Skills : Medical Writer,CER,Clinical Evaluation Report
Job Title: Clinical Evaluation Report (CER) Medical Writing / Training Specialist
Project: EU MDR related project, new role // Remote candidates will be okay but local candidates are strongly preferred. // Looking to fill this quickly, if candidate is remote manager is flexible and can do a Video WebEx with candidates that are remote. //Must be able to travel internationally on occasion. Travel hours is 50% of the ST rate.
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.).
Essential Duties and Responsibilities:
• Developing a medical writing curriculum for CERs and CER-related regulatory compliance documents to be used for training new medical writers
o Includes all bulleted documents above
o 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
o 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
• 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:
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
• 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 sessionsInterview platform: phone followed by onsite