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Regulatory Affairs CRO Associate - Rare Diseases

Employer
NonStop Consulting
Location
Berkshire
Salary
Negotiable
Closing date
Mar 24, 2019

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Sector
Science, Life Sciences, Genetics
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice
Jobseeker Type
Professional

Job Details

NonStop Pharma are currently working with a small, growing CRO to source a Regulatory Affairs Associate.

Working with mid size Biotech clients predominately, this is a great opportunity to join an exciting Contract Research Organisation. Stepping in as an Associate, you will be heavily involved in work with a range of clients, namely working with Rare Disease Products and Orphan Drugs.

You will be joining a small, close knit team of 10 Regulatory professionals in Berkshire.

Benefits:

- Voted one of the top CROs to work for last year
- Join a small, family focused team environment
- Great company culture
- Work with rare disease products & innovative biotechs across a broad client range

Position Requirements (knowledge, education, qualifications, number of year's experience etc.)

  • BSc degree in life sciences.
  • 5 or more years monitoring in clinical research experience: experience in pharmaceutical or biotechnology companies but preferably in a CRO
  • IMP trial experience is mandatory. Medical device experience and monitoring of non-IMP trials are not acceptable without recent IMP experience.
  • Therapeutic area: Oncology experience is highly recommended. Other TA experience should ideally encompass complex indications and/or rare disease and/or trials in ICU settings.
  • Current knowledge of ICH GCP
  • Awareness of global regulatory and pharmacovigilance environments
  • Fluent English. Local language is mandatory for positions outside the UK.
  • Excellent communication skills, written, oral and presentation
  • Excellent organisation and time management skills
  • Proactivity and risk management skills
  • Excellent computer skills
  • Ability to drive
  • An ideal candidate may also have: An MSc of PhD in a related field, Experience in EDC & CTMS, Experience in site selection, Experience in contracts negotiation, Experience in EC & CAs submission preparation

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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