Scientific Technical Writer at F. Hoffmann-La Roche Ltd - Poland

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

117300.0

Posted On

23 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, Product Labeling, Regulatory Compliance, FDA Regulations, ISO Standards, Project Management, Communication Skills, Medical Technology, Creative Problem Solving, Team Collaboration, Content Approval Process, XML Editing Systems, Organizational Skills, Health Science Knowledge, Method Sheets, Documentation

Industry

Biotechnology Research

Description

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 interfaces, e.g. Regulatory Affairs and Marketing take on the role of Subject Matter Expert in launch or change projects, contribute to the generation of corresponding method sheets, 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. You have the ability to work in a highly regulated and matrixed environment. You have knowledge of FDA regulations, quality system guidelines, ISO and other applicable regulations and standards. You show the ability to work independently, creatively, and efficiently. You have experience in the use of XML editing systems, particularly ST4 You have strong communication skills and enjoy working in a team You have strong organizational and project management skills Relocation benefits are not available for this posting This is not a remote role. This role is to work at the Roche Indianapolis company site. This role supports the 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 Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. 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 status, 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

As a technical writer, you will provide product information to customers in the US, ensuring timely creation of 'Instructions for Use' during product changes and launches. You will coordinate content approval processes and collaborate closely with internal teams to ensure compliance with regulatory requirements.