Technical Writer II

Description: This position is not Project Client related -


Hybrid position - 3 days (preferably T, W, TH) onsite in AH.


* Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. Client is not able to consider candidates who require sponsorship.


Possible temp to hire for right individual and if budget is approved.
Midpoint salary upon conversion is approximately ***
Suppliers, include conversion expectations on submittal form, within reason of above.


Job Purpose
The Technical Writer II is responsible for developing, editing, and maintaining high-quality Instructions for Use (IFUs) and labels that support clinician use, patient safety, and regulatory compliance. The ideal candidate is detail-oriented, collaborative, and skilled at translating complex technical information into clear, user-focused content.


Key Responsibilities
• Writing: Exceptional writing and communication skills.
• Document Authoring: Create and update clinician IFUs, patient manuals, and product labels.
• Cross-Functional Collaboration: Lead documentation reviews with engineering, quality, clinical, regulatory, marketing, and manufacturing teams to ensure technical accuracy and regulatory compliance.
• Regulatory Compliance: Ensure all materials conform to strict standards including FDA guidelines, ISO norms, and EU MDR requirements.
• Document Control: Create and maintain precise revision histories and supporting documentation for risk management.
• Project Management: Create and adhere to project plans for document completion. Manage multiple projects simultaneously as required.


Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.


Required Qualifications:
• Education: Bachelor's degree in Technical Communication, English, Biomedical Engineering, or a Life Science discipline.
• Experience: Minimum of 2+ years of technical writing experience within a regulated, medical, or manufacturing environment.
• Technical Proficiency: Mastery of tools like Microsoft Office Suite, Adobe Creative Suite, and experience using Content Management and Quality Management Systems.
• Core Competencies: Exceptional eye for detail, critical thinking, strong cross-functional communication skills, maintenance of effective relationships with subject matter experts, and the ability to simplify dense terminology.


Preferred Qualifications:
• Advanced degree in technical communications, English or similar
• Document creation using an XML-based content management system
• Writing for multiple audiences (clinicians and patients)
• Strong attention to detail
• Knowledge of medical terminology and anatomy
• Proven understanding of literature and labeling development in a heavily-regulated environment
• Use of critical-thinking and problem-solving skills to identify risk and develop creative solutions


Custom Fields:
Name: SCL Dept #
Value: None


Name: BSC Company Code
Value: None


Name: BSC SAP Project/ Client Number
Value: None


Name: BSC GL Number
Value: 501061 Temporary Help - Indirect Labor