.**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Summarized Purpose**:Provides experienced strategic, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. 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.**Essential Functions and Other Job Information**:**Essential Functions**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.**Job Complexity**Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.**Job Knowledge**A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.**Supervision Received**Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.**Business Relationships**Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters, often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise