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Clinical Specialist Medical Writing

5.00 to 10.00 Years   Pune   24 Mar, 2020
GLOINNT
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryCement / Building Material
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Write CERs by evaluating scientific literature, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data, and staying abreast of current clinical practice. Your effort and leadership support product approval, indication expansion, and mandated post - market requirements.
  • Provide clinical input to support claims and statements for new product development, post market surveillance, recertification, and business development.
  • Interact with regulatory agencies as needed, by providing audit support or addressing clinical queries in support of product safety and performance.
  • Manage CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
  • Provide input into hazard analyses, product failure modes & effects analyses, and directions for use for assessment of potential harms and support of product safety and performance.
  • Supports implementation of functional excellence initiatives.
  • Encourages problem - solving processes leading to leveragability of solutions across divisions.
  • Strong knowledge of medical terminology
  • Ability to review and synthesize medical publications and/or competitive product literature
  • Strong working knowledge of Adobe PDF, MS Word, and Excel
  • Ability to use in - depth clinical knowledge in cross functional team meetings
  • Understanding of information management (experience with relevant databases such as PubMed, Ovid, or Embase)
  • Experience with citation management software such as EndNote.
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Keyskills :
marketingnursing salesdatabase administration meeting facilitationnew product development post market surveillancefailure modes

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