Senior Technical Writer

Company: J&J Family of Companies
Location: Boise
Posted on: January 26, 2023

Job Description:

Senior Technical Writer - 2206097263WDescriptionDePuy Synthes is recruiting for a Senior Technical Writer, Medical Operations, located in Warsaw, IN! Remote work options may be considered on a case by case basis if approved by the company.DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.Key Responsibilities:

• Responsible for the technical review ensuring the accuracy and compliance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance (SSCP) documents
• Responsible for compliant writing of Clinical Evaluation Reports and Plans within this business in accordance to local procedures, J&J guidelines and regulatory requirements
• Responsible for ensuring compliant creation of SSCP documents within this business in accordance to local procedures, J&J guidelines and regulatory requirements
• Ensures the CER and SSCP files are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. They will develop, implement, and manage an effective communication model for CERs/SSCPs with cross functional business partners
• Assists in the development of schedules to ensure operating company CER/SSCP timelines are met
• Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
• Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reportsQualificationsEducation:
  • BA, BS, or BSN is required; advanced degree is preferredExperience and Skills:Required:
    • A minimum of 5 years of related job experience is required for this position
    • Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
    • Fluent both oral and written in EnglishPreferred:
      • Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
      • Regulatory/Notified Body audit experience is preferredOther:
        • Actively partners with cross-functional business partners such as Other Medical Operations Team Members, Medical Affairs, Regulatory Affairs, Product Development, Clinical Research, Post Market Surveillance, Quality Engineering, and Patient Harm Coding, in the planning and execution of the clinical evaluation process
        • Works with vendors/service providers to source contract services necessary to accomplish their goals and objectives
        • 10% Domestic and International Travel requiredThe Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.The base pay range for this position is $102,000 to $142,000The base pay range for this position in the Bay Area of California is $116,700 to $163,300Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.https://www.careers.jnj.com/employee-benefitsAt Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Primary Location NA-US-Indiana-WarsawOther Locations NA-United StatesOrganization Medical Device Business Services, Inc (6029)Relocation Eligible: NoTravel Yes, 10 % of the TimeJob Function Medical AffairsReq ID: 2206097263W

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