Drug Formulation Jobs in Bengaluru

Key Responsibilities: Project Management & Execution: Lead and manage application projects related to Electronic Lab Notebooks (ELN) and data analytics. Prepare and track project plans, allocate work, track progress, and ensure end-to-end project delivery. Status & Performance Reporting: Regularly report project status, quality assurance activities, and performance to the customer. Present status reports and ensure the team is aligned with project goals. Documentation & Process Control: Maintain project documentation, including defect prevention checklists and project metrics. Collate status reports and other key documents for project tracking and stakeholder communication. Design & Architecture Reviews: Participate in design and architecture reviews, providing valuable inputs and suggestions. Identify any issues and drive them to resolution to ensure project continuity. Scope & Specification Management: Strategize and draft scoping documents and specifications to clearly communicate the project roadmap and ensure alignment with customer and stakeholder expectations. Cross-Functional Coordination: Collaborate with different teams within the life sciences group to ensure that project requirements are well-captured and reflected in project plans. Plan budgets and resources accordingly. Data Analytics & Dashboard Development: Develop and manage operational, scientific, and trending dashboards, ensuring data accuracy and actionable insights for the business and scientific teams. Validation & Qualification: Lead computer system validation (CSV) executions and the qualification of servers to ensure compliance with necessary standards and regulations. Key Skills: Electronic Lab Notebook (ELN): Expertise in ELN systems and their implementation, including data management, documentation, and integration into lab processes. Project Management: Proficiency in project management tools and methodologies to ensure smooth project execution, including planning, tracking, and resource allocation. Data Analytics & Dashboarding: Strong skills in creating and managing dashboards that provide operational, scientific, and trending data insights for decision-making. Computer System Validation (CSV): Experience in performing system validation activities, ensuring compliance with regulatory standards and guidelines. Documentation & Reporting: Ability to maintain accurate documentation, such as defect prevention checklists, metrics, and status reports. Skilled in presenting information clearly to stakeholders. Cross-Team Collaboration: Strong ability to coordinate with different teams, capture requirements, and plan resources and budgets for each build order, ensuring smooth execution. Quality Assurance: Ensuring that quality assurance activities are in place throughout the project lifecycle, maintaining high standards of work and compliance. Competencies: Business Acumen: Understanding of the business impact of project outcomes and making decisions that align with business goals and customer needs. Presentation & Communication Skills: Strong verbal and written communication skills, with the ability to present complex project details and data insights to stakeholders. Interpersonal Skills: Ability to build strong working relationships with cross-functional teams and stakeholders, ensuring effective collaboration and issue resolution. Team Management: Experience managing project teams, guiding them through day-to-day activities, and providing product perspective and solutions. Negotiation Skills: Ability to negotiate timelines, budgets, and resources with stakeholders and vendors to achieve the best outcomes for the project. Stakeholder Management: Skilled in managing expectations and requirements of internal and external stakeholders, ensuring alignment and satisfaction. Qualification : Bachelors / Masters (Electronic and Instrumentation / Computer Science / IT /Chemistry) with 8 - 10 years of experience.

Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required

Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements

Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience

Scope: This role is responsible for executing chemical reactions to synthesize the required quantities of molecules/compounds as per client specifications, employing efficient synthetic routes and techniques. Key Responsibilities: Reaction Setup & Execution: Understand and follow project requirements, including the synthetic route as specified by the client. Plan and execute reactions using the appropriate reagents and equipment (glassware, stirrers, vacuum pumps, etc.) while maintaining specified conditions (temperature, pressure, etc.). Ensure the parallel execution of multiple reactions, meeting productivity benchmarks for reactions, steps, compounds, and timelines. Monitor reaction progress using analytical techniques, making adjustments as necessary to ensure high quality and yield. Execute appropriate workup and purification techniques to achieve intermediates and final compounds of desired quality. Safety & Risk Mitigation: Discuss and understand the Material Safety Data Sheets (MSDS) with team members to ensure awareness of safety protocols. Identify potential safety risks and mitigate them with the help of a supervisor, ensuring safe lab practices. Follow all safety and quality control systems and maintain proper equipment use as per SOPs and laboratory housekeeping norms. Data Integrity & Reporting: Maintain strict documentation of reactions, observations, and research findings in lab notebooks to ensure data integrity. Ensure compliance with IP confidentiality policies and document results as per client specifications. Prepare final reports to summarize synthesis processes, results, and quality assessments. Team Development & Morale: Foster a learning environment by improving team members knowledge in organic chemistry (synthesis) and analytical techniques through one-on-one discussions, training programs, and educational sessions. Support team skill development and ensure a positive, productive atmosphere in the lab. Functional/Technical Skills: Chemistry Knowledge: Expertise in organic chemistry, particularly in the execution of synthetic reactions and compound synthesis. Safety Protocols: Proficiency in applying safety protocols and ensuring laboratory safety. Data Integrity & IP Confidentiality: Strong understanding of the importance of data integrity and adherence to IP confidentiality guidelines. Resource Management: Ability to perform cost-benefit analysis, optimizing the use of reagents, resources, and equipment for efficient lab operation. Required Qualifications & Experience: Educational Qualification: M.Sc. in Organic or Medicinal Chemistry with 1-5 years of relevant experience. Preferred Qualifications: Candidates with research publications in leading scientific journals are preferred. Qualification : M.Sc. in Organic or Medicinal Chemistry with 1-5 years of relevant experience.

