Global Regulatory Submissions Publisher

United States Digital Space LLC; United States; Remote; USD 62,000 - 94,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company contributions

Tuition reimbursement

Job summary

United States Digital Space LLC is seeking a Publishing Specialist within the Regulatory Submissions Management team to provide regulatory submission publishing services in a timely manner and ensure right-first-time submission quality. You will be a key point of contact for customers of the Regulatory Operations group and support the company’s regulatory strategies.

The role involves using Veeva for registrations, coordinating with Regulatory Affairs and affiliates, and working with global

Qualifications

• 1+ year of Submission Publishing and Submission Management principles preferred.
• Some hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault) an advantage.

Responsibilities

• Use Veeva for Registrations to plan and track submissions and manage own workload.
• Liaise with Regulatory Affairs and local affiliates to provide Submission Management and publishing support.
• Collaborate with regional Submission Publishing counterparts to facilitate global work-sharing.
• Provide customers with best-practice guidance within Submission Publishing and document standards.
• Support projects to improve publishing tools, standards, and processes.
• Monitor agency guidance and changing regulations in the assigned region.

Skills

Submission Publishing

Veeva Vault

PDF manipulation

Document Management

Tools

Veeva Vault

PDF manipulation software

Job description

United States Digital Space LLC is seeking a Publishing Specialist within the Regulatory Submissions Management team to provide regulatory submission publishing services in a timely manner and ensure right-first-time submission quality. You will be a key point of contact for customers of the Regulatory Operations group and support the company’s regulatory strategies.

The role involves using Veeva for registrations, coordinating with Regulatory Affairs and affiliates, and working with global