Senior Technical Writer
United States of America – Home Based
In this role, you have the opportunity to
Technical Writing providing labeling and label support for new product and sustaining efforts in Advanced Innovations (AI), Healthy Sleep Solutions (HSS), and Patient Interface (PI). Member of the core development team and responsible for all aspects of strategic planning for labels and labeling (both printed and electronic) including but not limited to: content, symbols, international standards compliance, translations, and approvals.
You are responsible for
- Maintain technical proficiency in core job functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements. Acts as a Mentor/Trainer for Associate Technical Writers
- Sits on New Product Development Team for assigned products and provides labeling analysis on the Product Development Plan Creation and execution of Labeling Plans for assigned products in the Domestic, Mature, and Emerging Markets, including released Labeling lists to support regulatory restrictions.
- Creation, revision, review, and approval of Labeling (User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels, Help Files, etc.)
- Supports Internal and External Quality Audits Actively supports CAPA’s as they apply to Labeling Leads Labeling Process Improvement efforts / Hoshins Partners with Translation Coordinator(s) throughout the execution of the associated Labeling plans.
- Interfaces with Business Unit functions as needed to resolve labeling concerns Tracks the impact of pending domestic and global regulatory changes on labeling.
- Conducts department training on labeling requirements
- Maintains proficiency in domestic and foreign regulations and standards, with a focus on labeling for assigned products and global impact.
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- Works as Technical Writer on problems of diverse scope where analysis of technical product data requires evaluation of identifiable factors.
- Mastery of page layout, word processing, and computer-generated illustrating using the following tools:
- The development of the solution requires a multi-disciplinary approach and knowledge of product data writing principles, -theories and -concepts.
- Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired knowledge.
- May lead multi-disciplinary change projects, managing a number of people. Works independently and provides consultative advice within specific functional areas.
- Introduces methods/procedures that are new for the organization.
- Applies advanced process principles to multiple tasks.
- Proficient in area of specialization and contributes in other disciplines. Determines feasibility of concepts or projects. Has basic knowledge of related disciplines.
- Bachelor’s degree with a minimum of 8 years of related experience in product writing.
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.