Remote Senior Associate Regulatory Affairs Operations (Publisher)

Planet Pharma; Illinois; Hybrid; USD 76,000 - 83,000; Full time

Job summary

Planet Pharma is seeking a document-control specialist to manage submission readiness, publishing, validation and QC review, ensuring accurate formatting and template usage for US submissions.

You will archive and retrieve records, support inspections, and assist with global IT tools like Smartsheet, Veeva, and eCTD 4. Hybrid or on-site work in Illinois may apply.

Qualifications

• Submission readiness, publishing, validation, and QC review.
• Document formatting and template creation.
• Hyperlinking and hyperlink management across documents.
• Supports development and implementation of global IT tools (Smartsheet, Veeva, eCTD 4).

Responsibilities

• Submission readiness, publishing, validation, QC review, and document formatting (45%).
• Archiving/closeout of submission sequences (20%).
• Archives HA correspondence and related docs in US archive and EDMS (15%).
• Supports document retrieval and inspections re: document requests as needed (5%).
• Creation and maintenance of SPL for Drug Establishment, Drug Listing, PI (HL7) (5%).
• Delivery of metrics and reporting compliance (5%).
• Support development and implementation of global IT tools (Smartsheet, Veeva, eCTD 4) (5%).

Skills

Submission readiness

Publishing

Validation

QC review

Document formatting

Template creation

Hyperlinking

Tools

Smartsheet

Veeva

eCTD 4

Job description

Pay 55-60/h depending on experience

• Submission readiness, publishing, validation, QC review, document formatting, template creation, and hyperlinking (45%)
• Archiving/closeout of submission sequences (20%)
• Archives HA correspondence (including emails, letters, faxes, contact reports and OPDP submissions) in US archive and EDMS (15%)
• Supports document retrieval as requested (electronic and paper); Supports inspections re: document requests as needed (5%)
• Creation and maintenance of SPL for Drug Establishment, Drug Listing, PI (according to HL7 standards) (5%)
• Delivery of metrics and reporting compliance (5%)
• Support development and implementation of global IT tools (Smartsheet, Veeva, eCTD 4) (5%)