Regulatory Publisher

Job Title: Regulatory Publisher

The Regulatory Publisher works closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to both regulatory health authority and company guidelines for electronic submissions. The incumbent will support global process; executing end-to-end submission assembly which includes publishing, quality control verification, finalization, and delivery. This requires collaborative interaction with component providers and submission managers to ensure quality, right first-time output and timeliness. Additionally, the incumbent may be involved in assisting with developing administrative documentation, providing inter-departmental and/or external stakeholder mentoring, as well as involvement with the testing and implementation of new systems, tools, and processes.

Job Description:

• Work closely with submission managers to produce high quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines
• Ensure submission assemblies meet the level of technical integrity required for our company and health authority validation tools
• Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies
• Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions
• Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
• Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools
• Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders
• Identify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard procedures

Requirements/Qualifications:

• High school diploma or equivalent plus 3 years of regulatory publishing experience; Bachelor’s degree plus 2 years of regulatory publishing experience preferred
• In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional
• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
• Demonstrates the ability to independently solve a range of straightforward problems that arise within job responsibilities and expectations
• Effectively communicates difficult issues both verbally and in writing and persuades others in straightforward situations
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures 

Job Type: Full-Time; occasional weekend and evening hours

Location: San Diego, CA (Work Remotely due to COVID-19)

Work Remotely:

• Temporarily due to COVID-19
• This position will be based out of our San Diego, California office. Due to the COVID-19 pandemic, this position does not currently require regular in-office work (unless otherwise directed) until after Jan, 2022 at the earliest. Employee will primarily work with our internal Project Managers and Analysts. At present time, we have discouraged travel, however, as COVID-19 restrictions are lifted, some local travel may be required, with additional limited overnight travel.
• Travel
  • Must be able to travel by car/air to other CrO Biosciences meetings and events as needed.

COVID-19 Precaution(s):

• Remote interview process