Senior Technical Writer

Roles & Responsibilities

• Documents suites of client products, including hardware and software user guides, installation guides, communication / service bulletins, tip sheets, product and device labels, and online documentation.
• Reviews product data, requirements, specifications, drawings, part lists, and prototypes to develop customer-facing and internal-facing documentation.
• Ensures accuracy, clarity, appropriateness, and consistency of documents; peer reviews documents developed by other writers when appropriate.
• Manages the labeling review process and prepares documents for production.
• Collaborates with quality, regulatory, clinical, marketing managers, engineers, and other subject matter experts to determine type of content and level of detail to be used in product labeling especially IFU and to suggest changes to enhance a document 's readability, clarity, conciseness, and style.
• Communicates effectively with all levels of management, business units (corporate and international), and possesses a high degree of flexibility / selectivity in prioritizing business unit deliverables to meet company goals.
• Adheres to established templates and guidelines for developing product labeling (documentation).
• Manages the labeling review process and prepares documents for final production and release.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participates as required in training on regulatory issues affecting own area of work.

Experience Required

• Experience working in a regulated industry such as pharmaceuticals or medical devices.
• Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.
• Experience with Microsoft-based applications (Microsoft Office 365)
• Experience in device labeling and / or packaging content development is a plus.
• Experience in version control systems (VCS) such as, Perforce, Apache Subversion, Microsoft Team Foundation Server, or GitHub.
• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system.
• Minimum of two years ' experience writing for online help
• Knowledge of screen capturing, photography, and image editing software such as Microsoft Paint or Adobe Photoshop.

Skills & Certifications

• Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers.
• Five or more years writing and editing hardware / software user guides (print and online) and other technical product documentation.
• Ability to effectively manage the delivery of prioritized tasks.
• Ability to demonstrate a high level of initiative to gather information for developing documentation.
• Ability to work independently with minimal supervision.
• Effective at thinking independently and solving problems with product core team members.
• Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.
• Ability to handle multiple projects with excellent follow-up and project management skills.
• Familiarity with electro-mechanical concepts and software application usage.
• Familiarity with large company engineering change control processes and Agile software development methodologies.
• Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft Word, standard editorial and proofreading symbols).

Eligibilities & qualifications

• Bachelor 's degree in English, Journalism, Communications, or other liberal arts degree.
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator) as applicable for technical documentation
30+ days ago