Janu L Ahmed

Objective: Strategically manage cancer screening programs, ensuring timely delivery, quality assurance, and patient satisfaction

Key Responsibilities:

• Project Management: Led and coordinated complex cancer screening initiatives, ensuring timely execution and achieving key performance indicators
• Patient Education and Outreach: Developed and implemented strategies to educate the patient/community about the importance of cancer screening, organized outreach events, distribute educational materials, and collaborate with department of health, regulators and community organizations to increase participation rates
• Data Management and Analysis: Collected, analyzed, and interpreted patient data to identify trends and inform strategic decision-making
• Quality Assurance: Implemented robust quality assurance protocols to maintain high standards of care and regulatory compliance. Conducted audits, review program protocols, and participate in quality improvement initiatives
• Collaboration and Communication: Worked closely with regulators, government agencies, healthcare providers, administrators, and community stakeholders to enhance program effectiveness. Maintained clear communication channels to facilitate coordination and support
• Training and Education: Provide training to healthcare staff on screening protocols, patient communication techniques, and use of screening tools to ensure consistent and effective service delivery
• Representative for Regulatory and External Hospital Audits: I excelled in representing the department during regulatory and external hospital audits, ensuring adherence to strict standards and regulatory requirements. I efficiently coordinate audit processes, maintain thorough documentation, and address findings promptly to support continuous operational improvement and compliance excellence

• Compile, review, and submit ANDAs in e-CTD format to USFDA via ESG
• Review analytical documents, sterility assurance packages, batch manufacturing, and packing records related to ANDA submissions
• Prepare and review protocols and reports for reconstitution studies and stability studies
• Respond to Agency queries regarding submissions and filings
• Develop new guidelines and periodically review existing Regulatory Affairs (RA) guidelines
• Coordinate with departments such as Formulation Development, Quality Assurance, and Analytical Development to ensure timely availability of data
• File supplements to FDA and conduct seminars on FDA-approved products for various departments to update them on available products and technologies
• Conduct orientation and training sessions for trainees on workflow, safety precautions, and industrial technologies
• Prepare annual reports and PSUR reports for approved ANDAs in the US market, as well as post-approval documents like supplements and PAS
• Manage market complaints for approved products and review Patient Information Leaflets (PIL) in SPL format
• Initiate change controls for dossier submission requirements. Review and approve change controls, specifications, and artworks
• Used strong issue resolution and communication skills to cultivate and strengthen lasting client relationships.
• Coordinate with staff to enhance service quality and ensure adherence to turnaround time (TAT). Monitor team members' progress towards achieving targets

• Adjudicate and process bills/claims received from medical providers & policy holders in accordance with medical provider’s contracts & policy coverage respectively in an accurate & timely manner
• Scrutinize the provided medical documents as per the claim management guidelines
• Handled both direct billing and re-imbursement claims
• Recommend accept/reject insurance coverage within limits set in the underwriting medical policy
• Interact with Insurance companies and sort out issues concerning rejection of claims
• Provide presentations to the corporate with regard to Insurance benefits and process flow to be exercised
• Conduct training classes related to Policy Provisions and exclusions as per policy guidelines to the new trainees
• Interact with Hospitals and Customers and clarify their doubts with regards to medical queries raised while processing the claims