Designs and oversees Phase I clinical pharmacology studies for drug programs. Develops clinical pharmacology sections for IND and NDA regulatory filings. Manages first-in-human studies including dose escalation and safety assessments. Designs drug-drug interaction studies and interprets PK/PD interaction data. Conducts food effect, renal impairment, and hepatic impairment study designs. Reviews clinical PK data and prepares population PK model analysis plans. Provides clinical pharmacology input to dose selection and regimen decisions. Supports FDA and CDSCO submissions with clinical pharmacology data packages. Leads clinical pharmacology sections of integrated summaries for NDA submissions. Coordinates with biostatistics and data management for clinical PK studies. Reviews bioequivalence data and prepares regulatory assessments for ANDAs. Provides scientific guidance on pediatric and special population study designs. Stays updated with FDA Guidance, EMA guidelines, and clinical pharmacology advances.

Manages international product management for assigned markets and portfolios. Develops market entry strategies for regulated and semi-regulated markets. Coordinates regulatory submissions for product approvals in export markets. Manages relationships with international distribution partners and licensees. Monitors international market performance and prepares business reports. Coordinates with supply chain for export dispatch and shipment schedules. Manages product artwork updates for international market requirements. Conducts market research and competitive analysis for export markets. Supports preparation of export tenders and government procurement bids. Coordinates with legal for international agreements and contract management. Manages customer complaints and product recall processes in export markets. Prepares business development proposals for new market expansion opportunities. Stays updated with international regulatory requirements and trade regulations.

Promotes and sells medical devices to hospitals, surgeons, and procurement. Conducts product demonstrations and in-service training for clinical staff. Provides technical support during surgical procedures as required. Achieves territory sales targets for device portfolio. Builds and maintains relationships with key surgeons and hospital administrators. Manages tender submissions and hospital formulary inclusions. Monitors competitive device landscape and adjusts sales strategies. Collects and reports adverse events and product complaints to vigilance team. Coordinates with clinical and marketing teams for product launches. Conducts clinical education sessions and CMEs for physician customers. Manages consignment inventory and instrument set management. Prepares monthly territory performance reports for management. Ensures ethical promotion aligned with MDR 2017 requirements.

Provides primary healthcare consultations to patients across all age groups. Diagnoses and treats common illnesses, infections, and chronic conditions. Orders and interprets diagnostic tests including blood work and imaging. Prescribes appropriate medications and monitors patient response. Refers patients to specialists when complex conditions are identified. Maintains accurate and detailed patient medical records. Participates in outpatient and inpatient care as assigned. Counsels patients on preventive healthcare and lifestyle modifications. Collaborates with nurses and paramedical staff for comprehensive care. Adheres to ethical medical practice and MCI/NMC guidelines. Participates in continuing medical education and case discussions. Manages medical emergencies with timely and effective interventions. Ensures patient confidentiality and informed consent practices.

Position: Clinical Data Manager A dynamic organisation seeks an experienced Clinical Data Manager to take on a multifaceted and impactful role. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Principal Responsibilities: Provide clinical site training on data collection standards and regulatory requirements. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Review source data and ensure completeness, accuracy, and regulatory compliance. Candidate Requirements: 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Sound understanding of organisational dynamics and stakeholder management in complex environments. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.