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Kelly Science, Engineering, Technology & Telecom · 3 weeks ago

Senior CER Technical Writer

United States

Full-time

Remote

Senior Level

Kelly Science, Engineering, Technology & Telecom is seeking a Senior Technical Writer to provide oversight and execution of Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance Reports (SSCP). The role involves conducting technical reviews, managing timelines, and ensuring compliance with regulatory requirements.

Staffing & Recruiting

Hiring Manager

Kellie Pharr

Responsibilities

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

Responsible for communicating business related issues or opportunities to next management level

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualification

CER regulatory requirementsClinical researchMedical device industryQuality regulatory complianceAdverse event reportingRisk management processInterpersonal relationshipsCommon statistical methodsVerbal communication

Required

BA, BS, or BSN is required

Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation

Strong verbal communication skills and interpersonal relationships

Preferred

advanced degree

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