Senior CRA - UK
ProClinical is currently recruiting for a Senior CRA position with an international contract research organisation. This company, which prides itself on providing drug discovery, lifecycle management, and laboratory services, is looking for experienced CRAs to join their growing UK-based team.
The Senior CRA will provide effective regulatory support, including submissions of clinical trial authorisations, their maintenance, and life cycle management.
- Writing high-quality CMC documents during development, product registration, and product maintenance.
- Providing advice on CMC regulatory strategies.
- Supporting regulatory compliance activities.
- Identifying the required documentation for CMC submissions; negotiating the delivery of approved technical source data and documents in accordance with project timelines.
- Working with R&D and Quality colleagues to ensure documentation needs meet EMEA CMC regulatory requirements.
- Preparing and reviewing CMC responses to health authority questions during development, registration, and product lifecycle.
- Creating supporting documentation to ensure successful product lifecycle management.
Skills and Requirements:
- A university degree in a life-sciences field.
- At least 2 years of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation.
- Demonstrable understanding of ICH-GCP, EU, and FDA requirements.
- Demonstrable understanding of medical/therapeutic area knowledge and medical terminology.
- Exceptional communication, organisational, and time management skills.
- An ability to work in a team or independently, as required.
- Proficiency in computer software, such as MS Office, and able to learn new software as appropriate.
- Fluency in English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 752 0314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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