Kelly Services Technical CER Writer in Raynham, Massachusetts
Technical CER Writer in Medical Operations
KellyOCG FSP is seeking candidates for a Technical CER Writing opportunity in the USA. Candidates must have previous Clinical Evaluation Report (CER) writing experience, orthopedic experience is a plus. This is 100% remote-based, is an open-ended engagement and comes with enhanced benefits (see below).
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.
*benefits to be received upon meeting eligibility requirements
Why Kelly ® ?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
About Kelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
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