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Proclinical are recruiting for an EU CTA to join a biotech organisation. This role is on a contract basis and is located in London.
- Accountable for evaluating and triaging requests for information from health authorities via CTIS for pertinent cross functional teams.
- Help the EU regulatory lead to prepare proposal content plans and documentation for regulatory deliverables, for the management of clinical trials.
- Support the definition, development and execution of procedures to meet the developing CTIS requirements.
- You will raise, notify and solve any concerns that might influence proposal procedures or timelines in CTIS.
- The ideal candidate will be allocated to one or more products under development to guarantee that clinical trial application approvals within the EU.
- Serve as a technical expert in the EMA clinical trial.
- Arrange for clinical trial submissions and notifications within a ground-breaking regulatory document management system and uphold tracking systems.
- Other duties may be assigned.
Key Skills and Requirements:
- Experience with using CTIS (Clinical Trials Information System).
- Familiarity with systems necessary to CTIS.
- Knowledge of Viva Volt
- Comprehension on EU clinical comprehension.
- Past involvement in a reg team admin / administrative assistant / clinical reg admin or similar role.
If you are having difficulty in applying or if you have any questions, please contact Dracen Black at firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.