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  

Responsibilities You will be responsible for leading and managing a team of experts in the field of nutrigenomics. Your day-to-day tasks will include overseeing research projects, developing data-driven strategies, and providing guidance on genetic-based personalized nutrition interventions. You will collaborate with cross-functional teams to drive innovation and develop cutting-edge solutions to improve human healthspan.   Qualifications Advanced degree (Ph.D. or equivalent) in Nutrigenomics, Genetics, Molecular Biology, or related field Proven experience in nutrigenomics research and application Strong knowledge of genetics, genomics, and personalized nutrition Experience in leading and managing a team of researchers Ability to analyze and interpret genetic and nutritional data Excellent communication and collaboration skills Publication record in the field of nutrigenomics Experience with laboratory techniques and equipment Ability to stay updated with the latest research and advancements in the field Passionate about improving human health span and increasing lifespan Experience 4+ Year Above  

Responsibilities Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application. Review and approval of change requests through to closure of computerized systems and infrastructure as applicable. May interact with regulators during regulatory inspections and provide relevant documentation as required. Conduct/Manage/Support/ routine computer compliance audits (internal & external) as well as computer compliance initiatives. Identify computer related business, regulatory or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Establish improvement processes, as needed, or set specific measurable targets and goals linked to CSQA/GQA/GSK business needs. Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices. Identify and mitigate computer compliance risks to GSK through effective audits and/or via providing advice and consultancy to GQA and business units regionally and globally. Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments. Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA management.    

Responsibilities Direct the delivery team to take ownership and deliver best possible outcomes through a sound data management, analytics and operations mindset. Work closely with stakeholders to ensure expansion and penetration of Omni use-cases with medical teams. Create a framework for communication, project management and execution across BUs to help drive best practices Take ownership of design, development, maintenance and operations Be a mentor for team members, and drive upskilling plans for LCCI team Serve as trusted career advisor, and work with functional leadership and HR to identify career opportunities for these team members, both systemically (career path development) and with individuals as needed Develop a pipeline of right talent and leadership, and contribute to an inclusive community of analytics expert practitioners Drive standardization, automation agenda across business units to help scale the delivery operations     Qualification & Experience Master’s degree in management/ pharmaceutical or a related field from a premium college Bachelor’s Degree with 12+ years of relevant experience in an allied fucntions such as: BI, data analytics, Omnichannel, integrated marketing, supporting Pharma/Lifesciences Commercial or Medical ops internally or in consulting; at least 6+ in leading teams  

Responsibilities Product or Molecule Safety Physician / Lead Physician Provide global medical leadership and input into all aspects of safety of assigned product(s) including surveillance programs and risk management planning. Ensure proactive safety surveillance: lead risk management activities for assigned products globally lead and guide the surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities; provide support, training and continued improvement as appropriate manage decisions and actions to be taken, including communication to appropriate customers (e.g., Product Teams, Management, Affiliates and Regulators) and liaise with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations; Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities, represent PV position to Global Patient Labeling Committee and/or the Safety Review Committee as appropriate. Build collaborative working relationships with other Global Patient Safety Physicians and development and brand teams medical globally to ensure full cooperation and high quality medical evaluation of safety data for global regulatory purposes. Represent GPS Medical and/or Product on appropriate committees/product development and brand teams. Provide medical support for Global Patient Safety activities and reports within the department, as appropriate. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, early phase development, business units). Provide medical input for review of Adverse Event cases. Lead process and provide medical input for review of Suspected Adverse Reactions Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of laws, regulations and guidance. Understanding and Support of the QPPV role Understanding the roles and responsibilities of the European Union Qualified Person (QPPV) and ensure their involvement in the pharmacovigilance system and processes. Ensure support and information are provided to enable the QPPV to fulfill all the QPPV legal responsibilities. Training, coaching and mentoring Provide training, coaching and mentorship to safety surveillance scientists, and other GPS Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance Provide Global Patient Safety training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, Lilly Medical) as appropriate. Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map. Maintaining compliance with the Lilly Corporate Integrity Agreement. Global Patient Safety Leadership