Clinical Evaluation Report (CER) Medical Writing Training Specialist

  • location: Deerfield, IL
  • type: Contract
  • salary: $65 - $74.34 per hour
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job description

Clinical Evaluation Report (CER) Medical Writing Training Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!

 
location: Deerfield, Illinois
job type: Contract
salary: $65.00 - 74.34 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • A CER Medical Writing Training Specialist: supports the Global Patient Safety (GPS) team by providing expertise in the development of Clinical Evaluation Reports (CERs) and other CER-related regulatory compliance documents; for example:

    • Clinical Evaluation Plans (CEPs),
    • Post-Market Surveillance Plans (PMS Plans),
    • Post-Market Clinical Follow-Up Plans (PMCF Plans),
    • Summary of Safety & Clinical Performance (SSCPs),
    • Post-Market Surveillance Reports (PMSR), and
    • Periodic Safety Update Reports (PSURs)
  • The CER Training Specialist provides guidance/direction to the medical writing team as to required analyses and documentation to comply with global medical device regulations (e.g., EU, China, Japan, Australia, etc.).
  • Developing a medical writing curriculum for CERs and CER-related regulatory compliance documents to be used for training new medical writers
  • Includes all bulleted documents above
  • Includes development of Global Guidances (GG) which outline the required steps/process flow to complete the documents bulleted above
  • Using the developed curriculum to provide training sessions to new medical writers
  • Developing a process for evaluating medical writing competency
  • Assisting with developing/revising processes and templates for the above documents to ensure compliance for EU and Rest of World regulations
  • Includes providing revisions if required to address feedback from Notified Bodies
  • Providing CER subject matter expertise as needed by CER teams during development of new CERs and remediation of existing CERs.
  • Maintaining knowledge of current CER regulations (globally) and best practices for document development and maintenance
 
qualifications:
  • A minimum of a Bachelor of Science required
  • A minimum of 5 years of experience writing Clinical Evaluation Reports (and related documents) for the medical device industry, required.
  • Experience developing training curriculums for medical writers, required. Experience developing these curriculums for CEP/CER/PMS/PMCF/SSCP/PMSR/PSUR, preferred.
  • Excellent leadership skills to:
  • Respond to new demands and challenges while working effectively in ambiguous situations
  • Work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
  • Strong writing, analytic and problem-solving skills required.
  • Self-motivated with exceptional follow through.
  • Experience in conducting literature searches and analytical evaluation of scientific data.
  • Strong organizational skills and meticulous attention to detail.
  • Ability to apply global regulatory authorities' regulations and/or guidance.
  • Excellent English written and oral communication skills and adult-education teaching skills
  • Proficient in Excel, Word, Outlook, PowerPoint, & SharePoint
  • Ability to work outside the standard 8 AM-5 PM work hours, when needed, to attend WebEx/t-con meetings with global colleagues
  • Ability to accommodate limited travel outside the US to provide training sessions
 
skills: MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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