POSITION SUMMARY:

The Manager, Labeling and Technical Writing, will organize and execute project based and compliance activities of all regulatory-related technical writing and labeling programs.  This role will be responsible for a compliant, efficient and sustainable global labeling function, using medical device labeling and technical writing best practices.  This hands-on role will provide supervision and mentorship to the technical writing and labeling staff, and will also serve as a Technical Writer on cross-functional project teams through the research, planning, organizing, and development of technical product literature solutions (such as user’s guides, IFUs, eIFUs and product labels), as well as manage translations of technical product literature and electronic interface.

PRIMARY DUTIES & RESPONSIBILITIES:

LABELING AND TECHNICAL WRITING PROJECT MANAGEMENT

Accountable for planning and allocating resources, preparing budgets, monitoring progress, and keeping stakeholders informed throughout the project lifecycle, supporting the company’s goals and vision.

MANAGEMENT OF TECHNICAL WRITING AND LABELING DESIGN FUNCTION

• Provide coaching and guidance to technical writing staff. Provide consultation on complex publication projects.
• Reviews technical literature prepared by other staff members as needed for content, completeness, and clarity.
• Promote employee development and foster growth of employees through:
  • Performance management
  • Skills development
  • Continuous one-on-one feedback
  • Real time appraisal of individual performance
  • Recognition and motivational techniques/tools to drive high levels of employee performance and engagement
• Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes.
• Identify resource needs (human, equipment, etc.) and communicate to management for improvement as needed, addition of capabilities, and future growth projections to support a growing business.

DEVELOP AND MAINTAIN TECHNICAL COMMUNICATIONS

• Research products by studying the product specifications, interviewing subject matter experts, using prototype hardware and software.
• Research, plan, write, edit, and coordinate the development of required product literature in the appropriate timeframes for product launch and in compliance with company operating procedures and work instructions.
• Ensure that product literature is consistent, clear, technically accurate, complete, and meets regulatory, marketing, and branding requirements.
• Commit to a scheduled completion date. Inform management if schedule requires adjustment.
• Support project teams by developing, communicating, and maintaining project estimates, schedules, and status.
• Organize and facilitate content and quality reviews of assigned user guides and IFUs.
• Edit documents, making technically and stylistically appropriate modifications.
• Manage the change order release of product documentation and labels using Agile.
• Update existing technical literature and labels as required.
• Assist in the maintenance of internal systems and procedures to ensure consistency of format, style, clarity, safety, and technical accuracy.
• Manage outside vendors such as enterprise system providers, illustrators, photographers, and printers, ensuring that they stay on schedule and within budget.
• Collaborates with development engineering, marketing, regulatory affairs, and clinical engineering personnel, among others, to ensure accuracy and completeness. Recommends overall organization and layout, mode of presentation, publication methods and the like. Develops publications concepts for the best communication of subject matter. Recommends editorial standards.
• Tracks and communicates project status (internally and externally).
• Manage language translations of literature and localized software user interface:
  • Define deliverables according to geographical requirements.
  • Oversee outside translation services for all localization activities, including in-country reviews.
  • Establish and maintain translated glossaries.
  • Manage linguistic validations of software.

OTHER DUTIES:

• Monitor regulatory environments worldwide and provide management with assessments of the impact of new or revised regulations.
• Develop and implement new departmental policies, processes and SOPs and train key personnel to them.
• Establish and support a work environment of continuous improvement that supports Quality Policy, Quality System and compliance with the appropriate labeling regulations for the area supported.
• Establish and maintain relationships with cross-functional departments including consultants and vendors

Required Skills

MINIMUM

• BS or BA degree

• 5 years previous technical writing and labeling design experience in the medical device industry (pharmaceutical equivalent experience can be used to partially fulfill this requirement).

• 3 years of medical device industry experience

• Demonstrated ability to write clearly and concisely and recognize and correct errors, gaps, and other limitations in written documentation.

• Project management experience, specifically the ability to prioritize/manage multiple projects simultaneously, sometimes with short or changing deadlines.

• Excellent analytical skills and ability to manage complex tasks and manage time effectively.

• Experience working with collaborative, cross-functional teams

• Advanced personal computer skills including Microsoft Office Suite: Teams, Excel, PowerPoint, Word, Outlook, SharePoint

• Proficient in inDesign, Illustrator, Photoshop, and Acrobat, familiarity with labeling enterprise software desired.

• Working knowledge of medical device labeling regulations.

• Experience with translation projects and working in a global environment.

• Experience working with complex hardware and software systems and engineering teams.

• Experience with managing vendor relationships.

• Excellent verbal and written communication and interpersonal skills.

• Strong attention to detail, able to identify missing information, and evaluate accuracy of presented information.

• Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes and policies.

PREFERRED:

• Experience with enterprise labeling solutions.
• Project management experience.
• Prior supervisory or team lead experience
• Experience in medical technology or software end-user documentation.
• Familiarity with electronic delivery on web sites.
• SGML, HTML, or XML authoring experience.
• Experience using Agile or SAP software.

OTHER:

• Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and the employee may be exposed to high-pressure situations. 
• Travel requirements are minimal (less than 15%).

Required Experience

MINIMUM

• BS or BA degree

• 5 years previous technical writing and labeling design experience in the medical device industry (pharmaceutical equivalent experience can be used to partially fulfill this requirement).

• 3 years of medical device industry experience

• Demonstrated ability to write clearly and concisely and recognize and correct errors, gaps, and other limitations in written documentation.

• Project management experience, specifically the ability to prioritize/manage multiple projects simultaneously, sometimes with short or changing deadlines.

• Excellent analytical skills and ability to manage complex tasks and manage time effectively.

• Experience working with collaborative, cross-functional teams

• Advanced personal computer skills including Microsoft Office Suite: Teams, Excel, PowerPoint, Word, Outlook, SharePoint

• Proficient in inDesign, Illustrator, Photoshop, and Acrobat, familiarity with labeling enterprise software desired.

• Working knowledge of medical device labeling regulations.

• Experience with translation projects and working in a global environment.

• Experience working with complex hardware and software systems and engineering teams.

• Experience with managing vendor relationships.

• Excellent verbal and written communication and interpersonal skills.

• Strong attention to detail, able to identify missing information, and evaluate accuracy of presented information.

• Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes and policies.

PREFERRED:

• Experience with enterprise labeling solutions.
• Project management experience.
• Prior supervisory or team lead experience
• Experience in medical technology or software end-user documentation.
• Familiarity with electronic delivery on web sites.
• SGML, HTML, or XML authoring experience.
• Experience using Agile or SAP software.

OTHER:

• Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and the employee may be exposed to high-pressure situations. 
• Travel requirements are minimal (less than 15%).