SOP Writer - Regulatory/Medical Devices

The Technical Writer ensures that development and delivery of process documentation standard operating procedures (SOPs) is consistent and compliant with company and regulated guidelines. The Technical Writer writes, edits, and maintains usable, accurate, clearly presented, and consistent internal process documentation. The Technical Writer 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 template and guidelines.

•Provide ongoing writing support to cross-functional teams as they transform their processed to the new company templates and guidelines.

• Develop and maintain process documentation flow charts

• Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to learn their 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 which are required to release documentation. Upload files to the document control system.

• Resolve complex issues in creative and effective ways, using skills as an experienced technical communication professional with 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 complies with those requirements.

• Participate as required in training on regulatory issues affecting own area of work and share learned expertise with others. Bring regulatory compliance questions/issues to the attention of management

• Adhere to policies, procedures, style guides, and quality documents. Collaborate 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 SOPs

• Bachelor’s degree in communications, professional writing, English, biological/medical/engineering sciences, or equivalent

• Strong writing and grammar skills in areas of content development and writing style. 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 ofAdobe Illustrator, Adobe Photoshop, or equivalent

• Previous experience with medical devices or a regulated environment

• Perform assignments with minimal instruction and supervision

Preferred Skills, Experience, Education, & Training:

• Understanding of Document Control processes preferred

• Understanding of decision tracking software such as OneNote, Excel, and Smartsheet preferred

• Understanding of localization process preferred