Department: Development Team
Job Title: Regulatory Operations Associate (LiveLink)
Description:
The Regulatory Operations Associate will perform activities associated with use and adoption of the Livelink document management system, regulatory document preparation and retention, and assistance with Livelink system training. This position requires a substantial amount of document filing, both electronic and paper.
Livelink Responsibilities:
Assist with performing Livelink GxP training and documentation.
Assist with the preparation of training materials as necessary.
Develop and test system work-flows.
Interface with users and IT to facilitate Livelink training, support and system management.
Complete Change Control forms for modifications to a GxP Livelink environment.
Facilitate transfer of sorafenib/Nexavar IND/NDA documents from partner company’s eRoom application to Livelink. Insure documents comply with designated naming convention and storage guidelines.
Collaborate with QA and other departments in the preparation of SOPs, work guidelines and training materials. Facilitate the flow of documents through the SOP approval process in Livelink.
- Act as first-line Livelink user support for all Onyx employees and consultants.
General Responsibilities: Maintain internal electronic and archival copies of submissions. Build and maintain filing systems for new molecules as needed.
Assist in the research and compilation of competitor information (e.g. regulatory authority databases) in support of project planning and development of regulatory strategy.
Monitor various regulatory agency websites for new regulations, guidance documents and pertinent agency meetings. Cross-reference results to enable competitive product and regulatory analysis.
Document scanning.
Creation, maintenance & formatting of MS Word templates.
Assist in the tracking of project and operational timelines related to regulatory submissions.
Other projects as assigned or requested.
Maintain content on the divisional intranet pages to improve and promote internal communications and facilitate dissemination of project information.
Job Requirements:
Two to six years’ experience in the pharmaceutical industry. Livelink experience preferred. Proficient use of technology including MS Office software package and Internet resources. - Motivated, self directed with a proven ability to work in a team environment.
- Strong written and verbal communication skills, good time management skills.
- Must be highly organized with excellent attention to detail.
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