Technical Writer

Position Summary:

TheTechnical Writer is responsible for researching, writing, and editing documentation to maintain quality and consistency within guidelines established by the Writing and Training team, with additional input from Functional Area Managers (FAMs). The Technical Writer will ensure regulatory compliance and will collaborate with Subject-Matter Experts (SMEs) and FAMs to ensure accuracy of documentation.

Job Responsibilities:

• Develop and assist with the development of Standard Operating Procedures (SOPs), Work Instructions (WI's) or other quality based documents
• Research instruction manuals, and interacts with SME's of equipment to ensure accuracy of work instructions
• Collaborate effectively across departments
• Assist with quality improvement initiatives
• Keep department management up to date
• Seek guidance on resolution of complex issues
• Prepare, process, issue, and close change control documentation as applicable
• Performs analysis and trending as required for documentation updates
• Create, revise, and maintain master batch records as applicable
• Provide documentation support for quality systems
• Act as a resource for documentation required of various functions
• Provide training in areas of expertise, as needed
• Perform other duties as assigned

Required Skills:

• Exceptional written and verbal communication skills
• Exceptional technical research and organizational skills
• Ability to meet varying deadlines
• Ability to coordinate projects involving input from multiple participants
• Ability to work independently, when necessary
• Proficiency in Microsoft Office applications (e.g., Word, Excel, and PowerPoint) and Adobe Acrobat

• Good organizational skills; ability to respond to multiple priorities and meet varying deadlines; ability to coordinate projects involving input from multiple participants

Education and Experience Requirements:

• BA or BS degree preferably in scientific discipline, or related field, with a strong writing background required
• One (1) year of experience in the pharmaceutical industrypreferred. However, a combination of education and experience will be taken into consideration.
• Experience with document control systems a plus (e.g., Veeva, DMS (Sparta), Adobe, Docu-Sign, etc.).

EOE, including disability/vets.