Technical Writer, Commercial Readiness (Contract)
We are looking for a Technical Writer that will support aspects of the on-going Commercial Readiness initiatives at our clients facility in Waltham.
Functions:
- Own and support quality and technical documentation for cross-functional teams at the Waltham facility
- Generate, revise, review and approve Standard Operating Procedures (SOPs), policies, and other documents to support commercialization efforts
- Recommend, support, and drive implementation of Operational Excellence and Commercial Readiness programs supporting efficiencies in execution and across our client’s facility in Waltham
- Support organization and delivery of technical and quality training teams, as applicable
- Support project team environment with project deliverables, ensuring critical milestones are successfully achieved
Requirements:
- Minimum Bachelor’s Degree in Engineering, Biology, Chemistry, or a related field
- At least 4 years of experience in a Manufacturing, Quality, or Regulatory role supporting both early phase and commercial cell therapy products.
- Experience working within a contract manufacturing or client service organization.
- Familiarity with manufacturing/quality architectures and systems (e.g. SAP, electronic batch records, Veeva)
- Demonstrated ability and strength in leading or supporting cross-functional teams
- Strong attention to detail supported by excellent time management and organizational skills
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