San Jose Metro Area, CA
Works closely with internal and/ or global partners to write, edit, and publish IVD laboratory requirements for internal and/ or customer facing documentation. Partner with Life Cycle teams to work on and complete existing and new documentation projects. Assists in the planning and completion of improvements to documentation and writing processes. Assists in the coordination and maintenance of corporate standards as they pertain to documentation.
The Technical Writer is first in the series of two jobs. The employee collaborates with cross functional teams to create and maintain technical documentation for IVD lab processes in accordance with the prescribed documentation standards and compliance requirements.
- Provides editing/ writing to technical teams as needed for IVD laboratory process and procedures.
- 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
- IVD laboratory requirements within established schedule and budget targets.
- Creates, writes and edits high quality text using corporate and department style guidelines.
- Reviews submitted documents to verify references, grammar and formatting.
- Verifies proper templates and revisions were used.
- Uses desktop publishing tools skillfully to produce efficient and accurate documentation.
- Manages project workspaces and workflows within the EDMS system.
- Interacts with interdepartmental teams to create, review and approve documentation.
- Manages the approval process to ensure the timely release of documentation.
- Provides guidance and direction to technical teams as needed.
- Develops and revises Quality System documents, such Guidance Documents, Work Instructions, and Templates to drive consistency and quality of content in user documentation.
- Communicates effectively with interdepartmental teams and external vendors/customers during activities such as the production and process of translation. Maintains departmental tools, processes and libraries.
- Assists with activities required for maintenance and publication.
- Assists in improving existing documentation practices.
- Trains and mentors other technical writer staff.
- Follows the Quality System Regulations and participates in audits as needed.
- Bachelors degree in a scientific discipline or business administration or other related technical field.
- Minimum of 5 years direct technical writing experience in medical device/ hardware and IVD laboratory operation procedures.
- 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.
- Experience in medical device software, and pharmaceutical/biotechnology industry.
- Demonstrable record of working on project teams while working on multiple projects.
- Experience with creating task oriented documentation.
Knowledge, Skills, and Abilities:
- Knowledge of technical publications activities and requirements, change control and configuration management.
- Excellent skills in communication, negotiation, motivation and persuasion required.
- Excellent technical writing skills and knowledge of desktop publishing applications, such as Adobe FrameMaker.
- Experience with graphics and using graphic design applications a plus.
- Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter.
- Ability to work with cross-departmental teams.
- Ability to manage projects and knowledge of project management concepts and principles.