Description
Essential Duties and Job Functions:
*As a member of the Regulatory Operations team, you will contribute to the routine submission compilation and publishing activities associated with generating hard copy and electronic submissions.
*Prepare a variety of routine submissions including utilisation of publishing tools for electronic and paper submission generation, scanning, QC, and electronic and paper archival in partnership with Central Records.
*Perform filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
*Support current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
*Perform work-flows and procedures regarding document tracking, indexing, retrieving and disseminating of FDA submissions as defined by Regulatory Operation management.
Knowledge, Experience and Skills:
*Good verbal, written, and interpersonal skills are required along with a good level of computer literacy, particularly with Microsoft Word and Excel.
*Works under general supervision for routine work and receives detailed instruction and close supervision for non-routine activities.
*Must have excellent attention to detail particularly when completing routine or repetitive tasks while still being able to meet strict and often tight deadlines.
*Should demonstrate flexibility and willingness to accommodate ad-hoc requests.
*A basic understanding of regulatory procedures, filing requirements and procedure time lines is required.
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.