Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Regulatory Publishing Specialist
October 11
Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Description
• Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. • Ensures successful regulatory review outcomes for product milestones. • Serves in a quality review role and is responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations. • Coordinates and manages client electronic submission deliverables supporting regulatory compliance. • Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with sponsor and/or regulatory agency software programs meeting consistency and security issues. • Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of the Manager, Regulatory Publishing and assistance as appropriate from a Senior Regulatory Publishing Specialist. • Assists with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the company's liaison for electronic submissions with the sponsor. • Exercises judgment within defined procedures and practices to determine appropriate action. • Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery. • Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery. • Acts independently within a project team to evaluate and deliver publishing tasks. • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). • Working knowledge of regulatory requirements and guidances for document management and electronic submissions. • Strong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools. • Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates. • Ability to manage several complex projects in parallel and adapt to changing priorities. • Ability to exercise independent judgment in developing methods, techniques, and evaluation of criteria using defined procedures and practices. • Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables. • Ability to independently learn new technologies. • Strong organizational skills and effective interpersonal skills. • Strong analytical ability and problem-solving capabilities. • Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies. • Strong editorial/proofreading skills. • Detail-oriented, thorough, and methodical. • Ability to create and follow timelines and conduct long-range planning. • Ability to multitask performing numerous single or complex tasks without ignoring overall objectives. • Ability to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers’ comments. • Ability to concentrate on the detail in a document without losing sight of the document as a whole.
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