Technical Writer II

• Collaborate with multiple departments, including Q&R, R&;D, Engineering, and document control, to establish standardized procedures and work instructions in accordance to PIL, PQMS, and Excellence Process Framework requirements. 
  


• Collaborate with users and subject matter experts to ensure functional requirements and technical specifications are aligned per written procedures. Collect data by interviewing specialists, technicians, review of written materials and observing users. 
  


• Understand and document linkages, relationships and dependencies. 
  


• Communicate effectively with team members and other groups to ensure consistent and complete requirement documentation. 
  


• Escalate issues to management as appropriate and in a timely fashion Acquire and apply knowledge of the business and of overarching standards that apply to the project scope Ability to embed images, system screen shots in procedures to illustrate documentation. 
  


• Author and/or revise QMS documentation (SOPs, Work Instructions, forms, templates) using document management system. 
  


• Participate in project teams and successfully manage complex, multiple projects from concept to release under tight deadlines Ability to rapidly adapt and respond to changes in environment and priorities. Participate in the development of training material that will be used to support the deployment of the system 
  

Requirements

• Bachelor’s degree or equivalent combination of education and experience. 
  


• Pharmaceutical and/or medical device experience preferred.
  


• Understanding of cGMP, ISO13485, and regulatory requirements
  


• Three years of experience working as a technical writer.
  


• Project management experience preferred.
  


• Exceptional technical writing skills, excellent verbal communication skills. 
  


• Well-organized, efficient, and able to prioritize work and meet deadlines. 
  


• Must have a can-do attitude and commitment to stay in organization more than 90 days
  


• Able to work independently, detail oriented in order to generate accurate and precise work. Ability to collaborate and work with all levels of management and staff.
  
  

Benefits