• Job Description

  Req#: R-01335305

  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:
  • Work is performed in an office/ laboratory and/or a clinical environment.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Exposure to electrical office equipment.
  • Personal protective equipment required such as protective eyewear, garments and gloves.

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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