology, clinical research nurse, clinical educator, medical writer, medical information, preclinical, regulations, databases, regulatory affairsThe recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.