Sr Reg Publishing Spec

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions and Other Job Information :

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

Qualifications :

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).

Working Conditions and Environment :

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