Regulatory Documentation Specialist II

Position Summary

The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation and will provide support in the management and publishing of documents ensuring its conformance with Health Authority requirements. This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.

Essential Functions

• Create and maintain electronic project folders for projects
• Create electronic files for working documents
• Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
• Format and compile documents according to requirements specified by Regulatory Agencies
• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone
• Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
• Prepare document shells for inclusion of text and data
• Afford assistance in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Education & Experience

• Bachelor’s Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
• High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required.

Knowledge, Skills, & Abilities

• Working knowledge of Health Authority procedures and guidance regarding document management and electronic submissions
• Working knowledge of Electronic Document Management Systems
• Working knowledge of Veeva Vault especially Veeva RIM
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail

Working Environment / Physical Environment

• This position works on-site (Monday through Friday) in Summit, NJ.
• Regular work schedule is Monday – Friday, within standard business hours.
• Flexibility is available with manager approval.
• This position may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with colleagues throughout the day, often on a project-team basis.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays