Senior Technical Writer (Remote)

About the role

The Senior Technical Writer will independently lead technical documentation and labeling activities for new product development and sustaining projects. They will partner with cross-functional teams to develop compliant, high-quality labeling and technical documentation while driving project execution, process improvement, and labeling strategy.

Responsibilities

• Lead technical documentation and labeling deliverables for new product development, sustaining, quality, regulatory, and business integration initiatives.
• Develop and maintain compliant labeling solutions in accordance with regulatory requirements and quality system procedures.
• Manage labeling requirements and content across labeling systems, authoring manuals and technical documentation, and partnering with label designers to ensure accurate and compliant execution of product labels.
• Partner with cross-functional teams to define documentation strategies and deliver high-quality labeling solutions that support business objectives.
• Drive documentation and labeling activities through all phases of the product lifecycle, balancing quality, compliance, schedule, and business needs.
• Perform labeling and documentation assessments to support new product launches, product changes, quality initiatives, and regulatory compliance activities.
• Contribute to engineering change requests, product transfers, remediations, NC/CAPA, and continuous improvement initiatives involving technical documentation and labeling.
• Utilize content management systems, structured authoring principles, and documentation best practices to improve efficiency, consistency, and scalability.
• Identify risks, resolve issues, and proactively drive projects and assignments to successful completion.

Requirements

• Bachelor’s degree in Technical Writing, Communications, or related field
• Minimum of 2+ years of experience in technical writing within the medical device industry
• Proficiency in DITA XML authoring and structured content development within content management systems
• Preferred: Experience utilizing technical documentation platforms and product lifecycle management (PLM) tools, such as Arbortext and Windchill
• Understanding of translation workflows and global documentation standards for regulatory compliance
• Experience working in cross-functional project teams, partnering with subject matter experts (SMEs) to gather, analyze, and incorporate technical requirements and input

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.