Sr. Associate, Labeling

Position Purpose

Technical writing to support Regulatory Labeling and User Manual development across medical device portfolios. This role focuses on creating, editing, and maintaining user manuals using structured content approaches (XML formatting tools, e.g., Madcap Flare), while partnering closely with Regulatory Affairs, Labeling, R&D, and Translation teams.

The role also supports development of a broad range of medical device documentation by translating engineering and product inputs into clear, accurate, and compliant content.

In addition to authoring responsibilities, this role supports end-to-end labeling content execution activities, including coordination of translations and alignment of labeling content across global and local markets.

Functional/technical
know how:

Individual must be flexible and capable of prioritizing projects, meeting deadlines, and working well under pressure. Must have strong interpersonal, organization, communication (both oral and written), proofreading, and basic project coordination skills.

Demonstrated ability to:

• Interpret technical specifications, engineering documentation, and product requirements
• Translate technical information into clear, user-focused documentation
• Work with structured content and/or XML-based authoring environments
• Support development of diagrams, visuals, and supporting materials
• Operate within defined processes and regulatory requirements

Fundamental knowledge of labeling development, technical writing, and regulated environments is required.

Major Accountabilities (Limited to 5-7 bullet points)

Technical Writing & Content Management

• Develop, edit, and maintain user manuals and regulatory labeling content for medical devices (including surgical and/or software products)
• Author structured content using XML-based formatting tools (preferred: Madcap Flare or similar)
• Migration of legacy documentation (Word, PDF, and other unstructured formats) into structured authoring tools (for example, Madcap Flare), ensuring standardization and content reuse
• Interpret engineering and product inputs into clear, accurate, and compliant documentation
• Ensure content aligns with regulatory, quality, and usability standards

Content Development & Review

• Ownership of content lifecycle management, including version control, change impact assessment, and updates across product releases.
• Acquire subject matter knowledge through collaboration with R&D, engineering, and SMEs, and by reviewing technical specifications and supporting documentation
• Support development and selection of illustrative materials (diagrams, charts, visuals)
• Perform quality reviews for clarity, consistency, and completeness
• This role does not have final review and approval of documentation - this is managed by appropriate SMEs

Translation Coordination

• Coordinate translation activities for labeling and user manuals
  • Manage handoffs to translation vendors/tools
  • Track progress, timelines, and deliverables
• Review translated documents for formatting, completeness and alignment (not responsible for translated content itself)

Systems & Tools

• Work within and across systems such as:
  • Madcap Flare (preferred) or other XML authoring tools
  • Teamcenter (preferred experience) for content and change context
• Support structured content management and integration with broader labeling systems
• Utilize Adobe tools (e.g., Illustrator, Photoshop) for content support as needed

Cross‑Functional Collaboration

• Partner with Regulatory Affairs, Engineering, Product Development, and Quality
• Ensure alignment between technical requirements, labeling content, and downstream outputs (e.g., artwork, manuals)
• Support documentation deliverables within defined project timelines

Background:

Education:

• Minimum: Bachelor’s degree Technical Writing, Journalism or English, or technical degree     

Languages:

• Fluency in English essential

Experience/Professional Requirement:

• Minimum: 2-5 years technical writing/labeling experience in the medical device or pharmaceutical industry
• Experience developing technical documentation for electromechanical or software-based products preferred
• Experience developing user manuals, IFUs, service manuals, and/or other regulated documentation aligned with global standards.
• Familiarity with regulated environments (e.g., EU MDR, IEC 60601) preferred
• Exposure to structured content and/or XML authoring tools preferred

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