Duration: 3 months – 10 hours a week
A Black Diamond client is looking for a Quality/Operations consultant who has a strong technical writing background to assist with creating policies and SOPs. They have two drugs in Phase 1 clinical trials and will be moving to phase 2 and 3 in 2021. They want someone to do a GAP analysis of their policies and SOPs to assess what they have and what is missing.
Some of the policies that need to be addressed include: Training, Part 11, CSV/IT, Compliance and Risk, Fraud, Archive/Storage, Security, Transparency and Disclosure, Scientific Publications, Pharmacovigilance/Safety Issues and Reporting, Business Continuity, Copyright and Medical Information Inquiries.
List of SOPs include Management and Conduct of pre-clinical GLP studies, For cause Audits, Good Documentation and Testing Practices for GxP, Regulated Computerized Systems, Data Transfer, Recall, Data Management and Statistics, Labelling, Evaluation & approval of contract testing laboratory, Handling of Artwork, Annual Product Quality Review, Preparation and review of site master file, Technology transfer, Creation, Control, Revision, Access, and archival of electronic documents, and Validation and verification of the analytical method.
- They will be moving to Phase 2 and 3 next year and want someone who has experience writing for biotech/pharma companies who have first products in these phases.
- Must have a strong technical writing background with quality and/or operations background for pharma/bio companies (prefer start ups).
- Must have experience scaling the phases and the work that needs to be done.
- Experience with clinical setting from pharma or bio perspective, phase 2 and 3 going through to commercialization.
- Experience more important than degree.
JOB ID# 227166