Sai Kumar Ella
Medical writer
Visakhapatnam
Summary
Self-motivated and detail-oriented medical writer with over four years of experience at Freyr Solutions, specializing in compiling and documenting reports. Known for a resourceful and tenacious approach to challenges, consistently delivering high-quality work in fast-paced environments. Seeking a full-time opportunity in medical writing or regulatory affairs within a progressive organization that fosters professional growth and aligns with career objectives. Committed to contributing expertise and dedication to drive impactful results in the healthcare industry.
Overview
4
4
years of professional experience
5
5
years of post-secondary education
Work History
Associate
Freyr Solutions
01.2022 - Current
- Compile and draft IVDR reports in line with the current In-Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746.
- Compile and draft the medical device reports in line with current medical device regulation (MDR) 2017/745.
- Good knowledge of end-to-end clinical documentation of reports such as CPR, CEP, CER, SSCP, PMPF Plan and Report, and PSUR.
- Acquiring knowledge on clinical documents, such as clinical study reports, informed consent, investigator brochures, etc.
- Extensive expertise in handling more than 50 IVD products for the creation of CPR, SVR, and APR documents, and 5+ CER, CEP, SSCP (cardiovascular devices, guidewires, software monitors, teeth straightening systems, balancing systems, and blood analyzers) on medical devices.
- Developing search strings specific to the database being used to yield precise, comprehensive data for the device under evaluation.
- Gather and analyze appropriate scientific literature applicable to the project.
- Sound knowledge of extracting and reviewing the relevant literature using scientific databases, pointing out inclusion and exclusion criteria, and screening relevant literature and contributions of results.
- Summarize the literature for relevant clinical data, review literature to elucidate the clinical problem and current treatment techniques, study and report device characteristics and instructions for use, and evaluate data for similar competitor devices.
- Appraise the articles according to the criteria given.
- Collate all sections (after receiving them from the Lead Medical Writer), add references, and format the document based on the decided formatting rules.
- Address comments and make necessary changes in the draft based on the Lead Medical Writer’s feedback.
- Creating checklists for performing gap assessments.
- Study and report device characteristics, instructions for use, and evaluate data for similar competitor devices.
- Proficient in developing search strategies for PubMed, Cochrane, Google Scholar, EMBASE, etc.
- Good knowledge of summary drafting for the reports, and reference management software Zotero.
- Able to address the feedback from clients to provide satisfactory reports.
- In addition, knowledge of APR, SVR, PMPF, PSUR reports, and compliant handling of medical devices, etc.
- Good knowledge of the documentation of the Post Market Surveillance Report (PMSR).
- Capable of meeting client expectations on project deliverables by efficiently gathering and analyzing data from various sources.
- Enhanced team productivity by streamlining communication and implementing efficient project management tools.
Education
Master of Sciences - Microbiology
Dr. Lankapalli Bullayya College
Visakhapatnam, Andhra Pradesh 07.2018 - 06.2020
Bachelor of Sciences - undefined
Prism Degree College
Visakhapatnam, Andhra Pradesh 08.2014 - 04.2017
Skills
Knowledge of EUMDR regulations
In-vitro diagnostic regulation
Proficient in SOTA methodologies
Performance Evaluation Report
Clinical Performance Report
Analytical Performance Report
Clinical Evaluation Report & Plan
Post Market Surveillance
Document preparation
Research expertise
Technical documentation
Decision-making
Effective time management
Disclaimer
I hereby declare that the above mentioned details are true to the best of my knowledge.
Publications
- Evaluation of Antimicrobial Activity of Excoecaria Agallocha L, IJTSRD, 4, 3, 04/2020, 190-192
- In Vitro Phytochemical Screening of Antimicrobial Activity of Sesuvium Portulacastrum (L.) and Suaeda Maritima L., EJPMR, 7, 11, 11/2020
Timeline
Associate
Freyr Solutions
01.2022 - Current
Master of Sciences - Microbiology
Dr. Lankapalli Bullayya College
07.2018 - 06.2020
Bachelor of Sciences - undefined
Prism Degree College
08.2014 - 04.2017