International Documentation Specialist

What you'll be doing: Interact with internal cross functional groups to satisfy market specific information requirements. Build expertise in utilizing/querying systems (e.g. GSS, APR, Optiva, connect MSDS, etc.) and contacting appropriate departments (e.g. scientific formulators, technical transfer, quality assurance, R&D, regulatory liaisons, legal, third party manufacturing sites & contract manufacturing, etc.). Assure that the correct formula is identified and attached to the certificate and consistent with the label. Resolve any label to formula discrepancies. Significant amount of contact with international markets to clarify requirements, receipt of information, and critical timelines. Work with IT to migrate from access database to new enterprise solution (SharePoint).Contribute to system design, data validation and expansion of US SharePoint to international regions. Participate on project team for global initiative in support of KPI 11. As an assigned regional champion schedule/lead monthly call with region, monitor request status on a daily basis, summarize status at weekly team meetings and resolve all outstanding issues. Provide input/draft SOP for robust process. Actively identify and implement process improvements. Measure results against prior performance metrics. Support the upload of documents/product dossiers to connect. Lead assigned ad-hoc projects e.g. sun block labeling, dual manufacturing initiatives, border hold documentation, etc.

What your background should be: At least 2 years related experience. Clinical research experience within the pharmaceutical industry. Strong analytical & problem solving skills, excellent communication, software expertise, and the ability to work with a large volume of data. Course work and/or working knowledge of chemistry and prior regulatory experience desirable. Strong project management to provide oversight of the change control process, the content and timing of request. Ability to manage functional system issues. Subject matter expertise required as it relates to the knowledge of compliance guidance documents in the various systems. Excellent organizational and IT skills. Excellent communications skills and the ability to work under pressure until project completion. Exhibit ability to manage multiple projects and communicate with various departments. Proficiency in Microsoft Word and Excel are required. Must be able to prioritize and make quick decisions.

Who is the client company: This is an American temporary staffing agency that operates throughout the world.; If you are interested in this position, send your resume to apply@kochdavis.com