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Medical Writer (CER Specialist) – Medical Device (Celegence Systems Private Limited)

  • Medical Writer
  • Full time
  • 1 month ago
  • Banglore

Job Information

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    Salary Not Disclosed Not Disclosed / Not Disclosed
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    Shift Morning
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    No. of Openings 5 openings
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    Job Level : junior
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    Job Experience : 3-8 Years
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    Job Qualifications bachelors or above

Job Description

Company Name: Celegence Systems Private Limited

Designation: Medical Writer (CER Specialist) – Medical Device

Location: Bangalore/Bengaluru( Bannerghatta Road )

Experience: 3 – 8 years

Qualification: UG :B.Sc in Any Specialization, B.Pharma in Any Specialization, B.U.M.S in Any Specialization, Other Graduate, MBBS in Any Specialization, BAMS in Any Specialization, BHMS in Any Specialization

Job Description: Roles & Responsibilities:

  • Ensure on-time development and delivery of high-quality CERs compliant with MEDDEV 2.7/1 Rev. 4. And EU MDR for devices across therapeutic areas
  • Be adept at delivering solutions that are customized per the client requirements
  • Assist in the development of schedules to ensure client CER timelines are met
  • Perform literature searches, screen and summarize literature for relevant clinical evidence
  • Study device-specific client documents and report device characteristics and instructions for use
  • Summarize data from post-marketing surveillance and perform risk analysis for the devices in scope
  • Actively engage with cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process
  • Work with the team and Team Lead to prepare documents that meet client expectations in terms of content, format, and presentation
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.

Desired Candidate Profile

  • Bachelors Degree / Post Graduation in any relevant Life Sciences fields. Masters Degree is preferred.
  • RAC certification is a plus
  • Minimum 3 years of relevant CER experience required
  • Familiar with the Life Sciences Industry, preferably Regulatory Services
  • Hands on experience on CER to perform their job role.
  • Experience in creating customer facing materials
  • Ability to work independently
  • Fluent in English

Technical / Functional Skills:

  • Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation
  • Experience in Literature Search, Review and Analysis, Risk Benefit Assessment, Equivalency Approach, Post Market Surveillance Data Analysis including Trend CER Analysis, Non-Clinical/Clinical Data (pre-clinical, Sponsored studies/IIR), State of the Art (SotA) and Conclusions.
  • Experience in performing medical literature searches (PubMed, Google Scholar, etc.)
  • Hands on experience on presentation tools like PowerPoint, Visio etc. will be an added advantage.

Salary: Not disclosed

Address: IndiQube – Subramanya Arcade, Ground Floor- Tower D, Municipal No.12, Bannerghatta Main Rd, Old Gurappanapalya, Bengaluru, Karnataka 560029

Website Link: https://www.celegence.com/careers/

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