Boston Scientific Principal Technical Writer 

United States, California, Santa Clarita 

780795343

You Responsibilities will include:

• Co-author or contribute to the creation and revision of medical device labeling deliverables.
• Manage, organize, and communicate project information and project activities.
• Apply corporate and regulatory documentation requirements.
• Lead teams of technical writers with regard to organizingInstructions for Use content for medical device regulatory submissions.
• Participate in or lead technical communication projects.
• Create and maintain technical communication project schedules, driving milestones to completion.
• Interface cross-functionallyto acquire source material for documents and to develop understanding of the products and processes.
• Lead the implementation of an XML-based product literature Component Content Management System (CCMS). This includes strategy and training development.
• Lead the migration of medical device content info a CCMS, using expertise in structured authoring and content reuse strategies.

Required Qualifications:

• 8+ years of experience working as a technical writer within the technology field, or 5+ years with an advanced degree/related experience
• Experience creating medical device Instructions For Use
• Bachelor’s degree
• Experience using InDesign to create medical device labeling deliverables
• 4+ years leading and mentoring technical writing teams
• 4+ years managing technical communication project schedules
• Expert knowledge of the Technical Communications landscape, including demonstrated expertise in structured writing, style guides, and content editing
• Demonstrated experience working under the guidance of standard operating procedures governing the development of medical device products
• Expertise with XML based Component Content Management Systems consisting of medical device literature objects
• Expertise in product literature data migration into XML databases
• Expertise in structured authoring and content reuse strategies
• Familiarity with XML based content style sheets

Preferred qualifications and competencies:

• Bachelor degree in Scientific and Technical Communications, or technical writing certification
• PMP certification
• Demonstrated knowledge of the code of federal regulations governing medical device labeling
• Knowledge of XML plus DITA and/or DocBook
• Experience working with medical device labeling translations, including authoring content for translatability

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
• Demonstrated knowledge of the global regulations governing medical device labeling. This includes expert knowledge of 21CFR 820, 21CFR 801, EU MDR, all applicable EEC directives, etc.

Pay Transparency

The anticipated annualized base pay range this full-time position working at this location will be from $84,000 - $159,600, plus variable compensation, i.e., annual bonus target2 (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at . At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. BSC considers various factors in determining actual compensation for this position at the expected location. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.