Senior Technical Writer

Top Skills:

• Bachelor’s degree required - Life Sciences degree preferred
• Minimum of 1-3 years’ experience in a GMP environment.
• 1-3 years’ experience with GMP labelling is preferred.
• Experience with Oracle and/or SAP preferred.

Position Summary

The Technical Writer will manage and oversee data input and documentation management, and functions as detailed below to ensure delivery of Cell Therapy labelling projects.

Key Responsibilities and Major Duties

• Write and revise standard operating procedures (SOPs) and specifications for GMP Labelling operations
• Complete intake forms and follow up on item creation process with cross functional stakeholders.
• Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
• Schedule cross functional team meetings, collect feedback, create draft documents, schedule reviews, collect and resolve feedback.
• Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
• Prepare document periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
• Maintain a good understanding of regulations and other guidelines applicable to GMPs.

Requirements

• Minimum of 1-3 years’ experience in a GMP environment.
• 1-3 years’ experience with GMP labelling is a plus.
• Experience with Oracle and/or SAP a plus.
• Demonstrated ability to successfully manage competing deadlines and balance priorities.
• Ability to track and follow up on multiple workstreams and escalate when appropriate.
• Expertise in Microsoft Word.
• Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
• Bachelor’s degree required - Life Sciences degree preferred