Technical Writer 2 Job at SGS Consulting, Delaware, OH

U1UvV0o0am92V242TEtvN3JlQmVzN05LQ1E9PQ==
  • SGS Consulting
  • Delaware, OH

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.

Job Tags

Similar Jobs

Keeper.app

Founding Sales Recruiter Job at Keeper.app

 ...What youll do Your job is to find, qualify, and attract top talent to join our Sales team. This role will report to the Sales Manager. Key Responsibilities: As the Founding Recruiter in Sales, you will help us streamline our hiring processes as we implement our... 

Hasbro

Specialist Customer Marketing, Mat Cover Job at Hasbro

 ...in Europe and the Middle East and Africa. Specialist Customer Marketing - MAT Cover The Specialist Customer Marketing role is a key enabler...  ...in English required; additional European languages (French, Spanish, Italian, German) are a plus. Leadership Principles - To Play to... 

VDart Inc

SAP Security Consultant Job at VDart Inc

 ...Role: SAP Security Consultant Location: Raleigh, NC (Onsite) Duration: Contract Job Description: SAP HANA Security experience SAP S/4 HANA implementation and support User and role management in SAP HANA Configuration and customization... 

Ansible Government Solutions

Ambulatory Care Outpatient Registered Nurse (RN) Job at Ansible Government Solutions

 ...Overview Ansible Government Solutions, LLC (Ansible) is currently recruiting multiple Ambulatory Care Outpatient Registered Nurses to support the Castle Point VA Medical Center located at 41 Castle Point Rd, Wappingers Fall, NY 12590. Nurses may also be asked to provide... 

Clayton County Public Schools

School Secretary I Job at Clayton County Public Schools

School Secretary I Location Riverdale, GA : Applicants: Please ensure that you upload all necessary documents and include all relevant...  ...: Performs a full range of office assistant/receptionist duties; answers telephone/greets visitors, makes appointments,...