Job Title – Senior Technical Writer

Location - San Diego, CA

Duration – 12+ Months Contract

Client: Medical Device Company

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Apply your expertise as a Senior Technical Writer to help client advance the world of health.

In this position, you will add value to client by writing all types of customer-facing and internal-facing documents for so that they enhance our products’ usability, design intent, and our customers’ experience while complying with client style and government regulatory requirements.

Job Description
• Documents suites of BD 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.

Qualifications
• Bachelor's degree in English, Journalism, Communications, or other liberal arts degree.
• 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.
• 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.
• Experience in device labeling and/or packaging content development is a plus.
• Familiarity with large company engineering change control processes and Agile software development methodologies.
• Experience with Microsoft-based applications (Microsoft Office 365™)
• Minimum of two years' experience writing for online help
• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) system.
• Experience in version control systems (VCS) such as, Perforce, Apache™ Subversion™, Microsoft™ Team Foundation Server, or GitHub.
• Knowledge of screen capturing, photography, and image editing software such as Microsoft™ Paint or Adobe™ Photoshop™.
• Skilled in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft™ Word™, standard editorial and proofreading symbols).
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap™ Flare, Adobe™ FrameMaker™, Adobe™ InDesign™, Adobe™ Illustrator™) as applicable for technical documentation.