Responsibilities Clinical Requirement Gathering: Attend clinical meetings and interact with clinicians to understand and gather their clinical requirements for product development. Ensuring Clinical Quality: Review data provided by Clinical Data Engineering and AI Research Teams at all stages of product development for clinical accuracy. Ensure the final product meets the precise clinical requirements. Provide clinical strategy: Understand clinical aspects, design and development of AI technologies, and principles of medical device development to provide a clinical strategy to help in technology and product development. Ensuring clinical competency of internal teams: Research, interpret, and summarize published medical/scientific literature/clinical guidelines. Prepare internal training materials, documentation, protocols, and SOPs to ensure the clinical competency of teams involved at various stages of product development.     Qualification & Experience B.E or B.Tech in Biomedical Engineering / Biotechnology / B.Sc in biological sciences 2 to 3 years of experience in an ultrasound application specialist role demonstrating expertise in ultrasound machine handling and radiology applications. Ability to read, understand, and interpret ultrasound data, including images, video loops, and reports.  

Responsibilities Ensuring clinical quality and integrity of medical data: Support in preparation of medical image annotation for training and validation of AI algorithms Review medical data provided by Clinical Data Engineering and AI Research Teams at all stages of product development for clinical accuracy. Ensure the final product meets the precise clinical requirements. Provide clinical strategy: Understand clinical aspects, the design and development of AI technologies, and the principles of medical device development to provide a clinical strategy to help in technology and product development. Provide clinical strategy: Understand clinical aspects, the design and development of AI technologies, and the principles of medical device development to provide a clinical strategy to help in technology and product development.   Qualification & Experience Bachelor of Medicine and Bachelor of Surgery (MBBS) Degree with DNB/MD in Obstetrics/Gynaecology OR Radiology At least 2-5 years of experience with Fetal Imaging Data-driven with the ability to analyze and extract clinical insights to support decision-making.  

Responsibilities Develop, implement and maintain policies, local procedures and tools to achieve a consisitent risk based approach to computer system validation and Administration of Quality and R& D systems. Develop and implement 21 CFR Part 11 and any other related regulatory compliance strategy for new and existing systems, including remediation of legacy systems. Represent the regulatory inspections with respect to computer system validation, GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Participate as an Subject Matter Expert for computerized system validation and IT Compliance. Participate in projects,investigations, audits and improvement initiatives. Devise strategies and Lead CSVC and GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Setup operation processes for sustaining compliance and service delivery of GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions. Collaboration with Global CSVC and IS teams to harmonize CSVC and IS policies,procedures, processes across Apotex. Monitor, audit and assess department performance vs business objectives to implement improvements, determine continued relevance and anticipate opportunities. Ensure adherence of team members with all compliance programs and company policies and procedures. Ensure the computerized system validations and documentation as per GDP and QMS. Ensure Site & Global SOP’s shall be followed during Computer system validations and Administration GIS Quality and R& D systems, Audit & IT Compliance and Mfg Platform Solutions compliance as applicable. Review and Approve of documents in GIS. Follow QMS process in trackwise as per applicable SOP. Predictive compliance activities like review of regulatory guidance’s, regulatory observations etc. Maintain effective inter-personal relationship with Cross-functional department personnel. Work as Team member to achieve Goals and objectives of department. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion. Performs all work in accordance with all established regulatory and compliance and safety requirements. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures,Safety and Environment policies and HR policies. All other duties as assigned by Superior.     Qualification & Experience A minimum university graduate in BE/ B. Pharm / M Pharm / M. Sc. Knowledge, Skills and Abilities Knowledge on CSV, Quality and R& D systemss, 21 CFR Part 11 and EU Annex 11. Knowledge on ICH Q7, GMP, and GAMP guidelines. Team work and collaborative skills. Proficient in verbal & written communication skills. Minimum 12 years of experience in GMP regulated Pharmaceutical Industry. Minimum 8 years of experience in people management.  

Responsibilities Execute Lilly business requirements for the study/program for vendors to deliver clinical trial data Ensure that data management deliverables are delivered to scope, cost, and time objectives Coordinate end-to-end data management activities – from study set up through trial execution through dataset delivery, including on time delivery of a quality, locked database Ensure flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker) Contribute to key deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets) Participate in submission, inspection and regulatory response activities Central coding activities completed Archiving and decommissioning of study related data management documents and content Ensure that data acquisition, database design, data validation, data review, central coding and observed dataset requirements are reflective of specific protocol objectives Adhere to standards decisions, implementation and compliance for the study/program Track and report out key study build, execution and data deliverable metrics Help create scope scenarios and negotiate outcomes with study teams while considering the cost and value Facilitate the integration of disparate data sources into datasets for decision making Utilize therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables Continually seek and implement means of improving processes to reduce cycle time and decrease work effort Represent Data and Analytics processes in cross-functional initiatives Actively participate in shared learning across Data and Analytics organization   Qualification & Experience Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy  

