Job Description

Job 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.

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.

Education/Experience:

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

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