Description:
We are seeking a detail-oriented and experienced Technical Writer to support Cell Therapy labelling operations in a regulated GMP environment. The ideal candidate will have a background in life sciences or technical documentation, and experience managing documentation and label development using EDMS and ERP systems like Oracle or SAP.
Key Responsibilities
- Author, revise, and manage Standard Operating Procedures (SOPs) and specifications for GMP labelling.
- Complete intake forms and track item creation by coordinating with cross-functional teams.
- Conduct interviews with subject matter experts and translate their input into actionable documentation (e.g., Work Instructions, Job Aids).
- Schedule and facilitate meetings to gather feedback, draft documents, manage reviews, and drive approvals.
- Upload and manage documents using Electronic Document Management Systems (EDMS).
- Maintain a document periodic review calendar, ensuring timely completion of reviews and updates.
- Maintain up-to-date understanding of GMP regulations and ensure documentation is compliant.
Qualifications
Must-Haves:
- Bachelor’s degree required (Life Sciences preferred).
- 1–3 years of experience working in a GMP environment.
- Familiarity with GMP labelling requirements.
- Proficient in Microsoft Word, Outlook, Teams, SharePoint, and EDMS.
- Experience with Oracle and/or SAP systems.
- Strong organizational and communication skills.