Senior Technical Writer - Medical Device Business Services, Inc.
DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Technical Writer. This role is responsible for providing oversight and execution of EU Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) Reports within the Synthes GmbH Trauma, Craniomaxillofacial (CMF), and Biomaterials businesses. This role can work remotely from anywhere in the United States .
DePuy Synthes 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.
· Planning and writing CERs and SSCPs and mentoring junior technical writers.
· Conducting technical reviews to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements.
· Partnering with team members to address needs of each contributor.
· Managing daily activities to ensure timelines are met.
· Participating in workshops and other initiatives to help define and continuously improve process efficiency.
· Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
· Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports.
The base pay range for this position is $105,000 to $150,000 based on experience . The 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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees 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.
· Minimum of a Bachelors’ Degree is required , preferably in a Science related field OR Nursing; Advanced Degree is highly desired .
· Minimum of 5 years of related Clinical and/or Technical Writing experience in a highly regulated industry.
· Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation.
· Elite written & verbal communication skills and interpersonal skills
· Willingness & ability to travel up to 10% domestically.
· Demonstrated knowledge and experience in quality, regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical methods preferred .
· Regulatory/Notified Body audit experience strongly preferred .
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.