Manages preparation and submission of CTD, ACTD, and electronic dossiers. Leads eCTD publishing activities using Lorenz or similar publishing software. Coordinates module compilation across R&D, clinical, and manufacturing teams. Manages submission timelines and ensures on-time delivery of dossiers. Reviews compiled dossiers for completeness, format, and regulatory compliance. Manages responses to regulatory deficiency letters and authority queries. Maintains submissions tracking database and regulatory intelligence system. Coordinates with global affiliate teams for multi-country submission strategies. Ensures all submissions meet CDSCO, WHO, and ICH quality requirements. Supports preparation of major variation submissions for post-approval changes. Manages regulatory project plans and submission milestone tracking. Trains regulatory team members on eCTD, CTD structure, and submission processes. Stays current with CDSCO submission guidelines, eCTD updates, and IDMP standards.

Dispenses medications to inpatients, outpatients, and emergency department patients. Reviews prescriptions for drug interactions, dose appropriateness, and safety. Provides medication counseling and drug information to patients and caregivers. Manages pharmacy inventory and ensures adequate stock of all essential medicines. Coordinates with physicians for prescription clarification and therapeutic alternatives. Prepares IV admixtures, cytotoxic drugs, and TPN solutions in aseptic conditions. Monitors medication therapy for high-risk patients in ICU and critical care. Manages narcotic and controlled substance dispensing as per legal requirements. Conducts medication error reporting and participates in root cause analysis. Participates in hospital formulary management and drug policy committees. Supports clinical pharmacy services including antibiotic stewardship programs. Maintains records as per Drugs and Cosmetics Act and hospital standards. Stays updated with drug formularies, clinical guidelines, and pharmacy regulations.

Provides occupational health services to employees across industries. Conducts pre-employment and periodic medical examinations for workers. Diagnoses and manages occupational diseases and work-related injuries. Assesses fitness-for-duty for hazardous work environments. Develops workplace health and safety programs and policies. Conducts worksite inspections and health hazard assessments. Manages EAP (Employee Assistance Programs) and mental health support. Collaborates with safety officers and ergonomists on workplace risks. Prepares medical reports for insurance and compensation claims. Trains employees on occupational health and safety awareness. Ensures compliance with Factories Act and occupational health regulations. Participates in industrial hygiene monitoring programs. Manages vaccination and health surveillance programs for workers.

Diagnoses diseases through laboratory analysis of tissue and fluid samples. Performs histopathology, cytology, and autopsy examinations. Interprets bone marrow biopsies and haematological findings. Manages clinical laboratory operations and quality assurance. Oversees hematology, biochemistry, microbiology, and immunology labs. Validates and approves critical laboratory test results. Introduces new diagnostic tests and lab techniques. Collaborates with clinicians on diagnostic queries and reports. Ensures NABL accreditation compliance in laboratory operations. Manages reagent procurement and equipment maintenance. Trains laboratory technicians and pathology residents. Participates in MDT meetings and case conferences. Contributes to research and publishes scientific papers.

Position: Clinical Data Manager A distinguished opportunity awaits a seasoned Clinical Data Manager within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Key Deliverables and Responsibilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Develop SOPs, work instructions, and training materials for clinical operations teams. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Professional Requirements: Demonstrated teamwork skills and the ability to build trust and rapport across functions. 26 years of relevant industry experience with evidence of increasing responsibility. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.