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.
...Seeking a Diesel Pump Technician to work onsite and at customer locations (local/no overnight... ...and projects.Whats Needed?~ Mechanical Aptitude~2 years of industry... ...installation work (preferred)~ Prior forklift experience~ Ability to effectively...
Welcome To CommonSpirit Health Mountain Region CommonSpirit Health Mountain Region is committed to building healthier communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happenboth inside our hospitals and out in the...
...growth and transformation. As part of this expansion, we are seeking a forward-thinking Senior Talent Acquisition Manager to elevate recruiting strategy, implement AI-driven solutions, and help shape the future of the organizations workforce. Key Responsibilities...
...pharmaceutical, DME, and telemedicine/tele-health related companies. Hiring for part time, full... ...and on/off site facilities.Opportunities Entry level coders (USA, international companies)Senior CodersDirector of CodingManager, Coding and Abstracting (on site - 22...
...Company has partnered with an industry leader in enterprise Artificial Intelligence software and is seeking a highly skilled Site Reliability Engineer (SRE) to join our team to manage, monitor, and optimize our clusters on Kubernetes. Together were accelerating our client...