• CER Writer

    Kelly ServicesREMOTE, MA

    Job #1255264648

  • Kelly is hiring to work directly with one of our major pharmaceutical clients. 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 processEDUCATION & 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 preferredThis position comes with enhanced benefits which include:+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)+ Paid sick days and vacation daysbenefits to be received upon meeting eligibility requirements_Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume._*Why Kelly ® ?As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.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. 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.#KellyGTS