Senior Regulatory Publishing Specialist - Advanced Word Formatting

October 7

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• The Senior / Regulatory Publishing Specialist provides experienced strategic, 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. • The focus of this role will be to support Word Formatting, Document Level Publishing, IMPD Publishing, and CSR Publishing for the client.

Requirements

• Strong knowledge of regulatory requirements and guidances for document management and electronic submissions. • Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools. • Advanced 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. • Advanced organizational skills and effective interpersonal skills. • Advanced analytical ability and problem-solving capabilities. • Strong knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies. • Advanced 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.