Roche
Scientific Technical Writer
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Scientific Technical Writer
role at
Roche . At Roche we encourage personal expression, open dialogue, and genuine connections, valuing every voice so that you can thrive both personally and professionally. Our mission is to prevent, stop and cure diseases and ensure everyone has access to healthcare now and for generations to come.
Position Overview We are part of the Product Information Operations (PIO) team focused on creating and optimizing product information for Core Lab and numerous Near Patient Care products. In close collaboration with Marketing, R&D, Regulatory Affairs and IT, we ensure timely delivery of product information that complies with all applicable government policies, procedures and regulations. We are advancing a digital transformation journey, improving systems and integrating machine translation and AI to increase efficiency. Join us to help shape the future of product information.
The Opportunity
Create or change Instructions for Use (e.g., Method Sheets and Notes) using our internal CMS.
Collect required data from stakeholders and prepare content considering legal regulations, regulatory requirements, technical conditions and internal guidelines.
Ensure product labeling is consistent across all forms and conforms to FDA, ISO, IVDD/IVDR, CE, and other global regulatory guidelines.
Coordinate the content approval process of document contents and activities up to the completion of the US-specific labeling.
Participate actively in planning completion deadlines and collaborate closely with relevant internal interfaces, e.g., Regulatory Affairs and Marketing.
Serve as a Subject Matter Expert in launch or change projects, contribute to method sheet generation, and advise the project team on specialized issues.
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
Prior experience in medical device, pharmaceutical or related industries is preferred.
Ability to work in a highly regulated and matrixed environment.
Knowledge of FDA regulations, quality system guidelines, ISO and other applicable regulations and standards.
Ability to work independently, creatively, and efficiently.
Experience with XML editing systems, particularly ST4.
Strong communication skills and a collaborative spirit.
Strong organizational and project management skills.
Relocation benefits are not available for this posting.
This is not a remote role. The role is at the Roche Indianapolis company site and supports a hybrid model of working both at work and home on a weekly basis.
The expected salary range for this position based on the primary location of Indianapolis, IN is $63,100 - $117,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits: We empower each other to explore new possibilities, foster creativity, and keep our ambitions high. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of protected veteran status, individuals with disabilities, and consistent with all federal, state, or local laws. 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. 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.
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Scientific Technical Writer
role at
Roche . At Roche we encourage personal expression, open dialogue, and genuine connections, valuing every voice so that you can thrive both personally and professionally. Our mission is to prevent, stop and cure diseases and ensure everyone has access to healthcare now and for generations to come.
Position Overview We are part of the Product Information Operations (PIO) team focused on creating and optimizing product information for Core Lab and numerous Near Patient Care products. In close collaboration with Marketing, R&D, Regulatory Affairs and IT, we ensure timely delivery of product information that complies with all applicable government policies, procedures and regulations. We are advancing a digital transformation journey, improving systems and integrating machine translation and AI to increase efficiency. Join us to help shape the future of product information.
The Opportunity
Create or change Instructions for Use (e.g., Method Sheets and Notes) using our internal CMS.
Collect required data from stakeholders and prepare content considering legal regulations, regulatory requirements, technical conditions and internal guidelines.
Ensure product labeling is consistent across all forms and conforms to FDA, ISO, IVDD/IVDR, CE, and other global regulatory guidelines.
Coordinate the content approval process of document contents and activities up to the completion of the US-specific labeling.
Participate actively in planning completion deadlines and collaborate closely with relevant internal interfaces, e.g., Regulatory Affairs and Marketing.
Serve as a Subject Matter Expert in launch or change projects, contribute to method sheet generation, and advise the project team on specialized issues.
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
Prior experience in medical device, pharmaceutical or related industries is preferred.
Ability to work in a highly regulated and matrixed environment.
Knowledge of FDA regulations, quality system guidelines, ISO and other applicable regulations and standards.
Ability to work independently, creatively, and efficiently.
Experience with XML editing systems, particularly ST4.
Strong communication skills and a collaborative spirit.
Strong organizational and project management skills.
Relocation benefits are not available for this posting.
This is not a remote role. The role is at the Roche Indianapolis company site and supports a hybrid model of working both at work and home on a weekly basis.
The expected salary range for this position based on the primary location of Indianapolis, IN is $63,100 - $117,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits: We empower each other to explore new possibilities, foster creativity, and keep our ambitions high. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of protected veteran status, individuals with disabilities, and consistent with all federal, state, or local laws. 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. 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.
#J-18808-Ljbffr