Manager, Technical Writing
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
The Manager, Technical Writing will ensure the smooth functioning of all regulatory-related technical writing projects for customers and project teams. This role will maintain optimal department processes, implement project-specific strategies, assist with the development and implementation of department strategies to increase productivity and quality, and provide supervision and mentorship to the technical writing staff. This hands-on role will also serve as a Technical Writer on cross-functional project teams through the research, planning, organizing, and development of technical product literature (such as user’s guides, IFUs, and product labels), as well as manage translations of technical product literature and work with software engineers to localize software and develop translation glossaries and translation reference materials to aid the translation process.
Primary Duties and Responsibilities:
Management of Technical Writing 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
- Bi-annual 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 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.
- Work with outside translation services for all localization activities, including in-country reviews.
- Establish and maintain translated glossaries.
- Manage linguistic validations of software GUI.
- 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.
Qualifications (Knowledge, Skills & Abilities):
- BS or BA degree in Technical Writing, English, Communications, or a technical field with coursework in technical writing.
- Previous technical writing experience in the medical device industry (8 years minimum).
- 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
- Advanced personal computer skills including MS office or equivalent
- Expert level at using InDesign in creation of user guides, IFUs, and labels.
- Proficient in Illustrator, Photoshop, and Acrobat.
- Knowledge of medical device regulations as they relate to labeling requirements.
- Experience with translation projects and working within an international organization.
- Experience working with complex hardware and software systems and engineering teams.
- Aptitude for new technologies and tools.
- Experience with managing vendor relationships.
- Excellent verbal and written communication and interpersonal skills.
- Excellent organization skills.
- Attention to detail.
- Ability to work collaboratively in a team environment
- Demonstrated ability to understand and comply with applicable regulations and Company operating procedures, processes and policies
- Prior supervisory or team lead experience
- Experience in medical technology and/or software end-user documentation.
- Familiarity with electronic delivery on web sites and CD-ROM.
- SGML, HTML, or XML authoring experience.
- Experience using Agile software.
- 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%).