Engineering – Technical Writer

Planet Pharma Group; Lafayette (CO); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Planet Pharma in Colorado is seeking a Technical Writer to support the CST Technical Communication team. The role focuses on authoring and revising IFUs and eIFU content in structured XML (DITA-like), managing content through the CMS and quality system publishing pipelines, and supporting translation workflows.

You will collaborate with R&D, Regulatory, Quality, and software packaging/testing to deliver documentation on project timelines.

Competenze

• Bachelor’s degree in a related field and 5+ years of technical writing experience.
• Experience with structured authoring and CMS-based content management.
• Knowledge of medical device documentation regulations and quality systems.

Mansioni

• Create and edit IFUs and eIFU content in XML and publish via CMS.
• Collaborate with R&D, Regulatory, Quality and software packaging/testing.
• Ensure documents meet QA standards and project timelines.

Conoscenze

Structured authoring

IFU development

Quality system processes

Formazione

Bachelor's degree

Strumenti

CMS

XML authoring

Descrizione del lavoro

Technical Writer supporting the CST Technical Communication team. Day-to-day work includes authoring and revising Instructions for Use (IFUs) and eIFU content in structured XML (DITA-like), managing content through the CMS and quality system publishing pipeline, performing IFU change effect analysis, supporting translation/localization review workflows, and coordinating with cross-functional partners (R&D, Regulatory, Quality, and software packaging/testing) to deliver documentation on project timelines. The role supports active medical device delivery and release work under regulatory oversight.

Top 3 technical skills that are required for the role:

• 1. Structured authoring (Structured FrameMaker, Oxygen, or comparable), including CMS-based content management
• 2. Medical device IFU development (regulated industry experience for technical communications)
• 3. Quality system processes (change effect analysis, requirements traceability, translation workflows)

Education Required: Bachelor’s

Years' Experience Required: 5+ yrs

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, webbased 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 webbased 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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

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, gain input, and support decisionmaking.

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 University Degree and minimum of 2 years of relevant experience, or advanced degree