Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll 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. \nSummarized Purpose: \nProvides 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. \nKey responsibilities:\n•\tCoordinates and manages client electronic submission deliverables supporting regulatory compliance.\n•\tAssists 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.\n•\tEnsures 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.\n•\tAssists 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.\n•\tExercises judgment within defined procedures and practices to determine appropriate action.\n•\tEvaluates the publishing needs in relationship to the overall project timelines, quality and delivery.\n•\tEngages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery.\n•\tActs independently within a project team to evaluate and deliver publishing tasks.\nKeys to Success:\nEducation and Experience: \n•\tBachelor's degree or equivalent and relevant formal academic / vocational qualification\n•\tPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).\nIn 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 role.\nKnowledge, Skills and Abilities:\n•\tWorking knowledge of regulatory requirements and guidances for document management and electronic submissions\n•\tStrong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools\n•\tStrong knowledge of electronic templates and skilled in formatting and troubleshooting templates\n•\tAbility to manage several complex projects in parallel and adapt to changing priorities\n•\tAbility to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices\n•\tAbility to independently assess sponsor needs and work with project team members in producing compliant deliverables\n•\tAbility to independently learn new technologies\n•\tStrong organizational skills and effective interpersonal skills\n•\tStrong analytical ability and problem-solving capabilities\n•\tGood working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies\n•\tStrong editorial/proofreading skills\n•\tDetail-oriented, thorough, and methodical\n•\tAbility to create and follow timelines and conduct long-range planning\n•\tAbility to multi task performing numerous single or complex tasks without ignoring overall objectives\n•\tAbility to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers’ comments\n•\tAbility to concentrate on the detail in a document without losing sight of the document as a whole\nManagement Role:\nNo management responsibility\nBenefits\nWe 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!\nOur 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 100,000+ 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. \nApply today! http://jobs.thermofisher.com\nThermo 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 status.\nAccessibility/Disability Access\nJob 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 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.\nThis telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.