Technical Writer - Project Manager

Responsible for managing Combination Product Development Process (CPDP) project activities and deliverables: including but not limited to Feasibility, Design Implementation, Verification, Validation and Risk Management

Responsibilities

• Ensure all documentation required for the CPDP process such as the D&DP, TM, TDR, DHF, Control Documents, Regulatory Strategies, FEMAs, HF studies, Risk Management studies, etc. are completed on time and documented appropriately.


• Responsible for communication of project status including design reviews, stage gates, meeting minutes, and audit support.


• Author technical documents outlined within governing procedures or project scope and collaborate with project team members including but not limited to quality, regulatory, tech ops, engineering, manufacturing, and external partners to ensure technical accuracy and readability.

·        Bachelor’s Degree and 3+ years of technical writing and Project Management experience

·        Superior written and verbal communications skills

·        Excellent command of the English language and grammatical application thereof

·        Keen attention to detail

·        Highly organized

·        Proficient with MS Word, including TOC, creating/using styles, footnotes, and cross references

·        Competent with MS Excel, PowerPoint, and Outlook

·        Familiar with SharePoint and electronic document management systems

·        Able to multi-task and quickly adjust to changing priorities without sacrificing quality or timely completion of tasks