Leads physicochemical and biological characterization of biosimilar candidates. Conducts analytical similarity assessment per FDA and EMA biosimilar guidelines. Develops and validates analytical methods for biologic characterization. Manages upstream and downstream process development for biosimilar proteins. Prepares comparability study protocols and reports for regulatory submissions. Supports clinical pharmacology and PK/PD studies for biosimilar programs. Coordinates with CMOs for biologic drug substance manufacturing activities. Prepares Module 3 sections of biosimilar regulatory dossiers. Manages reference product sourcing and characterization studies. Coordinates with clinical and regulatory teams on biosimilar development strategy. Evaluates immunogenicity assessment strategies for biosimilar programs. Supports FDA and EMA pre-submission meetings for biosimilar development questions. Stays current with ICH Q5A-E guidelines, FDA/EMA biosimilar guidances, and case studies.

Collects, processes, and evaluates individual case safety reports (ICSRs). Performs medical coding of adverse events using MedDRA terminology. Prepares and submits expedited and periodic safety reports to authorities. Conducts literature searches for adverse event identification and assessment. Reviews patient narratives for completeness, accuracy, and medical consistency. Manages safety database (Argus, ARISg) and ensures data entry accuracy. Coordinates with clinical, medical affairs, and regulatory teams on safety matters. Prepares Periodic Benefit Risk Evaluation Reports (PBRER/PSUR) per ICH E2C. Supports signal detection and risk management plan activities. Conducts training for field force on adverse event identification and reporting. Assists with preparation for regulatory pharmacovigilance inspections. Manages case reconciliation with CROs, partners, and marketing subsidiaries. Stays updated with ICH E2A-E2F guidelines and CDSCO PV regulations.

Installs, maintains, and repairs complex medical equipment and devices. Manages preventive maintenance schedules for hospital medical equipment. Troubleshoots and resolves technical faults in biomedical systems. Ensures compliance with AERB and CDSCO equipment regulations. Manages equipment inventory and asset tracking systems. Coordinates with medical equipment vendors for service contracts. Evaluates new biomedical equipment for hospital procurement decisions. Ensures calibration of diagnostic and therapeutic equipment. Trains clinical staff on safe and effective equipment operation. Manages equipment lifecycle planning and capital expenditure. Develops SOPs for equipment management and safety protocols. Participates in facility expansion and equipment installation projects. Prepares equipment downtime and maintenance performance reports.

Position: Project Manager I (Clinical Research), Division of General Internal Medicine Our organisation invites applications from accomplished professionals for the role of Project Manager I (Clinical Research), Division of General Internal Medicine. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Role Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Provide clinical site training on data collection standards and regulatory requirements. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Education and Experience Requirements: A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Minimum 35 years of progressive professional experience in a comparable role. Excellent verbal and written communication skills; fluency in English is essential. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.

Position: Clinical Data Manager Our organisation is looking for an ambitious Clinical Data Manager committed to quality outcomes and sustained growth. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Main Accountabilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Review source data and ensure completeness, accuracy, and regulatory compliance. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Essential Skills and Experience: Strong project management capabilities with experience in agile or structured methodologies. Superior writing and communication skills with experience preparing executive-level documents. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Collaborative, proactive, and able to operate effectively with minimal supervision. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.