Rani James
@ranijames
I turn complex clinical evidence into regulatory and medical content.
IndiaWhat I'm looking for
At Larsen & Toubro Technology Services, I develop and maintain Clinical Evaluation Reports and related medical-device documentation aligned with EU MDR 2017/745 and MEDDEV 2.7.1 Rev. 4.
I analyze clinical-trial, scientific-literature, and post-market data to create evidence-based conclusions. I also develop IFUs, ICFs, patient narratives, clinical summaries, and stakeholder slide decks.
Previously at DiponEd BioIntelligence, I prepared manuscripts, case reports, review articles, and educational content for online courses, conferences, and seminars. My work translates complex scientific and clinical data into clear, structured communication.
With a PhD in Biochemistry and 12 published papers, I bring more than 10 years of scientific and medical writing experience across clinical research, publications, and regulatory content.
Experience
Work history, roles, and key accomplishments
Project Lead (Integrated Content Management)
May 2020 - Present (6 years 4 months)
Developed and maintained Clinical Evaluation Reports (CERs) in compliance with EU MDR 2017/745 and MEDDEV 2.7.1 Rev. 4. Analyzed clinical data and created IFUs, ICFs, patient narratives, and clinical summaries.
Senior Scientist I
DiponEd BioIntelligence
Nov 2015 - Apr 2019 (3 years 5 months)
Developed and formatted research manuscripts, case reports, and review articles for peer-reviewed journals. Created scientific content for online courses, conferences, and seminars.
Scientist I
Avesthagen Limited
Jun 2015 - Oct 2015 (4 months)
Assisted in grant proposal development for national and international research funding.
Education
Degrees, certifications, and relevant coursework
Rajiv Gandhi University of Health Sciences
PhD, Biochemistry
2008 - 2014
PhD in Biochemistry with thesis on prognostic significance of VEGF polymorphism in breast cancer.
Cochin University of Science and Technology
M.Sc., Biotechnology
2001 - 2003
Grade: First Class (CGPA: 7.95/10)
M.Sc. in Biotechnology, passed in First Class with CGPA 7.95/10.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Salary expectations
Job categories
Skills
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