Kelly Services Technical CER Writer in Raynham, Massachusetts

Technical CER Writer in Medical Operations

With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year. KellyOCG’s Functional Service Provider (FSP) program provides centrally managed solutions to clients regulatory, medical and clinical affairs teams servicing a vast range of client across the US.

KellyOCG FSP is seeking candidates for a Technical CER Writing opportunity in the USA. Candidates must have previous Clinical Evaluation Report (CER) orthopedic writing experience. This is an open-ended engagement and comes with enhanced benefits (see below). The position is remote-based but candidates will ideally be located near one of the following locations: Raynham, MA; Warsaw, IN; West Chester, PA; Cincinnati, OH; Somerville, NJ; Irvine, CA.

The Technical Writer is a shared service team member supporting and executing the Clinical Evaluation Report (CER) and Safety Surveillance Report (SSR) processes for the assigned therapeutic areas within the medical device businesses within his/her scope of responsibility.

POSITION DUTIES & RESPONSIBILITIES:

  • Responsible for the writing of Clinical Evaluation Plans

  • Responsible for compliant writing of CERs in accordance to local procedures, the client’s guidelines and regulatory requirements

  • Responsible for ensuring compliant creation of SSR reports 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 CER regulatory requirements, evidence generation, and CER document creation is required

  • Writing experience with either joints and spines or general ortho-like instruments, pins and screws 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

This position comes with enhanced benefits which include:

  • 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

  • 10 Accrued Vacation days, 5 sick days, 9 holidays*

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

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. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

*benefits to be received upon meeting eligibility requirements