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.
...About us: Do you love storytelling and want to make a lasting impact on students' lives? Vanguard College Prep is seeking full-time Essay Specialists to help high schoolers craft authentic, powerful application essays. Our specialists don't just edit words they shape...
...80 countries collaborate to win on the digital shelf. As the market leader globally, our... ...contribute to its growth through community, content, and education. In the digital age,... ...the companys goals and objectives Managing and growing our online community...
...eligibility of selected candidates through the Department of Labors - E-Verify. H2 Performance Consulting (H2) is seeking a SharePoint Developer to provide support to the Administration and Resource Management Division (ARI) within Headquarters Marine Corps (HQMC). The...
...support team. In this role, you will assist customers through live chat, email, and occasional phone support while providing a... ...If you enjoy problem-solving, communicating with people, and working from home, this role is a great fit.Key Responsibilities:~Respond promptly...
...and in-service training and performs other duties as assigned.Requirements:Graduate from an accredited school of practical nursing or vocational nursingLVN License in state of employment or compactBLSWork Schedule: 8AM - 5PM Monday-FridayWork Type:Full Time...