Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables and statistical analysis. Proofreads, circulates, edits, assembles, inspects and duplicates product submissions. 3-5 years exp.
Will be working within the Cardiovascular and Structural Heart areas; doing clinical evaluations, plans, reports, summaries of safety and clinical performances; this job is focused on regulatory EUMDR.
The Medical Writer will support regulatory activities; will NOT be doing pamphlets, brochures, etc.
Successful Backgrounds:
People with clinical experience, 4 to 6 years of experience in this area or clinical studies and report writing within the Medical Device area.
Top Skills Required
Strong communicator both verbally and written,
Experience working within a Matrix Organization and Cross-Functional Teams,
Project Management experience where they owned their own projects and supported multiple technical projects,
MS Excel - Intermediate Level as they will leverage this as a tool to manage projects, data extracting, and screening, Word, and Technical Knowledge,
Citation Management Systems experience - they use Endnote but can come with other systems knowledge and experience and will train on theirs.
Education
A Bachelor’s Degree is required along with the 4 to 6 years of experience.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Staffing and Recruiting
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