Draft and perform quality check of technical documents (supporting documents protocols protocol amendments reports standard operating procedures dossiers position papers templates and SIPs) for formats styles compatibility etc. as appropriate Correspond with contract research organizations (CROs) FMC study monitors and product technical experts (PTEs) or country regulatory managers (CRMs) to confirm and resolve document issues and guideline discrepancies and external suppliers Create electronic document versions (Word PDF etc.) Import documents into Veeva Regulatory One following all appropriate document management rules Define metadata (properties) for each document and align according to database standards Preform advanced searches in Veeva RegulatoryOne Maintain templates based on current standards and guidelines
Education/Role Qualifications & Years of Experience:
Masters degree in science biology chemistry or equivalence in experience 1-5 years of experience managing technical documents. Strong computer and MS office skills particularly Word (styles and format) and PDF. Should possess SharePoint knowledge Must possess some understanding technical documents Understanding of content management file structure Must be fluent in English (both oral and written) with ability to express ideas and thoughts effectively to supervisor technical experts and peers. Organized detail oriented work independently Comfortable working with people from different countries and cultures. Team player networking and interpersonal skills are necessary Able to follow established business rules processes and structure Ability to work under deadline pressure Must show abilities to proactively resolve conflict and issues to ensure business continuity
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.