Senior Reg Publishing Specialist

Work Schedule

Other

Environmental Conditions

Office

Job 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 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:

• Bachelor's 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! http://jobs.thermofisher.com

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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