Senior Reg Publishing Specialist

Senior Reg Publishing Specialist

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 expectations. In 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 company's 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 :

Knowledge, Skills and Abilities :

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!

Accessibility / Disability Access

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