• Job Description

  Req#: 202403-107681

  Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

  The Position

  A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

  Creating a world where we all have more time with the people we love.

  That’s what makes us Roche.

  Job Summary

  The Technical Writer will research, develop, write and edit technical and informational materials for various organizational needs and publications in one or more of the following areas: product labels; package inserts; instrument manuals; price lists; application sheets; customer bulletins and letters; online help text; instrument calibrator and parameter diskettes; or other electronic documentation for Roche products and/or other miscellaneous publications, both for internal and external customer usage. Collaborates and works with medical subject matter experts to obtain and ensure the accuracy of the medical content. Ensures that all materials meet established global and country standards as to appearance and content and ensures documents are in compliance with applicable government policies, procedures and regulations.

  Your Opportunity

  • Develop and/or maintain product labeling (for example: method sheets, application sheets,, addendums, bar sheets, labels, calibrator and parameter diskettes, application/calibrator bar sheets, value sheets, e-packages etc.) utilizing the department’s approved software. Ensures that product labeling is consistent across all forms, and conforms to the Food & Drug Administration (FDA), International Standards Organization (ISO), InVitro Device Directive/InVitro Device Requirements (IVDD/IVDR), European Union Conformity (CE), other global, regulatory, and legal guidelines.

  • Review Labeling Change Order (LCO) and Labeling Change Order Notice (LCON) for product labeling (Labels, Inserts, Addendums, Barcode Transfer Sheets (BTS) developed or modified by labeling colleagues. Coordinate content approval of globally developed labeling with required USA reviewers. Communicate US requirements and input on labeling back to labeling originator in a timely manner to prevent reworks of the product at Roche Indy. Negotiate with labeling originators to develop labeling content that is acceptable for the USA.

  • Interact with local and global counterparts in project planning, configuration management, quality, production planning, engineering, print and other service vendors, R&D, product managers, regulatory, legal, technical service, to identify errors/potential problem areas/clarify inconsistencies that could result in product backorders and/or incorrect information being distributed to customers and internal personnel.

  • Determine and coordinate content approval cycle for labeling

  • Maintain archival/backup files of all electronic and written documents per departmental AWIs; ensure that document retrieval protocol is followed.

  • Create and maintain labeling rework information

  Who You Are

  • Bachelor’s degree in Technical Writing, Medical Technology, Communications, Health Science or related field.

  • Five years of prior experience in technical writing, product labeling, technical publications or related experience.

  Knowledge, Skills & Preferences

  • Ability to work in a highly regulated and matrixed environment.

  • Working knowledge of FDA regulations, quality system guidelines, ISO and other applicable regulations and standards.

  • Ability to work independently, creatively, and efficiently.

  • Must have strong organizational and project management skills.

  • Seven years of prior experience in technical writing, product labeling, technical publications or related experience in a health care, scientific, or manufacturing environment is preferred.

  • Prior experience in medical device, pharmaceutical or related industries is preferred.

  Relocation Benefits are not eligible for this role

  Who we are

  At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

  If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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