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

As the Principal Technical Writer, you will operate at the highest level in the technical writing series, providing strategic leadership and definitive regulatory guidance for all documentation projects. Your responsibilities will include leading, managing, and mentoring other technical writers, overseeing advanced and complex project activities for the implementation of product information, and ensuring the writing, editing, and publishing of critical documentation, including Instructions for Use. 

You will lead and provide guidance to cross-functional teams, operating autonomously to define work scope and execute tasks with minimal supervision. This role requires exceptional prioritization and communication skills to plan, estimate, and manage schedules, ensuring on-time delivery across multiple complex projects. A key component of the position is serving as the primary departmental resource for ensuring content quality and strict adherence to global regulatory requirements.

The Opportunity

People Leadership

• Supervise direct reports, serving as a direct supervisor to team members.

• You will coach and mentor team members, supporting their professional growth and career development.

• Facilitate collaboration. You'll foster a positive and inclusive team environment, ensuring a high level of communication and collaboration.

• Oversee performance management. This includes setting clear goals, conducting regular performance reviews, and providing constructive feedback.

• Contribute to hiring. You'll play a key role in the recruitment and onboarding of new technical writers, helping to grow our team.

Drives Quality and Regulatory Compliance

• Designs, develops, tests, and maintains documentation while ensuring that quality targets, timelines, and regulatory requirements are met.

• Develops and revises Quality System documents, such as Guidance Documents, Work Instructions, SOPs, and Templates, to drive consistency and quality of content in product information documentation.

• Maintains quality system compliance (e.g., follows processes and procedures as written).

• Supports the company for all Quality System Regulations related to labeling in internal and external body audits.

• Coordinates larger documentation tasks involving other internal or external technical writers.

• Acts as a consultant concerning tools, workflows, and templates applied within the documentation process.

• Manages translation activities with external agencies and oversees the translation review process with affiliates.

Who You Are

• You have a Bachelor's Degree in a scientific discipline, business administration, technical writing, or other related technical field. Equivalent combination of education and experience relevant to technical writing in the software or hardware industry may be substituted for the bachelor's degree.

• You have 4 years of demonstrating expertise in technical writing and documentation.

• You have 2 years demonstrating increased leadership competencies. 

• Knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDR and 21 CFR Part - 11), and control of electronic records is required.

Preferred Industry Knowledge:

• Knowledge of medical device, software, pharmaceutical, or biotechnology industry preferred.

• Experience with content management system deployment preferred.

Knowledge, Skills and Abilities

• Expert Technical Acumen: Strong communication and analytical skills, with strong technical acumen.

• Regulatory Knowledge: Knowledge of technical publications activities and requirements, change control, and configuration management. Speci