Arul Sobin Simon Baby

Driven and talented Editor with 13 years of experience collaborating with others to deliver error free reports to the hospitals across US, UK, Australia and Canada. Expert at correcting sentence structure, grammar, spelling and punctuation by rewriting, editing and proofreading. Clear communicator, gives constructive feedback and specific suggestions to dramatically improve writing of staff. Proven history of exercising sound editorial judgment and maintaining deadlines. Superior writing skills with aptitude for guiding writers and contributors to deliver exceptional content and performance.

• Medical Transcription Certification, Doctnet Private Ltd.
• Undergoing Content Writing Certification course, Career Path Pvt Ltd

• Editing or Proof reading capability of over 100 records per shift with 99% accuracy. Transcribing capability of over 50 records per shift.
• Knowledge in medical terminology.
• Exposure to Multispecialty Reports like Discharge Summaries, Operative Reports, SOAP Reports, Radiology, Elderly Care, Psychiatry, General Surgery, Orthopaedics, Gastroenterology, Ophthalmology, Internal Medicine, Urology, Cardiology, and Lab & Clinical Reports.
• Knowledge of medical records maintenance.
• Knowledge of health care, anatomy, physiology with various medical specialties.
• Excellent keyboarding and auditory skills.
• Typing speed of 45-50 wpm.
• Ability to follow and implement instructions.

• As a Technical Lead, need to assign records from TrackWise for the team on a daily basis.
• Monitoring assigned complaints for actions to be taken within Turn Around Time so that there is no delay in filing MDR to FDA.
• Updating customer on Pharmaceutical and Medical Device Agency complaints (PMDA) on a daily basis
• Sending followup emails to field technician/hospitals if incomplete details are provided to file MDR to FDA.
• Updating device manufacturer on sample return complaints
• Allocating PMDA and sample return complaints to team members and tracking it to closure
• Responsible to track the high ageing complaints to closure and also close reportable complaints once MDR is filed to FDA and close nonreportable complaints once all child records are closed as part of 21 CFR part 803 regulatory compliance.
• Generate weekly status report and present it to program manager.
• Share weekly status report with customer on weekly basis on status meeting calls.
• Cascade new learnings to the team and take necessary steps to implement them on complaints processed by team
• Update the team on the feedbacks from customer on a daily basis and take actions to reduce the number of defects reported by customer

• Transcribing more than 50 records or editing/proof reading of 100 records transcribed by juniors or voice Voice Recognizing Software’s Medical Records.
• Auditing various multispecialty medical reports from vendors.
• Editor – Quality Analyst – Proof Reader (Medical Transcription).

Expecting reasonable salary for my experience and it is negotiable.

• Communicating and interacting with customer on a daily basis via e-mail and Teams calls
• Analyze and review complaints for CRM (customer relationship management)
• Make the team function smoothly and encourage them to finish all assigned tasks on a daily basis
• Updating the customer on daily a basis on the project status via Teams status call and interacting with customer on doubts and queries raised by team
• Presenting reports to senior management on team productivity, targets met, pending tasks on twice a month basis
• Presenting dashboard (complaints received, processed, EMDR submitted) on Weekly Status Review meeting
• Updating KPP for team members
• Conducting weekly DPA meetings and communicating to other work streams on the errors committed and discuss on preventive measures.
• Support audit related activities (for ISO13485 MD-QMS audit and Supplier audit)

• Father's Name: Simon
• Notice Period: Three months.
• Date of Birth: 10/13/1981
• Gender: Male
• Nationality: Indian
• Marital Status: Married

(+91) 7708324365

• English
• Tamil
• Malayalam

I hereby declare that the information furnished above is true to the best of my knowledge.

• Young Talent award for the year 2022 by Beckton Dickinson and Company
• Whitepaper on "Medical Device Complaints Handling for USA"
• IPRB - Generated a problem statement for Infusion pump product (Problem - air bubbles leaking into blood vessels)