Regulatory Publishing Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future. Summarized Purpose: 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. Key responsibilities:Coordinates and manages client electronic submission deliverables supporting regulatory 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 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 with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the companys liaison for electronic submissions with the judgment within defined procedures and practices to determine appropriate the publishing needs in relationship to the overall project timelines quality and other project team members functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to independently within a project team to evaluate and deliver publishing to Success:Education and Experience: Bachelors degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years).In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the Skills and Abilities:Working knowledge of regulatory requirements and guidances for document management and electronic submissionsStrong knowledge of Microsoft (MS) Word MS Excel Adobe Acrobat electronic document management systems document publishing tools publishing systems eCTD validation and viewing toolsStrong knowledge of electronic templates and skilled in formatting and troubleshooting templatesAbility to manage several complex projects in parallel and adapt to changing prioritiesAbility to exercise independent judgment in developing methods techniques and evaluation of criteria using defined procedures and practicesAbility to independently assess sponsor needs and work with project team members in producing compliant deliverablesAbility to independently learn new technologiesStrong organizational skills and effective interpersonal skillsStrong analytical ability and problem-solving capabilitiesGood working knowledge of medical terminology statistical concepts and guidelines and requirements of the FDA and other international regulatory agenciesStrong editorial/proofreading skillsDetail-oriented thorough and methodicalAbility to create and follow timelines and conduct long-range planningAbility to multi task performing numerous single or complex tasks without ignoring overall objectivesAbility to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers commentsAbility to concentrate on the detail in a document without losing sight of the document as a wholeManagement Role:No management responsibilityBenefitsWe offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued. Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. 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