Position Title: Technical Writer 3
Work Location: Newark, DE 19702
Assignment Duration: 5 months
Work Arrangement: Onsite

Position Summary:

• The Technical Writer 3 develops, designs and controls instructional and informational tools needed to assure safe, appropriate, and effective use of science and technology, intellectual property and manufactured products and services.

Key Responsibilities:

• Works closely with key personnel and participates in technical training to develop expert level understanding of assays, instrumentation, and software as it applies to documentation.

• Manages multiple user documentation projects at a time.

• Designs and implements work instructions, area guidelines, knowledge base topics, style guides/templates and departmental SOPS. Analyze current processes, identifying and evaluating options and suggesting changes with the intent of improving efficiency, or quality.

• Guides or performs the creation of new documentation and the review, revision and enhancement and approval of existing documentation. Identify and implement document changes to maintain consistency across product lines/processes.

• Performs and troubleshoots instrumentation, assays, software applications, etc. to develop and improve content.

• For INVs/CAPAs, conduct investigations using analytical skills and judgement, conferring with other writers and SMEs when appropriate, to determine root cause, and to recommend and implement changes.

• Supports core team members and project team leads in developing documentation timelines and deliverables.

• Attends project/core team meetings as required as extended core team representative and make recommendations regarding the IFU project schedule and deliverables required considering information learned at these meetings.

• When needed coordinates and manages translation projects. Work with translation vendors in managing translation development and procurement process. Responds to questions from the vendor with minimal help from management.

• Coordinates the collaborative review process and leads collaborative review sessions. Establish review and edit cycles based on the project timeline and availability of resources. Train cross-functional team on review process as needed.

• Coordinates the transition of documentation through preproduction, regulatory submission, and production phases as appropriate. Act as approver as needed.

• Uses discretion and judgement, including consideration of business priorities, to prioritize deliverables and manage “expedites.”

• Independently integrate SDS information into package inserts to comply with GHS standards.

• For inventoried items, prepare specs and work with procurement to ensure accuracy.

• Coordinates final production of documents w/ print vendors as required.

• As required, assign document change responsibilities, and provide training and assistance to EDMS users.

• Processes labeling project change orders in EDMS/Agile system.

• Initiates and drives departmental continuous improvement and implementation of best practices.

• Participates in professional development and works towards obtaining/maintain certification relevant to job functions.

• Works in conjunction with other departments where appropriate.

• Must follow all applicable FDA regulations and ISO requirements.

Qualification & Experience:

• Education: College Degree or Technical Bachelor’s Degree (preferred)

• Experience: 5–8 Years (or less with higher degrees)

• Experience with PLM systems

• Experience with source controls like Team Foundation Server, GitHub

• Skills: Adobe FrameMaker, MadCap Flare, InDesign, Author-IT, MS Office

• Knowledge of Agile, HTML, CSS is beneficial

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $35.00/hr.