Kelly Services is seeking a Clinical Evaluation Report Specialist for a one-year assignment. Candidates will ideally work in Deerfield, IL however remote-based candidates will be considered. A CER Specialist supports the Global Patient Safety (GPS) teams by providing expertise in the development and maintenance of Clinical Evaluation Reports (CERs) and other CER-related regulatory compliance documents; for example, Clinical Evaluation Plans, Post-Market Surveillance Plans (PMS Plans), Post-Market Clinical Follow-Up Plans (PMCF Plans), and Summary of Safety & Clinical Performance reports (SSCPs). The CER specialist provides guidance as to required activities and documentation to comply with global medical device regulations (e.g., EU, China, Japan, Australia, etc.).
Qualified candidates will have extensive knowledge in understanding and complying with country-specific regulations/requirements, understand the CER process, have template development expertise, CER knowledge beyond just the EU, Clinical Evaluator Role Expertise (for training purposes).
Essential Duties and Responsibilities:
- Providing medical writing of CEPs, CERs, PMS/PMCF Plans, SSCPs, etc.
- Providing process and template compliance guidance for CEPs, CERs, PMS/PMCF Plans, etc. for EU and Rest of World regulations
o Supporting the CER Process Owner with the development of the Clinical Evaluation (CE) Plan, CER and SSCP Global Quality Processes, Global Quality Templates, Global Guidances (work instructions) for EU-CER Accepting Countries as well as Rest of World. And, once issued, supporting the implementation of these same processes/documents.
- Providing CER SME support as needed by CER teams during development of new CERs and remediation of existing CERs.
- Providing an early review of all drafted CERs to ensure all regulatory requirements have been met, as well as a final review & approval of all CERs prior to the CER being released to the Notified Body (NB).
- Leading individual CER teams in the resolution plan for any identified deficiencies during CER development or as a result of deficiencies identified by Notified Bodies (NB).
- Developing and providing a training program and continuous education curriculum for both CER Medical Writers and Clinical Evaluators
- Providing SME support for 2019 China CER regulations; guiding the CER development teams as to requirements to meet the new regulations.
- Maintaining knowledge of current CER regulations (globally) and development/maintenance best practices
- Excellent leadership capabilities and strong project management skills to:
o respond to new demands and challenges while working effectively in ambiguous situations
o work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
- Well-developed interpersonal skills with excellent verbal and written communication skills, public speaking and teaching skills
- Excel (Pivot Table & V-Lookups, reporting, strongly preferred), Word, Outlook, PowerPoint, & SharePoint
Education / Experience
- A minimum of a Bachelor’s of Science
- A minimum of 8 years of experience in writing Clinical Evaluation Reports for the medical device industry. Strong knowledge of what is required to be compliant to the latest regulations.
- Experienced candidates who have developed CEP/CER/PMS/PMCF/SSCP Training programs for medical writers and clinical evaluators who are new to CERs, preferred.
- A minimum of 3 years of project management experience, is preferred.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Group rate insurance options available immediate upon hire*
- Service bonus plan and holiday pay*
- Online application system
- Never an applicant fee
*perks 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.
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