Technical Writer / Sr Technical Writer - Personalized Healthcare Solutions (PHCS)

F. Hoffmann-La Roche Gruppe; Tucson (AZ); Remote; USD 53,000 - 100,000; Full time

Job summary

Roche is seeking a detail-oriented Technical Writer to ensure clarity and precision in documentation. This remote-based position involves oversight of documentation processes for Ventana Medical Systems products, including compliance with US and international regulations. Candidates should have a Bachelor's degree, extensive experience in the relevant industry, and strong technical writing skills. This role offers a competitive salary based on location and qualifications.

Qualifications

• 5 years in medical device, software, pharmaceutical, or biotech documentation.
• Knowledge of FDA, ISO, and 21 CFR 11 regulations.
• Experience with international regulatory requirements preferred.

Responsibilities

• Ensure precision in documentation for Ventana Medical Systems products.
• Manage project schedules and communicate with interdepartmental teams.
• Support quality system compliance and maintain corporate standards.

Skills

Technical writing skills

Desktop publishing

Communication

Education

Bachelor's Degree in a scientific discipline or business administration

Master's Degree (preferred for Senior Technical Writer)

Tools

Word processors

Spreadsheets

Project management tools

Electronic document management software

Job 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

Are you a detail-oriented professional who thrives in collaborative environments? As a Technical Writer, you'll be part of project teams, ensuring precision and clarity in documentation and labeling for Ventana Medical Systems products. Your role will include attending key meetings, managing project schedules, and keeping our Technical Documentation Department Supervisor informed. Beyond writing, you will be integral in the creation, review, revision, approval, and publication processes, while also assisting in upholding our corporate standards and maintaining our certificate library.

The Opportunity

• Providing guidance and direction to technical teams, while facilitating project activities and internal customer support.
• Serving as the primary interface between project teams and the Technical Documentation Department, acting as liaison to the project leader, conducting formal meetings, tracking project status, and resolving communication barriers.
• Facilitating the timely development, change, review, approval, and publication of documentation according to project schedules, including resolving resource issues related to processing documentation.
• Designing, developing, testing, and maintaining high-quality documentation for Ventana Medical Systems products associated with their design, manufacture, testing, release, installation, and distribution within established schedule and budget targets.
• Using desktop publishing tools skillfully to create, write, edit, and produce efficient and accurate documentation, maintaining departmental tools, processes, and libraries.
• Communicating effectively with interdepartmental teams and external vendors/customers, assisting in the publication, preparation, storage, and delivery of documentation.
• Supporting the maintenance of translated documents, updates, corporate standards, and certificate library management activities, while ensuring quality system compliance.
• Analyzing and improving existing documentation practices, maintaining performance metrics, supporting Quality System Regulations during audits, and performing other duties as assigned by management.

This is a remote-based role

Additional responsibilities for Senior Technical Writer

• Evaluating, recommending, and mobilizing the organization to adopt new component content management systems (CCMS) and business models.
• Developing and revising Quality System documents, such as Guidance Documents, Work Instructions, and Templates to drive consistency and quality of content in user documentation.
• Training and mentoring technical writers.
• Directing and providing oversight in managing the Bids and Quotes processing for translation operations, including continuous process improvement and the establishment of process metrics.
• Monitoring work to ensure quality, and continuously promoting Quality First Time.

Who You Are

Technical Writer

• Bachelor's Degree in a scientific discipline or business administration or other related technical field, required.
• 5 years of direct documentation experience in the medical device, software, pharmaceutical, or biotechnology industry.
• Authoritative knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR 11), and control of electronic records.
• Demonstrable record of working on project teams while working on multiple projects.
• Experience with international regulatory requirements preferred.

Senior Technical Writer

• Bachelor's Degree in a scientific discipline or business administration or other related technical field, required. Master's Degree is preferred.
• 8 years of direct documentation experience in the medical device, software, pharmaceutical, or biotechnology industry.
• Knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR 11), and control of electronic records.
• Experience with international regulatory requirements is preferred

Behaviors, competencies, and qualities of the ideal applicant.

• Specific job knowledge of Technical Publications activities, requirements, change control, and configuration management.
• Technical writing skills and knowledge of desktop publishing and online help. Quality orientation.
• Experience in illustrating, graphics, and screen capture is a plus.
• Demonstrates a high degree of initiative, motivation, and ability to work independently as a self-starter, as well as the ability to work with cross-departmental teams and all levels of employees. Strong process and business judgment. Able to plan and organize work while remaining flexible. Capable of preparing and presenting information clearly and concisely to groups.
• Proficient in word processors, spreadsheets, project management tools, and electronic document management software.

Relocation benefits are not offered for this job posting.

The expected salary range for the Technical Writer position, based on the primary location of Tucson, Arizona, is $53,400 - $99,200 annually.

The expected salary range for the Senior Technical Writer position, based on the primary location of Tucson, Arizona, is $63,100 - $117,300 annually.

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.