Job Details

Senior Technical Writer (Product Labeling) Job

Company name
Boston Scientific Corporation

Location
San Jose, CA

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At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets.  The Urology and Pelvic Health business unit provides proven, leading solutions to treat kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders – more urology subspecialties than any other company. In addition, we continue to invest in gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids. These offerings can help healthcare providers advance patient outcomes, reduce procedure costs and enhance quality – enabling millions of men and women to regain control of their lives.  We have a robust product line and pipeline, and we will continue to make an investment in Urology and Pelvic Health.

 

The Product Labeling Senior Technical Writer creates and maintains compliant documentation such as instructions for use, product manuals, package labels, and other pertinent labeling support items working with InDesign, NiceLabel, and other comparable software systems. Revise existing product labeling content (create minimal new content when needed) and organize the layout and content of documents and templates. Enforce the Boston Scientific Quality System standards. Interpret and advocate industry technical writing standards and adapt them to BSC's needs. Initiate, coordinate, and lead cross-functional product labeling projects to meet business requirements.

Key Responsibilities

*Manages product labeling projects based on prioritization from management and planned business needs. *Revise existing product labeling content (create minimal new content when needed), organize the layout and content of documents and templates while maintaining the integrity of the secure original files. *Coordinates product labeling content and meets with Subject Matter Expert (SME) as necessary. *Develops the product labeling draft for the SMEs or project team. *Coordinates and manages technical document foreign language translations. *Coordinates commercial printing and proofing to ensure that printed materials meet specifications. *Creates, monitors, and communicates the status of Engineering Change Orders to ensure all deadlines are met. *Interfaces with Project Teams members, Boston Scientific Distributors, Country Managers communicating implemented labeling changes and proposed changes to promote awareness globally. *Audits the methodologies and procedures to ensure compliance to standards for documentation. *Facilitate and lead necessary efforts to improve labeling functions, processes, SOP’s, etc. *Manages, organizes, and communicates project information and project activities. *Interfaces cross-functionally within the product development team to acquire source material for documents and to develop understanding of the products and procedures. *Applies corporate and regulatory documentation requirements. *Participates in or leads department projects.

Boston Scientific is an Equal Opportunity Employer.

 

Posting Notes: [[filter2]]||(n/a)||Research & Development||[[mfield2]]

Company info

Boston Scientific Corporation
Website : http://www.bostonscientific.com

Company Profile
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.

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