Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Essential Functions and Other Job Information:
Coordinates and manages client electronic submission deliverables supporting regulatory compliance.
? Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with sponsor and/or regulatory agency software programs meeting consistency and security issues.
? Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of the Manager, Regulatory Publishing and assistance as appropriate from a Senior Regulatory Publishing Specialist.
? Assists with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the company's liaison for electronic submissions with the sponsor.
? Exercises judgment within defined procedures and practices to determine appropriate action.
? Evaluates 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 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 2+ 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.
Recuerda que ningún reclutador puede pedirte dinero a cambio de una entrevista o un puesto. Asimismo, evita realizar pagos o compartir información financiera con las empresas.