Lead Regulatory Publisher

Job Description

  • Manage the day-to-day activities of direct reports, including project assignments and scheduling, create and maintain a detailed project timeline
  • Co-ordinate and maintain quality, productivity and timeline, adhere to internal or customer process and standards
  • Meeting regularly with the project teams to identify and resolve issues and to access quality, delivery and effectiveness
  • Responsible for publishing, dispatching and archiving of regulatory submissions in agency recommended formats
  • Responsible for supporting regulatory audits and related compliance activities
  • Ensuring timely delivery of high-quality regulatory submissions following client and internal processes
  • Prepare submission ready documents for electronic submissions including formatting, hyperlinking and processing MS Word and Adobe Acrobat documents
  • Developing and maintaining up-to-date knowledge of established agency standards and procedures for regulatory submissions
  • Troubleshoot document issues with Adobe Acrobat and MS Word
  • Manage technical aspects for assigned submissions and status updates
  • Collaborate with various department for planning, preparation, publishing and quality control checks of submissions.
  • Knowledge in using various Publishing and Validation tools
  • Required to participate in follow the sun hand-offs for submissions by partnering with publishers at other sites and time zones
  • Operating as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
  • Compliant with customer SOP's and Policies. Adherence to Organization's policies and procedures
  • Assist in revisions of department SOPs, Work instructions and training material.
  • Training and mentoring the team members, ensuring the staffs are trained with the expected job skills
  • Provide adequate support to team leads in updating the team members with project updates/work arounds for a technical scenario
  • Responsible for assisting team leads on the workload plan, project assignments/in understanding client requirements and ensuring on time delivery. Also manages day to day deliverables in team lead absence
  • Assisting team leads in analyzing and troubleshooting on the quality issues and providing resolutions/trainings

Desirable Skills and Experience

  • 7 to 10 years of experience in eCTD Submission Publishing is required. Experience with pharmaceutical/Life Sciences industry and in human drugs required
  • Computer and technical Skills
  • MS-Word, MS-Excel, MS-Access, PowerPoint, Adobe Professional Adobe reader, TRS Tool Box, eCTD Xpress, ISI publisher, Liquent IP (Insight Publisher), pharmaREADY, Validation tools

New Jersey/Pennsylvania, USA

Bachelor’s degree in a life sciences or technology-related discipline


Regulatory Affairs

6 month contract with the possibility of extension

12 Jan 2021