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.
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Within our Regulatory Affairs team, we have a functional service provider solution, which is a unique partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working with a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Sr/Principal RegulatoryPublishingSpecialist - Submission Publishing (FSP)
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
Major responsibilties:
- Submission Software experience is a must
- Experiennce with Insight Publisher / eCTD Xpress / eCTD Manager/ Veeva Submission Publishing or docuBridge
- Understanding how to build submissions, external linking, validation reports is highly desirable
- Provides expertise in client submission deliverables supporting regulatory compliance.
- 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.
- Leads the development and implementation of project-specific processes for sponsors with unique technology requirements
- May act as the company's liaison for regulatory submission with the sponsor and assist the company's project teams in executing regulatory submission strategies
- Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed.
- Uses professional judgment to evaluate 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 or as the project team lead to evaluate and deliver publishing tasks.
Education and Experience:
- 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 5+ 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 role.
Knowledge, Skills and Abilities:
- 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 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
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 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.
Thermo 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.
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