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12 days old

CER Technical Writer - Remote

Kelly Services
Raynham, MA 02767 Work Remotely
  • Jobs Rated
    43rd
**Technical Writer in Medical Operations**


_KellyOCGs 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. This is an [open ended] engagement and comes with enhanced benefits (see beneath)._


**OVERALL RESPONSIBILITIES:**


The Technical Writer, Shared Services acts as a team member supporting and executing the Clinical Evaluation Report and Safety Surveillance Report processes for the assigned therapeutic areas within the MD businesses within his/her scope of responsibility


**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 clients guidelines and regulatory requirements

+ Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, the clients 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 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 preferred


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Jobs Rated Reports for Technical Writer

Posted: 2022-06-15 Expires: 2022-07-16

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CER Technical Writer - Remote

Kelly Services
Raynham, MA 02767

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Technical Writer
43rd2019 - Technical Writer
Overall Rating: 43/199
Median Salary: $71,815

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Growth
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