WE ARE HIRING! SEVERAL NEW OPPORTUNITIES!
Seeking contract technical writers for multiple projects:
- Biologics Manufacturing Batch Records and SOPs
- Market Authorization Transfer
- Technical Transfers
- Biologics Deviations and Investigations
- Annual Product Reviews
- Diagnostics Instrumentation User Documentation
Contract position providing technical writing support for GMP manufacturing and quality documentation.
Job responsibilities include:
• Create (from-scratch) and/or significantly rewrite documents may include batch records, SOPs, data forms, specifications, and logsheets.
• Master technical information, organize content, and imbed GMP compliance.
• Align documents within and across one another to prevent gaps, overlaps, and contradictions or conflicting instruction.
• Work independently, with minimal SME input, to draft documents and redlines.
• Meet deadlines.
• Contribute to training materials as required.
• Manage document review cycles, including solicitation of feedback, comment remediation, issue escalation and/or resolution, and finalization in copy-ready format.
• Schedule, lead, and facilitate document review meetings.
• Participate on project teams as needed.
• Expeditiously and accurately process large volumes of documents, with short turnaround and high quality and accuracy.
• Understand how GMP documents fit together and can independently manage document dependencies.
• BS/BA and at least 8 years pharmaceutical industry experience, 5+ years in technical writing role preferred.
• Experience with consent decree, quality remediation in the small molecule and biologics areas big plus for more senior opportunities.
• Impeccable attention to detail.
• Ability to manage shifting priorities and fast pace.
• Strong written and verbal communication skills.
• Fast and agile in MS Word, Excel, and Visio
• Comfortable leading and influencing without authority.
• Comfortable holding project team members and senior management accountable to support documentation objectives.
• Ideal candidate has hands-on manufacturing, engineering, QC and/or QA experience (depending on role) and can speak intelligently on documentation related issues.
• Travel may be required, depending on project.
Check out additional project openings at: www.bulletproofdocs.com/opportunities