Pharma Documentation Specialist & Technical Writer (On-site)

MMR CONSULTING; Oceanside (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

MMR Consulting, an engineering and consulting firm serving the pharmaceutical and biotechnology industries, seeks a technical writer for on-site Oceanside, CA. The candidate will work with engineers and SMEs to develop, edit and validate documents for operational readiness, ensuring GDP compliance and templated consistency.

Requirements include a BA/BS in a related field, 3+ years of regulatory/document experience within biotech/pharma, and proficiency in Veeva QualityDocs and Google tools.

Qualifications

• BA or BS in English, Biology, Chemistry, Pharmacy, Engineering or equivalent experience.
• 3+ years creating/updating documents in a technical or regulatory environment; biotech/pharma preferred.
• Advanced word processing proficiency and wide range of technical skills including Google software.
• Experience with Veeva QualityDocs, Veeva OneQMS and collaboration systems.

Responsibilities

• Work with subject matter experts to create/edit/maintain documents for Operational readiness activities.
• Create and edit content using Veeva QualityDocs and ensure GDP compliance.
• Review content for site standards in formatting, organization and terminology.
• Solve complex technical writing issues following cGMP regulations.
• Initiate and execute Veeva Planned Events and track changes.
• Navigate company documentation system across Manufacturing, Facilities/Utilities and other functions.
• Set up and maintain tracking tools and metrics; communicate status of changes.
• Facilitate cross-site discussions/ meetings/adjudications.
• Adapt documents from other sites to Oceanside OSUT templates; on-site work required.

Skills

Technical writing

Attention to detail

Strong communication

Education

BA/BS in English, Biology, Chemistry, Pharmacy, Engineering or equivalent

Tools

Veeva QualityDocs

Veeva OneQMS

Google Workspace

SmartSheets

Trello

Job description

MMR Consulting, an engineering and consulting firm serving the pharmaceutical and biotechnology industries, seeks a technical writer for on-site Oceanside, CA. The candidate will work with engineers and SMEs to develop, edit and validate documents for operational readiness, ensuring GDP compliance and templated consistency.

Requirements include a BA/BS in a related field, 3+ years of regulatory/document experience within biotech/pharma, and proficiency in Veeva QualityDocs and Google tools.