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PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.

SUMMARY

As Procept continues to grow and widen its global footprint the Regulatory Affairs team now needs to hire a talented Senior Technical Writer – Product Labeling to provide labeling expertise for new and existing robots from development through marketing approval and commercialization. You will be responsible for the definition and generation of Labeling content and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards for labeling. In addition, you will bring your collaboration skills to provide labeling expertise and guidance to our project teams

The initial role of the Senior Technical Writer – Product Labeling will be as an individual contributor and you will report to the Manager, Labeling and Regulatory Intelligence.

CORE RESPONSIBILITIES

  • Develop and write the labelling content for current and new product introductions.
  • Design product labels and manuals
  • Responsible for labeling content asset management
  • Research and interpret labeling regulations, standards and guidance.
  • Assist in providing labeling guidance and actively participate/collaborate with cross-functional teams
  • Coordinates outsourced labeling activities such as translations.
  • Execute change orders as needed for labeling document release.
  • Assists in continuous improvement to labeling process.
  • Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
  • Understand and adhere to the PROCEPT BioRobotics EHS Policy

QUALIFICATIONS (Education, Experience, Certifications)

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
  • Bachelor’s degree in a scientific or engineering discipline. 
  • 5+ years experience working in a technical writing / labeling position
  • Excellent oral and written communication skills
  • Proficiency in graphic design and desktop publishing software, including Adobe Creative suite
  • Proficiency in document or content management systems
  • Experience working within a quality management system is preferred
  • Knowledge of international medical device labeling standards is preferred.
  • Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Strong organization skills, able to manage multiple projects and timelines
  • Ability to work independently as an individual contributor and in a team environment

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
  • To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel safely within the facility. The employee may occasionally lift and/or move up to 15 pounds. 
  • While performing the duties of this job, the employee regularly works in an office environment. 
  • COVID-I9 Vaccine Requirement: All PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.

For US Based Candidates Only

For this role, the anticipated pay is $109,000 - $150,000 a year.

PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.

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Confirmed 18 hours ago. Posted 12 days ago.

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