Bachelor’s or master's Degree in Life Sciences or equivalent.
♦ Experience in HGRAC and CTA/IND appication preferred.
♦ Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions through such tasks as entering information into Tables of Contents and creating tabs and submission labels.
♦ Provide support assistance to senior staff in the upkeep of regulatory authority submission and correspondence logs (add entries to Tables of Contents, file submission letters and other correspondence).
♦ Generate routine submission cover letters to regulatory authorities and clients.
♦ Track, inventory and organize individual components of regulatory submissions.
♦ Perform document acceptability checks of submission components.
♦ Liaise with the Publishing group in the generation of submissions.
♦ Provide support assistance to senior staff in the oversight, final preparation and generation of submission documents.
♦ Perform a quality check of final submission documents.
♦ Update status reports and tracking sheets of ongoing and pending regulatory projects with input provided by senior staff.
♦ Organise shipping of documentation to clients, regulatory authorities and within Covance.
♦ Perform other job functions, such as word processing, as needed to accomplish the above listed duties.
♦ Perform other activities as required by management
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