Technical Writer

This is a full-time, remote opportunity supporting a Medical Device client through Kelly FSP (Functional Service Provider), a managed solution provider and business unit of Kelly Services, Inc. Full benefit options are available for Kelly FSP employees.

About the role

The Senior Technical Writer provides oversight and execution of Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance Reports (SSCP).

Responsibilities

• Plan and write CERs and SSCPs, and mentor junior technical writers.
• Conduct technical reviews to ensure document accuracy and compliance with local procedures, guidelines, and regulatory requirements.
• Partner with team members to address the needs of each contributor.
• Manage daily activities to ensure timelines are met.
• Participate in workshops and other initiatives to help define and continuously improve process efficiency.
• Engage in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
• Support and, at times, act as a subject matter authority during audits and inspections pertaining to processes and reports.
• Communicate business-related issues or opportunities to the next management level.
• Ensure compliance with all Company guidelines related to Health, Safety, and Environmental practices for self and any supervised staff.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

Requirements

• BA, BS, or BSN is required; advanced degree is preferred.
• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation.
• Strong verbal communication skills and ability to build interpersonal relationships.

Preferred Qualifications

• Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods.

Benefits

• Medical, Dental, and Vision coverage.
• 401K retirement plan.
• Paid time off, including holiday, vacation, and sick/personal time.
• A variety of other benefits to choose from.