Senior Regulatory Publishing Specialist - Submission Publishing

October 8

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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. • Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and security issues, under general supervision of the Manager, Electronic Publishing. • Maintains document life cycle for submission documents. • 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 or as the project team lead to evaluate and deliver publishing tasks. • Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed.

Requirements

• Submission Software experience is a must • Experience with Insight Publisher / eCTD Xpress / eCTD Manager/ Veeva Submission Publishing or docuBridge • Understanding how to build submissions, external linking, validation reports is highly desirable • 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 • 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 • Ability to create and follow timelines and conduct long-range planning • Ability to multi task 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’ comment • Ability to concentrate on the detail in a document without losing sight of the document as a whole