West Point, Pennsylvania

Sr. CER Technical Writer

Remote 

 

Kelly FSP is hiring a Remote Sr CER Technical Writer to work directly with one of our major pharmaceutical clients. This role is a full-time, salaried opportunity offering our enhanced benefit package. As a Kelly employee within this group, you will be eligible for our benefit options including Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly FSP employees receive annual performance reviews.

The CER Technical Writer must have experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation to be considered. This is a remote position to work out of your home office full time. 

POSITION DUTIES & RESPONSIBILITIES:

  • Responsible for the writing of Clinical Evaluation Plans
  • Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance to local procedures, the client’s guidelines and regulatory requirements
  • Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, the client’s guidelines and regulatory requirements
  • Ensures the CER and SSR 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.  S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners 
  • Assists in the development of schedules to ensure operating company CER/SSR 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 reports. 
  • Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process

EDUCATION & EXPERIENCE REQUIREMENTS:

  • BA, BS, or BSN is required; advanced degree is preferred 
  • A minimum of 3 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
  • 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 preferred

#ACRP 



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Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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West Point, Pennsylvania

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