Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeEssential 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 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
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 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.
DescriptionJob Title: Remote Clinical Counselor**This position is fully remote and able to be supported from any location. However, candidates... ...regions virtually, and in times of crisis may be required to travel to provide clinical support to clients on site.Essential...
...Removable Dental Technician Spokane, WA Compensation: $25$35 per hour Schedule: Full-time, on-site Overview Our Spokane-based dental laboratory is expanding and seeking a skilled Removable Dental Technician to support our growing removable department....
...quirks and contradictions. The host will serve as the key voice and face of the local brand across all platforms including the daily podcast, video, and social media and must be excited to explore different points of view about the issues shaping the city. What Youll...
...our payroll operations from home. This part-time role... ...income with 3-4 hours of work daily. No prior payroll experience is necessary as comprehensive... ...check vouchers and related data into accounting systems... ...general administrative and data entry tasks as needed What We...
...Firmware/Embedded Engineer Intern - Communications - Summer 2026 OTTO's opportunity: OTTO Communications designs and manufactures innovative two-way radio products for demanding and mission-critical applications. For over 60 years, OTTO's products have been recognized...