Manages end-to-end supply chain operations for pharmaceutical products. Develops demand forecasting models using historical data and market trends. Coordinates with manufacturing, procurement, and logistics teams for supply. Manages inventory levels across warehouses, depots, and C&F agents. Ensures product availability at stockists to prevent stockouts and shortages. Manages cold chain logistics for temperature-sensitive pharmaceutical products. Coordinates import and export activities for API, excipients, and finished goods. Implements S&OP (Sales and Operations Planning) processes for the business. Tracks supply chain KPIs including fill rate, OTIF, and inventory turns. Manages ERP system data integrity and supply chain module configurations. Develops contingency plans for supply disruptions and raw material shortages. Ensures compliance with GDP guidelines for pharmaceutical product distribution. Stays current with pharma supply chain regulations, serialization, and track-and-trace.

Serves as the scientific link between the company and healthcare professionals. Establishes and maintains peer-to-peer relationships with key opinion leaders. Provides balanced and evidence-based scientific information to physicians. Supports investigator-initiated studies (IIS) and manages grant applications. Presents clinical data, trial results, and product information at medical events. Contributes to advisory board meetings and scientific conference planning. Collects field medical insights and shares with cross-functional teams. Supports pre-launch medical education activities for new product introductions. Coordinates publication planning and co-authors scientific manuscripts. Provides reactive medical information responses to complex scientific queries. Trains field force on scientific data and clinical evidence for products. Manages relationships with academic institutions and teaching hospitals. Stays updated with clinical guidelines, disease literature, and evidence synthesis.

Designs clinical databases and CRFs for Phase I to III clinical trials. Develops data management plans, data validation plans, and edit check specifications. Manages data entry, query management, and data cleaning across study sites. Conducts medical coding for adverse events and concomitant medications. Performs user acceptance testing for clinical database applications. Manages database lock activities and prepares data for statistical analysis. Ensures compliance with CDASH/CDISC standards for data collection and submission. Coordinates with CRO data management teams for outsourced trial operations. Prepares data management reports and presents to clinical project team. Maintains trial master file components related to data management activities. Ensures data integrity and audit trail compliance throughout the study. Supports regulatory inspections with data management documentation. Stays current with EDC platforms, CDISC updates, and data governance regulations.

Designs statistical analysis plans for Phase I, II, and III clinical trials. Performs statistical analysis of clinical trial data using SAS or R software. Prepares statistical outputs including tables, figures, and listings (TFLs). Reviews and validates clinical data for statistical consistency and accuracy. Supports sample size calculations and randomization schedules for trials. Contributes statistical sections to clinical study reports and regulatory submissions. Collaborates with data management teams on database lock and data review. Provides statistical input for protocol design and study feasibility assessments. Develops statistical specifications for programming and validation activities. Reviews and approves SAS programs used for regulatory submission outputs. Supports adaptive trial design and interim analysis planning. Provides biostatistical training and guidance to junior statisticians. Stays updated with FDA statistical guidelines, ICH E9 R1, and estimand framework.

Conducts target identification and validation studies for new drug candidates. Designs and synthesizes new chemical entities using medicinal chemistry principles. Performs structure-activity relationship (SAR) studies to optimize drug candidates. Conducts in-vitro biological screening assays for activity and selectivity. Collaborates with computational chemistry teams for molecular modelling work. Evaluates ADMET properties of drug candidates using in-vitro assays. Prepares scientific reports and publications for internal and external communication. Supports intellectual property filing and patent documentation. Manages compound libraries and chemical inventory in research databases. Coordinates with pharmacology teams for in-vivo animal model studies. Presents research progress at internal and external scientific forums. Ensures safe handling of chemical substances and compliance with lab safety. Stays current with medicinal chemistry literature, disease biology, and drug design.

Develops and optimizes manufacturing processes for pharmaceutical drug products. Conducts process characterization studies using statistical and risk-based tools. Scales up formulations from laboratory to pilot and commercial manufacturing scale. Develops process validation protocols, reports, and process control strategies. Applies Quality by Design (QbD) principles in process development activities. Identifies critical quality attributes (CQAs) and critical process parameters (CPPs). Uses design of experiments (DoE) to optimize processing conditions systematically. Supports technology transfer by preparing process descriptions and batch records. Investigates manufacturing failures and recommends process improvements. Collaborates with analytical development and QA teams on product development. Prepares CMC sections for ANDA/NDA regulatory submissions. Manages pilot plant and manufacturing scale equipment qualification activities. Stays updated with ICH Q8, Q9, Q10, Q11 guidelines and validation guidance.

Provides overall leadership and accountability for all plant operations. Ensures manufacturing, quality, and EHS compliance at the plant site. Develops plant operating plans aligned with corporate business objectives. Manages P&L, capital expenditure, and operational cost budgets for the plant. Leads regulatory inspections including US-FDA, EU-GMP, and WHO audits. Drives continuous improvement, operational excellence, and lean initiatives. Manages relationships with corporate teams, customers, and regulatory authorities. Oversees talent management, succession planning, and leadership development. Drives technology upgrades, capacity expansions, and new product introductions. Ensures environmental compliance and occupational health and safety standards. Reviews and approves critical quality and operational decisions for the plant. Prepares annual plant performance reviews and presents to senior management. Stays current with industry benchmarks, regulatory changes, and pharma manufacturing trends.

Manages day-to-day manufacturing operations for oral solid dosage forms or injectables. Oversees production planning, scheduling, and adherence to production targets. Ensures GMP compliance across all production activities and areas. Reviews and approves batch manufacturing records and deviation reports. Leads investigation of production failures, deviations, and OOS results. Manages manufacturing team performance, training, and development activities. Coordinates with QA, QC, planning, engineering, and procurement teams. Oversees validation and qualification activities for equipment and processes. Monitors production KPIs and identifies opportunities for efficiency improvement. Prepares capacity utilization reports and production budget management. Manages interactions with regulatory authority inspection teams during audits. Ensures 5S, EHS, and housekeeping standards are maintained consistently. Stays current with GMP regulations, FDA warning letters, and industry best practices.

Operates and monitors pharmaceutical manufacturing equipment and processes. Executes batch manufacturing as per batch manufacturing records and SOPs. Ensures compliance with GMP guidelines during all manufacturing operations. Performs in-process checks and records data accurately in production records. Coordinates with planning team for scheduling batch production activities. Manages housekeeping, cleanliness, and 5S standards in production areas. Reports equipment breakdowns and follows up with engineering for repairs. Assists in process validations and equipment qualification activities. Participates in deviation investigations and CAPA implementation. Ensures proper gowning, hygiene, and personnel behavior in production areas. Monitors material reconciliation and ensures no mix-up or contamination. Conducts line clearance and document checks before each batch production. Stays updated with Schedule M, WHO-GMP, and current GMP guidelines.

Evaluates adverse drug reaction reports from multiple data sources globally. Performs benefit-risk assessment for drugs in the company's portfolio. Leads signal detection activities using statistical and qualitative methods. Prepares and reviews Risk Management Plans (RMPs) for regulatory submissions. Manages SUSAR reporting timelines and ensures compliance with global regulations. Supports preparation of PBRER, DSUR, and annual safety reports. Reviews protocols and informed consent forms for safety-related considerations. Maintains pharmacovigilance system master file (PSMF) documentation. Coordinates with global safety team and affiliates on safety communications. Manages safety data exchange agreements with partners and licensees. Conducts pharmacovigilance training for internal and external stakeholders. Supports regulatory authority queries on safety matters for marketed products. Stays current with EMA, FDA, CDSCO pharmacovigilance regulations and guidance.