Scientific Technical Writer
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
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.
Our team in Product Information Operations (PIO) is focused on creating and optimizing product information for all Core Lab as well as numerous Near Patient Care products.
In close collaboration with our interfaces in Marketing, R&D, Regulatory Affairs and IT, we ensure that our customers receive the necessary information on time and all documentation is in compliance with applicable government policies, procedures and regulations.
We are in the midst of our journey towards digital transformation and process optimization and are looking for pioneers who want to shape the future with us.
We continuously improve our systems and integrate innovative technologies such as machine translation and artificial intelligence to make our processes more efficient.
Become part of our dynamic team and help shape the future of product information!
The Opportunity
As a technical writer you are key to providing product information to our customers in the US.
You ensure that the "Instructions for Use" for our products are created within the specified time and cost frame during product changes and launches of new products.
That includes content handling/modification and timely provision of method sheets and other labeling deliverables for the US.
Your area of responsibility includes, among other things, the following activities:
* independent creation or change of Instructions for Use (e.g.
Method Sheets and Notes) utilizing our internal CMS
* collection of the necessary data from the relevant stakeholders and preparation while considering legal regulations, regulatory requirements as well as technical conditions and internal guidelines
* ensure 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.
* coordination of the content approval process of document contents and activities up to the completion of the US-specific labeling
* active participation in planning completion deadlines and close collaboration with relevant internal interfa...
- Rate: Not Specified
- Location: Indianapolis, US-IN
- Type: Permanent
- Industry: Media
- Recruiter: 6019 Roche Diagnostics Operations, Inc.
- Contact: Recruiter Name
- Email: to view click here
- Reference: 202511-129539
- Posted: 2025-11-23 08:15:52 -
- View all Jobs from 6019 Roche Diagnostics Operations, Inc.
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