Technical Writer

Description

Must be onsite

Job 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.
• This individual combines 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 scope 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:

• 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.

Physical Demands:

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Safety Shoes with Impact and Compression Protection Must be worn in designated areas.
• Exposure to blood.
• Travel (please specify):
• Other (please specify):

Qualifications:

Education

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree

Experience

• Preferred Minimum Non-Technical Degree: 5-8 Years
• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD
• Experience with PLM systems
• Experience with source controls such as Team Foundation Server and GitHub is beneficial.

Skills

• In depth knowledge of Technical Writing Theory and Practices, Design Theory
• Proficiency in Adobe FrameMaker, MadCap Flare, InDesign, Author-IT and MS Office applications
• Project and time management skills
• Analytical, problem-solving, and troubleshooting skills
• Interpersonal skills
• Exceptional written and verbal communication skills.
• Adapts communication style to different audiences.
• Creates precise, accurate technical documentation.
• Able to facilitate group discussions.
• Knowledge of Agile, HTML or CSS is beneficial.