Tata Elxsi is amongst the world’s leading providers of design and technology services across industries including Automotive, Broadcast, Communications, Healthcare, and Transportation. Tata Elxsi is helping customers reimagine their products and services through design thinking and the application of digital technologies such as IoT (Internet of Things), Cloud, Mobility, Virtual Reality, and Artificial Intelligence.
Post : Medical Writer / Senior Medical Writer
Job Description
- Author and conduct medical and technical writing of clinical evaluation reports (CERs) in support of compliance to EU MDR- Med Dev 2.7, rev 4 for devices across therapeutic areas
- Author and review post-market clinical follow up (PMCF) plan and PMCF reports
- Summarize post-marketing surveillance and risk management data for the target device
- Work cross-functionally to ensure adherence to submission and company-driven deadlines
- Collaborate with stakeholders and participate in client calls and supporting work stream leaders
- Providing product guidance and expertise to conduct literature searches on products/product families
- Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
- Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities
- Exemplary knowledge of clinical evaluation processes and medical device development
- Strong, concise scientific style of writing with a high level of attention to detail
- Ability to function well as a member of the team and build relationships between Clinical Affairs and other areas of the organization
- Intermediate computer skills, including Microsoft Office Suite
- Ability to lead a team and influence others
- Proficient knowledge of EU regulations (MDR/MDD) and regulations outside of the EU Education / Experience Requirements
Candidate Profile
- BE / B.Tech in Biomedical Engineering / B.Pharm / M.Pharm / MBBS / BHMS / BAMS / BDS / Life Science background
- Masters or Bachelors degree in Biomedical, Medical, life sciences or related field preferred. Alternate degrees may be considered
- A minimum of 5-10 years of experience in handling projects pertaining to Clinical Affairs / Medical Writing (e.g. biomedical research, medical/regulatory/scientific writing, clinical trial management) required - Experience handling a team of Medical writers
- Effective communication skills
- Experience with client interactions
Additional Information
Experience : 5-10 years
Qualification : B. Pharm / M. Pharm/ MBBS /BHMS /BAMS /BDS/ Life Science
Location : Pune
Industry Type : Pharma / Healthcare / Clinical research
End Date : 31st January, 2023
Interested candidates can drop your cv to below mail Id palvai.u@tataelxsi.co.in
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