Specialist, Regulatory Compliance
- Employer
- Worldwide Clinical Trials
- Location
- Belgrade, Serbia;Homeworking
- Salary
- Competitive
- Start date
- 17 Mar 2023
- Closing date
- 27 Mar 2023
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
RESPONSIBILITIES:
Tasks may include but are not limited to:
- Receive, review, process and file essential documents, part of the Essential Document (ED) package agreed for the study, in accordance with applicable local regulations, internal SOPs and guidelines and ED Review Plan.
- Check the completeness of the ED packages as well as the quality of the documents provided
- Communicate corrective action and ensure issue resolution to meet documentation requirements as required, prior to approval of the ED packages and ED checklist sign off.
- Complete/updated relevant tracking tool on ongoing basis to allow visibility to project teams on the ED review progress status.
- Prepare and submits electronic copies of approved site ED, part of the ED Package for filing in Trial Master File, as applicable.
- Work with a variety of Electronic Document Management Systems to review and approve ED, as needed.
- Escalate any quality issues in a timely manner to relevant parties.
- Perform additional tasks as assigned by their Line Manager
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- English written and spoken, advanced level
- Strong organizational and time management skills
- Exercise sound judgment and ability to identify decisions requiring supervisory approval
- Handle multiple tasks with exceptional accuracy
- Computer literacy in Microsoft Word and Excel
REQUIREMENTS:
- University degree preferred (Life Science desirable) and 2 year of relevant experience or
- Combination of education and 3 years of relevant experience
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
#LI-MP2
#LI-Remote
#UncommonCRO
Company
Find out more about working for our company
Brief Company Description;
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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