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/