NJ Employer Contractor - Reg. Affairs Publishing - eCTD Submissions Coordinator in New Jersey
Contractor - Reg. Affairs Publishing - eCTD Submissions CoordinatorThe Reg. Affairs Publishing - eCTD Submissions Coordinator will support the preparation of electronic regulatory submissions, and the submission of these documents through the FDA Electronic Submission Gateway (ESG,) as well as traditional paper submissions. The scope of this role includes assisting in the support of associated computer systems and communicating with Medical Affairs, Quality Control, Regulatory Affairs and others to ensure submissions are complete and formatted correctly according to standard operating procedures.RESPONSIBILITIES Publish and submit IND and NDA applications, amendments, supplements and annual reports pertaining to on?going application maintenance in accordance with established timelines and submission dates in a compliant manner. Coordinate with other departments to gather all necessary documents for FDA submissions. Confirm proper formatting and linking of eCTD documents and backbone. Support Regulatory Affairs during submission processing. Provide technical guidance and training to other team members in electronic submissions and the eCTD system. Achieve and maintain subject matter expertise in CTD, eCTD and electronic submissions. Maintain general knowledge in FDA & EMA regulations and ICH guidelines. Provide general assistance to other team members as needed. Organizing electronic documentation. Filing and organizing of Regulatory documentation.MINIMUM JOB REQUIREMENTS Must have a Bachelors degree or equivalent industry experience. Familiarity with computer systems, Adobe Acrobat Standard and Microsoft Office. Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.PREFFERED SKILLS AND EXPERIENCE Working knowledge of FDA submission requirements. Demonstrate high level skills with MS Word, Excel, PowerPoint and Outlook. Experience with Oracle or other database systems. 6 months of experience, or greater. Experience with any eCTD publishing tools, such as: ISI Toolbox, eCTDXPress, docuBridge, GlobalSubmit.To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html -- and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.