Documentation Specialist
: Job Details :

Job Description Tech-savvy information management specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems. Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. Provide routine user support. Electronic Document Management (controlled documents, regulatory submission documents): Be the first line of user support for Development users. Records Migration: Support necessary transfer projects from origination location to approved document management systems. Must be able to follow precise computer system instructions with high attention to detail and minimal oversight. Must balance priorities of several ongoing activities. Understanding of pharmaceutical and biological development processes and documentation is strongly preferred, due to the technical nature of the documents being managed. Demonstrated experience managing electronic document management systems, ideally in the Veeva suite of systems in a regulated laboratory environment. Preferably experience with Documentum, MS Teams, MS Sharepoint. Skills: 21CFR Part 11, GLP (FDA and EPA), GMP (FDA and EU), VICH Internal BI policies on Records Management, Training Management, Information Protection. The individual must be very detail oriented and able to follow precise instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly preferred. Must be able to create clear documentation and manage a workload of several assigned tasks. Education: Bachelor Degree + 2 years relevant experience OR Associates Degree + 2 years experience OR 4 years relevant experience Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.