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**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Job Description**:**Summarized Purpose**:Provides moderate, expedient, and efficient preparation of client electronic submission deliverables anddossier that meet current local, regional and ICH regulatory and technical requirements.
Ensuressuccessful regulatory review outcomes for product milestones.
Serves in a quality review role and isresponsible for the thorough review of documents created within or outside of the company to ensurequality of standards meet or exceed client expectations.
**Essential Functions and Other Job Information**:**Essential Functions**Coordinates and manages client electronic submission deliverables supportingregulatory compliance.Assists in preparing electronic document outputs that meet requirements forregulatory publishing to include documents that work with sponsor and/orregulatory agency software programs meeting consistency and security issues.Ensures that all final electronic deliverables meet current regulatory electronicdocument requirements and guidance under general supervision of the Manager,Regulatory Publishing and assistance as appropriate from a Senior RegulatoryPublishing Specialist.Assists with developing and implementing project-specific processes for sponsorswith unique technology requirements and may act as the company's liaison forelectronic submissions with the sponsor.Exercises judgment within defined procedures and practices to determineappropriate action.Evaluates the publishing needs in relationship to the overall project timelines,quality and delivery.Engages other project team members, functional units or publishingmanagement as necessary to deliver final product and resolve/mitigate identifiedissues or barriers to delivery.Acts independently within a project team to evaluate and deliver publishingtasks.
**Job Complexity**Works on problems of moderate scope where analysis of situations or data requiresa review of a variety of factors.
**Job Knowledge**Developing professional expertise, applies company policies and procedures toresolve a variety of issues.
**Supervision Received**Normally receives general instructions on routine work, detailed instructions on newprojects or assignments.
Exercises judgment within defined procedures andpractices to determine appropriate action.
**Business Relationships**Contacts are primarily internal to the company with infrequent external customer /vendor contact on routine matters.
Builds productive internal / external workingrelationships.
**Qualifications**:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to2+ years)