Thermo Fisher Scientific

Compensation

Full Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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.