Medical Device Medical Writer (CER Specialist) – India
Celegence is seeking a Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The consultant will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.
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.
Education & Experience
- Bachelor’s Degree / Post Graduation in any relevant Life Sciences fields. Master’s Degree is preferred.
- RAC certification is a plus
- Minimum 2 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
Skills and Competencies
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.
- Possess strong verbal and written communications skills, interpersonal skills, strategic thinking, ability to influence others & problem resolving skills
- Client focused approach to work
- Ability to prioritize and manage multiple projects
- Excellent Communication (Writing and Verbal)
- Customer Focused
- Organization Skills
- Drive to deliver superior quality proposals
- Strong Time management
- Good Stakeholder management
- Positive Attitude
- Initiative and Commitment
- Detailed Oriented
- Team player
- Focused and sincere
Please make sure you have the relevant work visa prior to applying