Regulatory Publishing Specialist
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Coordinates and manages client electronic submission deliverables supporting regulatory compliance.
- Assists 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.
- Ensures 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.
- Assists 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.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Evaluates 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 to evaluate and deliver publishing tasks
Requirements
- 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 2+ years)
- Working knowledge of regulatory requirements and guidances for document management and electronic submissions
- Strong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools
- Strong 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
- Strong organizational skills and effective interpersonal skills
- Strong analytical ability and problem-solving capabilities
- Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies
- Strong 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’ comments
- Ability to concentrate on the detail in a document without losing sight of the document as a whole
Benefits
- Accessibility/Disability Access
- EEO
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancedocument managementelectronic submissionseCTD validationtemplate formattingtroubleshootingproject managementanalytical abilityproofreadingmedical terminology
Soft skills
independent judgmentorganizational skillsinterpersonal skillsproblem-solvingdetail-orientedmethodicaltime managementmulti-taskingadaptabilitycommunication
Certifications
Bachelor's degreevocational qualification