Job Description

Job Title: Technical Writer II

Location: Newark, DE
Duration: 12 months+ contract (Possible extension)

Job Description:

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. This individual combine multimedia knowledge and strong communication skills with technical expertise to educate across the entire spectrum of user abilities, technical experience and visual and auditory capabilities. They create and publish technical documentation and manuals and collect and interpret technical data or information and coordinate layout for publication. Produces products that conform to the company documentation and quality assurance standards.

The Technical Writer 3 works on problems of diverse Product where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. This individual is a seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Essential Duties and Responsibilities:

· The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

· 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.

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