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Technical Writer
Ref No.: 18-19468
Location: Santa Clara, California
JOB SUMMARY:
Works closely with internal and/ or global partners to write, edit, and publish Roche Sequencing Solutions (RSS) internal documentation. Partner with Life Cycle teams to work on and complete existing and new documentation projects.

DISTINGUISHING CHARACTERISTICS:
At this level, the employee additionally provides writing and documentation guidance to technical teams and participates in the planning, governance, and improvements to documentation and writing processes.

ESSENTIAL RESPONSIBILITIES:
  • Works closely with cross functional project teams and other technical writers for writing projects and conducts formal review meetings, tracks project status, and resolves any communication barriers
  • Facilitates the timely development, change, review and approval of documentation.
  • Designs, develops, tests, and maintains documentation for Roche Sequencing Solutions (RSS) within established schedule and budget targets.
  • Creates, writes and edits high quality text using corporate and department style guidelines.
  • Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
  • Participates on teams to drive organizational adoption of new tools and processes for content creation and management.
  • Develops and revises Quality System documents, such Guidance Documents, Work Instructions, and Templates to drive consistency and quality of content in user documentation.
  • In collaboration with engineering team, develops and revises Engineering documents, such Verification Plans, Test Cases, Test Reports, Work Instructions, and Templates to drive consistency and quality of content in documentation.
  • Communicates effectively with interdepartmental teams and external vendors/ customers during activities such as the design transfer and production.
  • Maintains established metrics to monitor department activities and performance measures.

MINIMUM QUALIFICATIONS:
Formal Training/Education:

Bachelor's degree in a scientific discipline, business administration, technical writing, or other related technical field required. Master's degree preferred.

Experience:
  • Minimum of 5 years' experience required.
  • The experience relates to 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 Part -11), and control of electronic records preferred.
  • Demonstrable record of working on project teams while working on multiple projects.
  • Experience with mentoring other technical writers preferred.
  • Knowledge of medical device, software, pharmaceutical, or biotechnology industry preferred