Technical Writer - Project Manager (regulatory & product labeling)- 3210 (closed)
-Technical Writer/Project Manager.
-BA/BS in Technical Writing or related field -2-4 years of writing experience with some project management experience (certification not necessary) or 2-4 years of PM experience with some technical writing experience
-Recent experience working in Framemaker, XML content management systems, and document control/configuration mgmt. systems
-Experience working in regulated industry a plus
-Provide technical writing and project management support for medical device industry product labeling projects within CRDM Technical Communications.
-Deliverables include clinician reference manuals, product inserts, instructions for use, etc.
-Users of this information may include regulators, clinicians, patients, and technical support representatives.
-May be asked to move quickly between project work and process development and do both writing and project mgmt.
-Need to be energized by change and able to stay flexible.
*Plan, research, and develop content or coordinates content development for technical writing projects
*Research products by reading product specifications and other documentation, interviewing subject matter experts, and investigating prototype hardware and software
*Support project teams as necessary, including facilitating decisions about distribution and local language plans and regulatory requirements, researching justification for historical changes content, etc.
*Maintain awareness of and ensure adherence to standards, laws, and process and content-related regulatory requirements, as well as internal procedures
*Develop, communicate and maintain project estimates, schedules, and status
*Coordinate layout and design of deliverables with graphic designer and/or print specifications expert
*Conduct content and quality reviews
*Maintain project-related records, working within a variety of document control and configuration management systems, processes and tools
*Apply creativity to solve problems related to processes, systems, and tools
THIS IS A 12 MO CONTRACT
RAvise@KeystoneCS.com (refer to #3210)