Responsibilities Conduct PM reviews/ check-ins to evaluate performance (including timelines and quality objectives), business results, impact, and compliance Help the team achieve their goal/target for the financial year Have regular meeting with reporting manager (Associate Director) and discuss about their direct reports Appropriately manage the workload of direct reports; monitor project timelines and quality and communicate priorities to direct reports Provide input on employee development, talent assessment, and keep the Associate Director aware of all the above behaviors on a regular basis Encourage appropriate rewards for deserving individual/group performance and results Ensure all direct reports are compliant with company policies, procedures, and regulations, and most importantly training needs   Qualification & Experience Master’s degree in a Business Management/ Pharma/ Social Sciences/ B.E./ B. Tech Project Management certifications will be a plus  

Responsbilities Coordinates and maintains Labelling lists for Teva products Collaborates with relevant PV departments (Medical Scientific unit, Data Management groups and IT) Provides responses and guidance for other PV and non-PV Teva employees Maintains relevant Labelling list operating procedures Participates in meetings and discussions relevant for Labelling list coordination Collaborates with other departments on relevant system upgrades and process optimization projects involving labelling lists Assures all tasks are performed in line with relevant procedures Other tasks as assigned by the direct manager     Qualification & Experience University degree (Preferably in health care domain) 2-3 years of Health care or Pharmaceutical industry experience and at least 1 year of Pharmacovigilance experience  

Responsibilities Batch record Review & Release: Review of the batch manufacturing and packing records and the supporting records like API COA, Inprocess results, packaging labels, etc., associated with validations, new products and periodic batch record reviews. Change Controls: Life cycle management of change control in Global Trackwise system. Initiate change controls related to EMSO but not limited to the batch manufacturing and packing records, specifications and analytical method of analysis, stability protocols etc., that are received from the CMOs. Deviations and CAPA Management Logging and review of the deviations related to EMSO that are received from various CMO/Suppliers related to: Deviations including manufacturing, Complaints that includes investigations at the manufacturing site. Process Validation: Review of process validation/verification protocol, reports and associated batch documents. NTM/GNTM Impact and Risk Assessment: Coordinate with the CMOs for impact assessment of the GNTMs and provide the impact assessment to the Regional NTM Coordinator.   Qualification & Experience Minimum 6 years of Manufacturing experience in pharmaceutical industry Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment Knowledge on Compliance Standards and Regulation as applicable to the market. Experience of handling Operational Quality, QA exposure and External / Contract manufacturing sites  

Responsibilities Provide International market Regulatory expertise to enable efficient and streamlined tactical delivery of International markets submissions including:Optimisation of submission delivery strategies for assigned products/markets including advising on tactical decision-making Effective communication and collaboration to remove obstacles from submission preparation process and support Marketing Companies in rapid filings and responses to HAQs Use and sharing of best practice working with Int’l markets within the RAM community and role-modelling effective delivery of complex Int’l market submissions Partner with the Regional Regulatory Contacts to feedback applied and relevant knowledge and experience gained from Int’l market submissions to facilitate knowledge-sharing Provide support across iRAM to maintain and continuously improve regulatory consistency and to achieve “right-first-time” submissions in line with agreed plans and metrics Driving creation of International shared packs Ensure development and maintenance of key collaborative relationships and ensure alignment of objectives and visibility of issues/risks and driving issue resolution where necessary Subject matter expert input into Regulatory Intelligence initiatives eg Regulatory Requirements Repository (R3) project Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regionsProvides regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Tactical delivery for International submission dossiers for MAA, CLE and LCM applications in all International markets Coordination, review and authoring contribution to HAQ responses and other associated regulatory aintenance documents Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of complex regulatory maintenance submissions from an International market perspective. Liaises closely with cross-functional members with aligned product responsibilities. Develops, executes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to their line manager and iRAM Lead or as an iRAM Lead to their line manager. Identifies regulatory risks and communicate mitigations to iRAM Lead and cross functional teams or as an iRAM Lead to the cross functional teams. Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management, May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies. Provides coaching, mentoring and knowledge sharing within the Interational regulatory organisation. Actively seeks Continuous Improvement opportunities.   Qualification & Experience Relevant University Degree in Science or related discipline Extensive regulatory experience within the biopharmaceutical industry, with 10+ years working with International markets including new MAAs, CLE’s, licence maintenance and labelling Thorough understanding of drug development and International market Regulatory FrameworksThorough knowledge of the regulatory New MAA roll-out and product maintenance process  

Qualification & Experience Relevant University Degree in Science or related discipline Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry Thorough knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Regulatory affairs experience across a broad range of markets Managed regulatory deliverables at the project level Experience of working with people from locations outside of India, especially Europe and/or USA Excellent English written and verbal communication skills Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions  

Responsibilities Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff Perform statistical analysis for medium complexity studies Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery Review CRF and other study specific specifications and plans ? May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff Provide statistical input and review of the CSR for simple studies Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff