Sr Reg Publishing Spec

Work Schedule

Environmental Conditions

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 companys liaison for regulatory submission with the sponsor and assist the companys 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:
Bachelors 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.