Document Specialist - Regulatory

Avetix Bio; Summit (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing of regulatory documents ensuring conformance with Health Authority requirements. The role supports staff in document management and coordinates eCTD modules.

The ideal candidate has a Bachelor’s degree in life sciences or technical discipline and 5+ years of regulatory operations experience, with expert knowledge of Health Authority procedures and Veeva Vault (RIM).

Qualifications

• Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission.
• Strong knowledge of Electronic Document Management Systems.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.

Responsibilities

• Create and maintain electronic project folders for projects.
• Maintain Veeva RIM by uploading submission materials and Health Authority correspondence.
• Serve as advisor to internal departments in preparation and submission of regulatory documentation.
• Format and publish documents for regulatory submissions and reports.
• Prepare templates and document shells for inclusion of text and data.
• Train Regulatory Documentation Specialists on SOPs and processes.
• Collaborate on software upgrades and continuous improvement of documentation systems.

Skills

Regulatory knowledge

Veeva Vault

Documentation accuracy

Education

Bachelor’s degree in life sciences or technical discipline

High school diploma with 9+ years regulatory operations experience

Tools

Veeva RIM

Job description

The Specialist III, Regulatory Documentation will report to the Director, Regulatory Documentation and will provide expertise and guidance in the management and publishing of documents ensuring their 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
• Maintain Veeva RIM by uploading all submission, Health Authority correspondence, etc.
• Serve as an advisor to internal departments in the preparation and submission of regulatory documentation
• Generate 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
• QC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by others
• Create new submissions in submission software following all SOPs and ensuring all checklists are completed
• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone
• Submit documents to Health Authorities.
• Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
• Prepare templates and document shells for inclusion of text and data
• Assist 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
• Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed
• Performs 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 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
• High school diploma with 9+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required

Knowledge, Skills, & Abilities

• Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission
• Expert knowledge of Electronic Document Management Systems
• Strong knowledge in Veeva Vault especially Veeva RIM
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities