Principal Regulatory Publishing Spec

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Summarized Purpose :

Ensures the on-time delivery of a quality product to the sponsor. Assists in the management of projects in the provision of regulatory publishing and submissions services. Ensures successful regulatory review outcomes for product milestones. Serves in a quality review role and is responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations. Serves as liaison to internal

Essential Functions

• Prepares components of complex 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.
• Assists in the management of projects in the provision of regulatory publishing and submissions services.
• Acts as primary study contact or lead with internal and external clients.
• Provides leadership by participating in training, skill development, and mentoring of other regulatory publishing personnel, as needed.
• Assists in assessing sponsor needs and work with project team members in producing compliant deliverables.
• Serves in a quality review role thoroughly reviewing documents created within or outside of the company in order to ensure quality of a standard that meets or exceeds both client's expectations and federal requirements

Qualifications :

Education and Experience :

Knowledge, Skills and Abilities :

Skills Required

Adobe Acrobat, electronic submissions , Document Management, Xml, publishing systems