Kelly Services Technical CER Writer in Raynham, Massachusetts
Technical CER Writer in Medical Operations
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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 email@example.com.
*benefits to be received upon meeting eligibility requirements