Job Description
Must Have
Key Responsibilities:
• Perform day-to-day MICC activities in accordance with standard operating procedures (SOPs).
• Handle inbound and outbound calls/emails related to AEs, PCs, and MIs from patients, consumers, and healthcare professionals.
• Conduct timely follow-ups for MI/PC/AE queries to ensure complete and accurate information collection.
• Update, review, and maintain all process trackers (e.g., call logs, reconciliations) and SharePoint records accurately and on time.
• Participate actively in stakeholder meetings and cross-functional discussions.
• Stay up-to-date and compliant with internal guidelines and regulatory procedures.
• Organize and delegate tasks effectively to ensure timely and accurate completion of work.
• Demonstrate a high standard of work quality with minimal rework, ensuring deliverables are correct and complete.
• Complete all assigned tasks by the due date with 100% quality to meet client SLAs and internal metrics.
• Maintain training compliance and contribute to training delivery as required.
Qualifications:
• Bachelor’s degree in any “preferable in life science or something similar”
• Experience in call handling “preferable in Patient/HCP handling or something similar”
• Excellent communication skills and attention to detail.
• Proficiency in MS Office and SharePoint.
• Ability to work in a dynamic, deadline-driven environment.
**Prior experience in a U.S.-based call center environment is highly advantageous**
Good to have
• Broad area-2: Process Adherence and Compliance
o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy
o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client
o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms
o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines
• Broad Area-4: Self-Development
o Support in developing technical training programs for other team members relevant to the job
o Responsible to complete client-specific training, if applicable
o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas
EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc
EXPERIENCE: 2 to 4 years of Regulatory Writing
Key requirement:
• Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively
- Experience in document formatting
- Experience in literature search
• Good understanding of clinical trial and product life cycle
LOCATION: Bangalore (Office-based/Hybrid)