The primary responsibility of this position is to act as the Technical Writer on project teams, attend meetings, maintain project schedule and update the Supervisor of the Technical Documentation Department. Involved in the creation, review, revision and approval and publication of documentation and labeling for all client products. Assists in the coordination and maintenance of corporate standards and certificate library management activities.
- Facilitates project activities and internal customer support.
- Provides guidance and direction to technical teams as needed.
- Serves as a primary interface between project teams and Technical Documentation Department, acts as liaison to project leader, conducts formal meetings, track project status and resolves any communication barriers.
- Facilitates the timely development, change, review and approval of documentation according to project schedules, including the resolution of resource issues relative
- to processing of such documentation.
- Designs, develops, tests, and maintains documentation for client products associated with the design, manufacture, test, release, installation, and distribution within established -schedule and budget targets.
- Creates, writes and edits high quality text and graphics, using easy-to-understand grammar, excellent writing structure and good punctuation.
- Uses desktop publishing tools skillfully to produce efficient and accurate documentation.
- Communicates affectively with interdepartmental teams and external vendors/customers.
- Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
- Assists in the maintenance of translated documents, updates and storage as required.
- Maintains departmental tools, processes and libraries.
- Helps maintain all desktop publishing tools that are required to skillfully produce efficient and accurate labeling documentation.
- Assists in the maintenance of corporate standards and certificate library management activities.
- Maintains quality system compliance (e.g., follow processes and procedures as written).
- Maintains established metrics to monitor department activities and performance measures.
- Analyzes and improves existing documentation practices.
- Supports the company for all Quality System Regulations related to labeling in internals and external body audits, etc.
- Specific job knowledge of Technical Publications activities and requirements, change control and configuration management.
Knowledge and Skills
- Excellent skills in communication, negotiation, motivation and persuasion required.
Must have excellent technical writing skills and knowledge of desktop publishing and online help, including, but not limited to, Word, FrameMaker, RoboHelp, and WebWorks. Illustrating, graphics, and screen capture experience (PhotoShop, Corel Draw, Paint Shop Pro) a plus.
Demonstrates high degree of initiative and motivation with the ability to work independently and be a self-starter.
Ability to apply process and business judgment. Ability to plan and organization work while remaining flexible.
Ability to prepare and present information clearly and concisely to groups.
Ability to work with cross-departmental teams and all levels of employees
Demonstrates high degree of accuracy and quality.
Knowledge of word processor, spreadsheets, project management, and electronic document management software..
5 years direct documentation experience in medical device, software, pharmaceutical, or biotechnology industry.
Authoritative knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR 11), and control of electronic records.
Demonstrable record of working on project teams while working on multiple projects.
Experience with international regulatory requirements preferred
Bachelor's Degree in a scientific discipline or business administration or other related technical field.
Source: Job Diva – Job Listing