Veeva RIM Specialist

Scorpion Therapeutics; Summit (NJ); On-site; USD 95,000 - 135,000; Full time

Job summary

Scorpion Therapeutics is seeking a Veeva RIM Specialist to manage regulatory documents and ensure conformance with Health Authority requirements. You will support US and ex-US regulatory activities, maintain an inspection-ready system, and assist with submissions using Veeva RIM.

The role emphasizes hands-on document management, lifecycle tracking, and collaboration with Regulatory Affairs, IT, and clinical teams to translate business needs into technical solutions.

Qualifications

• Bachelor’s degree in life sciences/technical discipline with 5+ years regulatory operations experience in biotech/pharma or High School diploma with 9+ years.
• Hands-on experience with Veeva RIM and Veeva Vault.
• Global regulatory submissions and Health Authority correspondence familiarity (strongly preferred).

Responsibilities

• Create and maintain electronic project folders.
• Upload, track, and maintain life cycle of regulatory submissions (INDs, BLAs, CTAs) for US and ex-US regions in Veeva RIM.
• Maintain Veeva RIM by uploading submissions, Health Authority correspondence, etc.
• Track regulatory meetings, questions, information requests, and responses; ensure proper linking in Veeva RIM.
• Upload/manage Word and source documents in Veeva Vault for collaboration, version control, and updates.
• Capture and file regulatory documents received via email, secure links, or external portals in addition to gateway submissions.
• Assist with internal audits, Health Authority inspections, and regulatory inquiries related to RIM documentation.
• Organize and maintain working files, forms, sign-out sheets, and archives per SOPs and Health Authority requirements.
• Configure Vault objects, lifecycles, workflows, document types, and metadata.
• Provide technical/functional support for Veeva RIM user access.
• Assist with system validation, upgrades, and testing (GxP and regulatory standards).
• Partner with Regulatory Affairs, IT, and clinical teams to translate business requirements into technical solutions.
• Train Regulatory Documentation Specialists; provide post-training support.
• Serve as operational contact for Regulatory Affairs regarding Veeva RIM; provide day-to-day user support.
• Support upgrades/new software/removal of unused programs; perform ad-hoc cross-functional duties.

Skills

Regulatory operations

Veeva RIM

Veeva Vault

Documentation management

Project organization

Education

Bachelor’s degree in life sciences/technical discipline

High School diploma (with 9+ years experience)

Tools

Veeva RIM

Veeva Vault

Electronic Document Management Systems

Job description

Position Summary

The Veeva RIM Specialist provides expertise in the management and publishing of regulatory documents to ensure conformance with Health Authority requirements. Hands-on execution supporting US and ex-US regulatory activities and maintaining an inspection-ready system. Assists with submission and document management activities using Veeva RIM.

Essential Functions

• Create and maintain electronic project folders.
• Upload, track, and maintain life cycle of regulatory submissions (INDs, BLAs, CTAs) for US and ex-US regions in Veeva RIM.
• Maintain Veeva RIM by uploading submissions, Health Authority correspondence, etc.
• Track regulatory meetings, questions, information requests, and responses; ensure proper linking in Veeva RIM.
• Upload/manage Word and source documents in Veeva Vault for collaboration, version control, and updates.
• Capture and file regulatory documents received via email, secure links, or external portals in addition to gateway submissions.
• Assist with internal audits, Health Authority inspections, and regulatory inquiries related to RIM documentation.
• Organize and maintain working files, forms, sign-out sheets, and archives per SOPs and Health Authority requirements.
• Configure Vault objects, lifecycles, workflows, document types, and metadata.
• Provide technical/functional support for Veeva RIM user access.
• Assist with system validation, upgrades, and testing (GxP and regulatory standards).
• Partner with Regulatory Affairs, IT, and clinical teams to translate business requirements into technical solutions.
• Train Regulatory Documentation Specialists; provide post-training support.
• Serve as operational contact for Regulatory Affairs regarding Veeva RIM; provide day-to-day user support.
• Support upgrades/new software/removal of unused programs; perform ad-hoc cross-functional duties.

Education & Experience

• Bachelor’s in life sciences/technical discipline with 5+ years regulatory operations experience in biotech/pharma OR High School diploma with 9+ years.
• Hands-on experience with Veeva RIM and Veeva Vault.
• Global regulatory submissions and Health Authority correspondence familiarity (strongly preferred).

Knowledge, Skills & Abilities

• Expert knowledge of Health Authority procedures for document management/electronic submissions.
• Expert knowledge of Electronic Document Management Systems.
• Strong knowledge of Veeva Vault, especially Veeva RIM.
• Ability to meet deadlines and adapt to changing priorities.
• Strong organizational skills, written/oral communication, and attention to detail.