ENGINEERING – TECHNICAL WRITER

Engineering – Technical Writer

Location: North Haven, CT

Category: Engineering

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Please confirm your top 3 skills sets required?

• Strong collaboration, verbal/written communication skills, and technical writing core competencies.
• Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).
• Experience in complex regulatory environments and robust quality processes.
  
  

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Update Instructions for Use to align with cross-functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.
• Support approvals in PLM tools, facilitate translations requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).
• Participate in project and team meetings and collaborate with teams to create, analyze, and finalize Instructions for Use from planning through launch.
  
  

What is your target years of experience? 5-10 years

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Responsibilities may include the following and other duties may be assigned.

• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
• Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.
• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
• Conducts interviews with various users and technical staff to gather data for documentation.
• Recommends formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs, and departmental and business-unit audits.
• Contribute to time and cost estimates for labeling deliverables for project teams.
• Develop illustrations in cooperation with professional illustrators.
• Participate on department and business-unit initiatives.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track the status of translations.
• Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.
  
  

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.