Organization: Siemens Healthineers
Business Unit: Diagnostics
Requisition Number: 246740
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 25%
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Job Title: Manager Molecular Product Labeling
This position will be responsible for managing the Molecular Diagnostics Product Labeling team, which is responsible for content development for product documentation, end-user instructions, operator’s manuals, and other labeling or documentation for Molecular Diagnostics products. This position reports into the VP of Quality and Technology for the Siemens Molecular Diagnostics business.
The Manager of Molecular Product Labeling ensures that all labeling requirements are met for new products and for existing product changes. The Manager will be responsible for a team that is responsible for the creation and maintenance of product labeling content. The Manager will work closely with Regulatory Affairs, Quality, and Product Development teams to ensure compliance to global product labeling requirements throughout the product life cycle. The manager acts as the Molecular Process Owner by continuously improving product labeling processes and updating the relevant SOPs. He/she facilitates communication among key stakeholders for country specific requirements in product labeling, and manages labeling content and language translations to support business growth. The applicant should be a strong leader and manager, and will develop resourcing strategies, allocate budgets, staff, tools and specialized support necessary for efficient operations. The successful candidate will develop innovative regulatory strategies to improve time to markets, proactively monitor global new or revised regulations, and implement actions to ensure completion of product labeling deliverables, while assuring that there are no significant interruptions to the business due to quality or compliance issues
This position requires someone with in-depth knowledge of technical writing or instructional design principles, tools, practices and procedures. Content deliverables may include product documentation, end-user instructions (IFUs and Product Inserts), Operator’s Manuals, online help and release notes. The manager may represent the Product Labeling function on project teams or cross-business projects.
•A Bachelor’s degree with 8+ years of experience or Master’s degree with 5+ years of experience preferably in areas of life sciences, engineering, or quality assurance. An advanced scientific degree or MBA is preferred.
• Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
• Proven leadership and managerial skills in order to build and sustain a vision for the work group.
• Working knowledge of Adobe FrameMaker, Adobe Acrobat, Adobe Illustrator, Adobe Photoshop, Microsoft Word and Microsoft PowerPoint and XML
• Excellent working knowledge of English grammar, punctuation and overall writing skills, editing
• Ability to effectively manage multiple tasks and resolve conflicts
• Ability to meet the challenges of aggressive deadlines, with flexible working hours to cover various time zones globally
• Demonstrated communication skills for managing and working on cross-functional teams
• Understands regulations and guidelines governing the areas of medical device and diagnostic development. Has broad knowledge of related topics such as Quality Assurance, Manufacturing and Development.
• Critical thinker able to address complex situations and issues. Acts decisively, holds position and challenges others appropriately.
• Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
• 5+ years’ experience managing people and/or leading a team of writers, graphic designers, and content developers preferred
• Prior medical device writing experience, medical package insert experience, complex hardware operation and service procedure experience or scientific writing experience preferred.
• Familiarity with international regulations for product labeling in both labeling content and language requirements for medical devices preferred.
• Prior experience in working with cross-functional project teams, suppliers, and business partners preferred.
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.