Clinical Specialist – Medical Writing Job Vacancy in GLOINNT Pune, Maharashtra – Updated today
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Company Name : GLOINNT
Location : Pune, Maharashtra
Position :
Job Description : Role: Clinical Specialist
Qualification: Bachelor’s degree and 5+ years of related work experience (Clinical Risk/ Safety/ Trial/ Medical Writing).
Experience: 5+ years
Location: Pune
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.
Interested candidates can contact us on +91-XXXXXXXXXX/9353556010 and kindly share your resume to hr@gloinnt.com.
This post is listed Under Healthcare
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