Technical Documentation Specialist - Abiomed
Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Technical Documentation Specialist located in Danvers, MA. This role is open to remote work.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
Th is position will work closely with the Manager of Promotional and Educational Compliance as well as content creators across the enterprise. Assist in Global company growth by providing documentation that serve s our customers and meet local, federal and international regulations and guidance. This person will prepare instruction manuals, and other supporting documents that communicate complex and technical information to customers. This position has overall responsibility for managing the content, structure and consistency of Abiomed's instructions for product use documents. Th is position works with Regulatory, Advanced Clinical Training & Support, Product Management, Engineering, Marketing, and compliance.
K ey components of the position include:
- Ensures that all Instructions for Use (IFUs), are up to date and consistent with current product iteration, procedure and technique, and software version.
- Manages delivery of all final content, in multiple formats, and ensures its appropriately routed for approvals
- Ensure these customer facing documents are stored and distributed to all required locations in accordance to SOP-QA27
- Manage the translation process for these key and complex documents and ensure all images and terms in these documents are accurately represented in all training materials created from them.
- Ensure all documents comply with federal, state and industry regulations and standards as well as company branding and messaging.
- Copy e diting for grammar, punctuation, consistency, clarity, and style as defined by the company guidelines
- This job is centered around fact-checking and the oversight of medical and scientific materials. As well as fulfilling the need for a central location to our product specifications, per software and country.
- Assist in manag ing product Claims? matrixes and Clinical Publication Library for promotional and educational purposes
- Use Veeva Vault PromoMats to track and communicate these Claims to all Abiomed promotional and training material content creators
- Exercise excellent service standards and maintain high customer satisfaction through resolving problems by explaining the best solution, expediting correction or adjustments to provide resolution.
