Posted over 5 years ago

Electronic Submissions Publisher Regulatory Remote/National, United States Description Veristat is expanding our presence from our home office in Boston, up to Montreal and Toronto, and down in Research Triangle Park. We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly managerial conversations. We invite you to learn more about us at our website www.veristat.com. The Electronic Submissions Publisher supports the Medical Writing and Regulatory Affairs team with the finalization and publishing of regulatory documents for electronic submission. S/he plays a crucial role in representing the regulatory operations group in publishing pivotal research documentation, and its timely delivery therein. As an Electronic Submissions Publisher You Will… Format documents in compliance with applicable regulatory agencies and sponsor requirements using Microsoft Word Create, assembles and publishes major and routine electronic submissions per regulatory and client requirements, including NDAs/BLAs, INDs, annual reports, supplements, amendments, etc. Serve as the coordinator for internal publishing activities, interacting with project teams to assist with timelines and deliverables related to submission documents and projects Interface with project managers and medical writers to discuss submission preparation and provide regular updates regarding deliverables Create submission planners for major submissions (per submission type) Maintain working knowledge of regulations governing the content and formatting of submission documents, as required by the FDA, ICH, and other regulatory bodies Perform quality control review tasks and administrative duties as requested Serve as the internal subject matter expert for training and support on publishing and formatting processes and software Experience + Requirements Bachelor’s Degree in a related field with 1-2 years of experience of electric submissions to the FDA and/or other health authorities required Proficient in Microsoft word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, ISIToolBox (Now TRS ToolBox; or other PDF processing plug-ins), and publishing software (e.g. Extedo, DocuBridge, eCTDXpress, etc.) Excellent writing skills (eg, English usage), a keen attention to detail, and strong verbal and interpersonal communication skills Ability to communicate and collaborate effectively in project teams Familiarity with medical terminology and statistical concepts