Yogesh Kumar Nangia
Project Lead- Medical Documentation
Bangalore
Summary
PROFILE SUMMARY: Doctor of Philosophy with nearly 14 years of comprehensive experience in research and development and operations management in the biotech, biopharma, medical devices and in vitro diagnostics industries. Successfully executed research projects involving planning, execution application of methodologies. Proficient in analyzing and interpreting research results and technical data; possess expertise in method development ad documentation. Adept in prioritizing significant work load while consistently meeting project deadlines; rich experience in working within a group with people of diverse technical and cultural background while demonstrating leadership quality. Result-focused team player with excellent written & verbal communication skills and strong analytical, problem solving and organizational abilities; possess a flexible and detail oriented attitude.
Overview
14
14
years of professional experience
2
2
Languages
Work History
Project Lead- Medical Documentation
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
Bangalore
08.2022 - Current
- Led team of engineers in providing quality documents required for CE marking after Brexit.
- Maintained timelines to keep teams on task and achieve schedule targets.
- Provided team with coaching and direction.
- Partnered with project team members to identify and quickly address problems.
- Developed and trained junior team members by leveraging industry experience to achieve optimal project strategy.
- Updated customers and senior leaders on progress and roadblocks.
Reviewer- Medical Documentation
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
Bangalore
07.2022 - 08.2022
- Reviewed medical documents (Device verification summary report (DVSR), Intentional Use Documents (IUD) Risk Management Documents (RMR) before submission to the client (a medical device company).
- Managed competing deadlines with efficiency.
- Consulted with documents authors to eliminate any errors.
- Maintain good Understanding of packaging, labeling, sterilization, biocompatibility and medical device standards.
Medical Safety Associate
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
Bangalore
05.2022 - 06.2022
- Create / Update Design History File (DHF) documents such as Design Verification and Design Validation (V&V) summary report (DVSR) and intentional use documents (IUD)/
- Maintain good Understanding of packaging, labeling, sterilization, biocompatibility and medical device standards.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Worked flexible hours across night, weekend and holiday shifts.
Medical Writer/ Consultant
PAREXEL International India (P) Ltd
Chandigarh
02.2018 - 01.2022
- Combined thorough understanding of therapeutic area with product strategy to meet communication objectives on assigned projects such as signal assessment, signal validation, periodic benefit-risk evaluation reports (PBRERs).
- Interpreted and synthesized large amounts of scientific data to create compelling messaging, scientific stories and narratives that aligned with client business goals.
- Engaged with key opinion leaders and clinical trial investigators to author documents.
- Reviewed projects for scientific accuracy to align with project brief and incorporate internal and client or author feedback.
- Gained trust and established connections with clients beyond projects to obtain repeat business and widen existing scope and services.
- Proofread copy written by colleagues to correct spelling, punctuation and grammar.
- Participated in team-building activities to enhance working relationships.
Director
Nangia Nanolab (P) Ltd
Bhopal
11.2014 - 10.2017
- Oversaw operations and provided corrective feedback to achieve daily and long-term goals.
- Delivered innovative solutions and services to the clients from a variety of sectors in pharmaceutical, med-tech, other life science sectors and nanotechnology
- Provided R&D support to biotech companies
- Prepared project proposals and drafted patents.
Senior/ Junior Research Fellow
Institute of Microbial Technology
Chandigarh
02.2008 - 09.2014
- Followed best practices and scientific protocol to reach defensible conclusions based on solid evidence.
- Recorded data from research to allow for accurate analysis.
- Authored professional scientific papers for publishing in peer-reviewed journals.
- Worked in a Biosensor laboratory, studying electrochemical, Flouroscence based and optical assay/methods on small molecules, proteins and carbohydrates.
- Performed scientific research on multiple projects.
- Conducted and evaluated research using cutting-edge technology.
- Supported and supervised students in Biosensor research programs from brainstorming areas for potential research through publishing papers on completed projects.
Education
Ph.D -
Jawaharlal Nehru University
M.Sc. - Biotechnology
Barkatullah University
B.Sc. - Biotechnology
Devi Ahilya University
Skills
Project leadership
Timeline
Project Lead- Medical Documentation
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
08.2022 - Current
Reviewer- Medical Documentation
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
07.2022 - 08.2022
Medical Safety Associate
L&T Technology Services (On payroll of third party IDEXCEL Technologies Pvt Ltd)
05.2022 - 06.2022
Medical Writer/ Consultant
PAREXEL International India (P) Ltd
02.2018 - 01.2022
Director
Nangia Nanolab (P) Ltd
11.2014 - 10.2017
Senior/ Junior Research Fellow
Institute of Microbial Technology
02.2008 - 09.2014
Ph.D -
Jawaharlal Nehru University
M.Sc. - Biotechnology
Barkatullah University
B.Sc. - Biotechnology
Devi Ahilya University
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