Senior Reg Publishing Specialist
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
OtherEnvironmental Conditions
OfficeJob Description
Summarized Purpose:
This is an outstanding opportunity to join Thermo Fisher Scientific as a Senior Reg Publishing Specialist. You will play a pivotal role in ensuring flawless regulatory review outcomes for key product achievements. Your expertise in preparing client electronic submission deliverables and dossiers will help us to successfully implement projects that meet or exceed client this role you will be at the forefront of delivering world-class regulatory compliance solutions.
Essential Functions:
- Provides expertise in client submission deliverables supporting regulatory compliance.
- Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory mentorship.
- Maintains document life cycle for submission documents.
- Leads the development and implementation of project-specific processes for sponsors with outstanding technology requirements.
- May act as the companys liaison for regulatory submission with the sponsor.
- Provides leadership by participating in training skill development and mentoring of other electronic submission personnel.
- 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 vital to deliver final product and resolve/mitigate identified issues.
- Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks.
Qualifications:
Education and Experience:
- Bachelors degree or equivalent experience and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
Knowledge Skills and Abilities:
- Strong knowledge of regulatory requirements and recommendations for document management and electronic submissions.
- Advanced knowledge of Microsoft (MS) Word MS Excel Adobe Acrobat electronic document management systems and publishing tools.
- Ability to manage several complex projects in parallel and adapt to changing priorities.
- Sophisticated organizational skills and effective interpersonal skills.
- Solid understanding of medical terminology and regulatory guidelines.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific provides 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!
Apply today!
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.
Accessibility/Disability Access
Thermo Fisher Scientific provides accessibility services for applicants needing accommodations during the job application process. This support is available for individuals with hearing vision mobility or cognitive impairments. If you have a disability or are helping someone with a disability and need assistance to apply please call 1-*. Include your contact details and information about the accommodation you require.
This phone line is dedicated exclusively to job applicants with disabilities who need accessibility help or accommodations during the application process. Calls about other issues like trouble accessing the career site application follow-ups or unrelated technical problems will not be answered.
Required Experience:
Senior IC
Key Skills
- Computer Hardware
- Mac Os
- Manufacturing & Controls
- Root cause Analysis
- Windows
- Customer Support
- Remote Access Software
- Operating Systems
- Encryption
- Remedy
- Chemistry
- Cerner
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
