Technical Writer for Labeling Team

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. Specific job knowledge of Technical Publications activities and requirements, and change control.
- Leadership and Team Skills: Excellent team skills, organizational skills, and problem-solving skills. Excellent skills in communication, negotiation, motivation, and persuasion. Ability to work with cross-departmental teams and all levels of employees.
- Project Management: Ability to manage projects and general knowledge of project management concepts and principles and document management tools and systems.
- Writing Tools: Excellent knowledge of technical writing applications such as electronic content management systems.

Relocation assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Branchburg, NJ is 84,800.00 - 157,400.00 USD Annual. 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/u2019s 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.

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