Senior Process Technical Writer

Pay Range: $70.00hr - $75.00hr

Job Overview:

The Technical Writer ensures that development and delivery of process documentation standard operating procedures (SOPs) is consistent and compliant with organization and regulated guidelines. The Technical Writer writes, edits, and maintains usable, accurate, clearly presented, and consistent internal process documentation. The role requires general guidance on new assignments and processes but is expected to complete day-to-day work with little instruction. This is a self-directed role requiring exceptional time management and communication skills.

Essential Job Duties:

• Write, edit, and maintain internal process documentation according to company templates and guidelines.
• Provide ongoing writing support to cross-functional teams as they transform their processes to the new company templates and guidelines.
• Develop and maintain process documentation flow charts.
• Collaborate with department team members and cross-functional Subject Matter Experts (SMEs) to learn internal processes to write, edit, and maintain process documentation.
• Ensure compliance with Quality, Document Control, and Good Documentation Practice (GDP) guidelines.
• Understand the document control steps required to release documentation and upload files to the document control system.
• Resolve complex issues in creative and effective ways, using skills as an experienced technical communication professional with an understanding of industry best practices and company objectives.
• Act as the lead writer on projects and mentor other writers as needed.
• Keep abreast of the basic requirements for compliance in own area of work and comply with those requirements.
• Participate as required in training on regulatory issues affecting own area of work and share learned expertise with others, bringing regulatory compliance questions or issues to the attention of management.
• Adhere to policies, procedures, style guides, and quality documents, collaborating with project team members to share knowledge and best practices.

Required Skills, Experience, Education, & Training:

• 5+ years writing or editing experience in a regulated environment focusing on internal process documentation standard operating procedures (SOPs).
• Bachelor's degree in communications, professional writing, XX, biological/medical/engineering sciences, or equivalent experience.
• Strong writing and grammar skills in areas of content development and writing style, with analytical ability to grasp and effectively communicate complex scientific and engineering concepts.
• Ability to understand and create flow charts.
• Strong organizational skills and ability to manage deliverables for multiple projects under tight deadlines, set priorities, and manage time effectively.
• Expert skill level using current versions of standard authoring tools, including Microsoft Word and Microsoft Visio.
• Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent tools.
• Previous experience with medical devices or a regulated environment.
• Ability to perform assignments with minimal instruction and supervision.

Preferred Skills, Experience, Education, & Training:

• Understanding of Document Control processes.
• Understanding of decision tracking software such as OneNote, Excel, and Smartsheet.
• Understanding of localization processes.