
Senior Technical Writer
- Arden Hills, MN
- $69,500 per year
- Permanent
- Full-time
- Collaborates with divisional Quality, Regulatory, Medical Safety, Legal, Marketing and Corporate Communications Leadership in support of the Field Action Process
- Monitors potential Field Actions. Coordinates with Field Action Team Lead to assess project priority and monitor progress to ensure timelines are met.
- identifies cross-functional subject matter experts and secures required technical and clinical information
- Creates the draft communication, incorporating information from subject matter experts while refining the customer letter content through clarifying questions, anticipation of audience needs, and team discussions
- Coordinates review/edit/approval process per department procedure. Ensures accuracy, readability, and consistency while meeting corporate and regulatory documentation requirements
- Finalizes field action communications and collaborates with the FATL to support downstream activities to successfully complete Field Action Commencement
- May prepare website-posted field action information to meet regulatory requirements, patient needs and to broaden delivery and effectiveness of Boston Scientific field action communications
- Initiates and supports continuous improvement activities at a personal, department and cross-functional level. Collaborates with Global Field Action Team on these initiatives
- Bachelor's degree and a minimum of 4 years of relevant experience is required, preferably within a regulated industry such as medical devices, pharmaceuticals or biotechnology. Alternatively, candidates with a Master's degree should have at least 3 years of relevant experience in a regulated environment
- Bachelor's degree in communications, technical writing, or related technical field such as science, health or engineering preferred.
- Medical device/regulated industry experience
- Previous communication experience with government regulators and physician-customers
- Familiarity with Post Market, Field Action (Recall) and Quality System processes
- Project Management skills
- Problem solving skills and an ability to respond and adapt to change
- Familiarity with Boston Scientific products, including associated product labeling
- Strong communication, writing, editing, and presentation skills
- Able to work quickly and efficiently on documents and tasks while still maintaining high quality in work
- Proactive work habits and assertiveness in creating and owning documents
- Aptitude to understand engineering and other technical information
- PC literacy in word processing, spreadsheets, presentation applications, and database management