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0-2 years
10000 INR
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Officer - FDA
Department: US FDA Regulation
Location: Remote


Purpose of Document

This document serves to outline the working pattern and job requirements for home-based regulatory consulting services. It also provides a clear understanding of employee commitment and willingness to meet the company's expectations.

Compensation & Terms

  • Monthly Pay: 10,000 INR (for the first 2 months)
  • Tax: Tax Deducted at Source (TDS) as per India Government Rules.
  • Working Days: Monday to Friday (5 days a week)
  • Work Timing: 0900 - 1800 (8 hours per day, 40 hours per week)
  • Online Punch-In and Punch-Out: Mandatory, with computer monitoring during login period.
  • Attendance: Professional fee based on time and attendance. Absence of four consecutive days will be considered leave, and the fee for that period will be deducted.

Employee Responsibilities

  1. Work Hours Flexibility:
    • 1.30 hours early login and 1.30 hours late logout allowed to make up for lost time.
    • Make-up for lost work days/hours can be done on Saturdays with manager approval.
  2. Communication:
    • Be available on Cliq, mobile, WhatsApp, and email after punch-in.
    • Respond to all incoming calls from clients and team members on working days and Saturdays.
    • Maintain a consistent contact number throughout the tenure.
    • Use only domain-linked email for communication.
    • Communicate all critical matters through email. Internal communication via Cliq, WhatsApp, and Outlook only.
  3. Technical Documentation:
    • Review and develop technical documentation for various regulations (e.g., UK, EU, USA).
    • Guide manufacturers on FDA regulations, 510K, and drug registrations with precision.
    • Draft emails with careful attention to detail, avoiding spelling and grammar mistakes.
  4. Meetings & Behavior:
    • Attend online meetings with domestic and international clients, irrespective of time zones.
    • Always communicate in a pleasant and courteous manner during online meetings.
    • Ensure appropriate dress and a quiet background during meetings.
  5. Equipment and Environment:
    • Use a computer with Windows 10, i5 processor, Office 2016, SSD storage, quality microphone, and camera.
    • Ensure internet speed of at least 6 Mbps upload speed.
    • Develop all documents in the cloud and regularly scan for antivirus safety.
    • Avoid unwanted programs that affect computer performance.
  6. Travel & Availability:
    • Willingness to travel to the Bangalore office for training and annual meetings.
  7. Leaves and Resignation:
    • Inform about proposed leaves in advance.
    • Provide at least 45 days' notice for career change or resignation.
    • Resign voluntarily if unable to meet work requirements due to home disruption or time management issues.

Job Expectations

  • Complete projects on time based on project planning.
  • Report to Team Lead and Project Head.
  • Any failure to meet job duties, frequent absences, low-quality work, or poor time management may result in termination.

Commitment

  • Employees must be willing to commit to working with I3CGLOBAL for a minimum of 3 years from the date of joining, considering their family circumstances.