Scientific Content Developer
4 weeks ago
Job Title: Contract Documentation Specialist/Scientific Writer
Duration: 12 Months
Location: MA-Worcester (100 Research Drive)
Job Summary:
The Contract Documentation Specialist/Scientific Writer will work closely with Purification group leaders and Subject Matter Experts to draft, format, and complete technical documents required for the development and characterization of biological molecules.
Key Responsibilities:
• Develop and prepare high-quality technical documents, including Process Development Reports, Process Characterization/Validation Study Protocols and Reports, and Risk Assessments Reports.
• Collaborate with the Purification development and CMC Project management teams to document process risk, characterization, control, and validation matrix.
• Provide editorial support to ensure the quality of all scientific content, focusing on clarity, accuracy, and consistency while adhering to proper formatting and regulatory requirements.
• Initiate and oversee multiple rounds of document review and subsequent revisions by proactively interacting with Purification SMEs.
• Perform data integrity review, process documentation gap analyses, and update platform documents for report requirements.
• Contribute to the overall success of the organization by ensuring the timely completion of documents required for project progression and other regulatory supporting documents.
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