Technical Writer responsible for the assessment, development and authoring of technical literature deliverables (Instructions for use, labeling).
The Technical Writer Products, revises and drafts a variety of patient-facing technical literature needed to support a broad medical device portfolio.
Technical writer will be responsible for executing project requirements in the creation of technical literature. Including the following:
Develop of a working understanding of medical device products
Work with required subject matter experts to align content changes
Author new literature in the Component Content Management System
Review literature to ensure compliance with all known requirements and departmental SOPs
Collaborate with graphic design team on layouts, drawings, images, and branding needs
Ensure all required approvals are obtained so literature can complete required technical review
Proactively identify gaps and work with team members to determine responses
Responsibilities may include the following and other duties may be assigned:
Creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web-based publications and user sites; may produce content for embedded user assistance technology.
Conducts interviews with various users and technical staff to gather data for documentation.
Researches and translates technical information into manuals and/or web-based documents for nontechnical and technical users.
May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.
Education Required/Requirements:
Bachelor’s degree Years’ Experience Required: 0-3 years (see education and experience requirements below).
Technical writing experience
Experience in a regulated environment preferred
Medical device and/or patient-facing documentation experience is a plus
Nice to have:
Experience writing in a highly regulated environment.
Experience writing patient-facing literature
Experience authoring in a Component Content Management System (CCMS)
Differentiating Factors Autonomy:
Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones.
May have some involvement in cross functional assignments.
Innovation and Complexity:
Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence:
Communicates primarily and frequently with internal contacts.
External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, Product input, and support decision-making.
Leadership and Talent Management:
May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. and 214.2(h)(4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.