Roche
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.
People Leadership
Supervise direct reports, serving as a direct supervisor to team members
Coach and mentor team members, supporting their professional growth and career development
Facilitate collaboration. Foster a positive and inclusive team environment, ensuring a high level of communication and collaboration
Oversee performance management, including setting clear goals, conducting regular performance reviews, and providing constructive feedback
Contribute to hiring. Play a key role in the recruitment and onboarding of new technical writers, helping to grow the 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.
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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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.
People Leadership
Supervise direct reports, serving as a direct supervisor to team members
Coach and mentor team members, supporting their professional growth and career development
Facilitate collaboration. Foster a positive and inclusive team environment, ensuring a high level of communication and collaboration
Oversee performance management, including setting clear goals, conducting regular performance reviews, and providing constructive feedback
Contribute to hiring. Play a key role in the recruitment and onboarding of new technical writers, helping to grow the 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.
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