Scope: This role is responsible for executing chemical reactions to synthesize required quantities of molecules/compounds according to client specifications, utilizing efficient synthetic routes and techniques. Key Responsibilities: Reaction Setup & Execution: Understand and execute reactions for synthesizing target molecules/compounds according to project specifications. Plan and execute reactions using proper reagents and equipment (e.g., glassware, stirrers, vacuum pumps) while maintaining specified conditions (temperature, pressure). Ensure parallel execution of multiple reactions. Safety & Risk Mitigation: Discuss and understand the Material Safety Data Sheet (MSDS) with team members. Identify and mitigate potential safety risks with supervisor guidance. Follow safety and quality systems, maintaining laboratory housekeeping and proper equipment usage. Analysis & Reporting: Monitor the reaction progress using analytical techniques. Identify and apply appropriate workup and purification techniques to produce high-quality intermediate/final compounds. Analyze, evaluate, and interpret analytical data from synthesis, providing accurate reports. Document reactions, research findings, and observations in lab notebooks to ensure data integrity. Productivity & Compliance: Meet productivity benchmarks regarding the number of reactions, steps, compounds, quality, and timelines. Maintain strict IP confidentiality and adhere to all policies regarding data integrity. Prepare final reports as required by clients and internal stakeholders. Team Development: Foster a learning environment by improving team knowledge in organic chemistry and analytical techniques. Conduct one-on-one discussions, classroom training, and project-based training to enhance skills. Ensure the team s morale and productivity through continuous skill development. Functional/Technical Skills: Chemistry Expertise: Knowledge of organic chemistry, particularly synthesis and execution techniques. Safety Compliance: Strong understanding of safety protocols in laboratory environments. IP & Confidentiality: Awareness of IP protection, confidentiality, and maintaining data integrity. Resource Optimization: Ability to conduct cost-benefit analysis and ensure the optimum usage of resources. Required Qualifications: Educational Requirements: M.Sc. in Organic/Medicinal Chemistry with 1 5 years of relevant experience. Preferred Qualifications: Candidates with research publications in leading journals are preferred. Equal Employment Opportunity Statement: Aragen provides equal employment opportunities to all individuals regardless of age, color, national origin, citizenship status, mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, genetic information, marital status, veteran status, or any characteristic protected by applicable legislation or local law. Reasonable accommodations will be provided for qualified individuals with disabilities. Qualification : M.Sc. in Organic/Medicinal Chemistry with 15 years of relevant experience.

About ICON: ICON is a world-leading healthcare intelligence and clinical research organization that accelerates the development of drugs and medical devices aimed at improving quality of life and saving lives. We offer outsourced services to pharmaceutical, biotechnology, medical device companies, and government/public health organizations. At the core of ICON s success is our people driven by passion, excellence, and a strong mission to succeed. Role Overview: The Senior ADaM Programmer will be responsible for creating and validating Safety and Efficacy analysis datasets, tables, listings, and figures in adherence with CDISC and client-specific standards. This position requires advanced skills in programming, effective time management, and proactive problem-solving to ensure high-quality deliverables in line with project timelines. Key Responsibilities: Programming & Data Analysis: Create and Validate ADaM Datasets for safety and efficacy domains, ensuring high quality and accuracy. Develop Safety and Efficacy Tables, Listings, and Figures to meet study specifications. Design and finalize study-specific macros and programming specifications/mock-ups. Troubleshoot and resolve programming issues in a timely and efficient manner. Adhere to programming specifications and study-specific requirements, ensuring complete documentation. Project Management & Collaboration: Plan, organize, and allocate tasks to ensure effective resource planning and adherence to project timelines. Proactively track workload and progress in accordance with KPIs and quality standards. Collaborate effectively with the biostatistics team, remote teams, senior programming staff, management, and sponsors to achieve study goals. Quality Control & Documentation: Maintain quality control and ensure the datasets are accurate and meet CDISC standards. Ensure compliance with industry regulations, standard operating procedures, and best practices in clinical programming. Required Qualifications: 6+ years of experience in ADaM programming and R. Strong proficiency in SAS programming, including SAS/Base, PROC SQL, SAS/Stat, SAS Macros, and SAS/Graph (both basic and advanced). Experience in creating ADaM datasets for safety and efficacy domains. Strong problem-solving skills, with attention to detail and ability to work independently and as part of a team. Verbal and written communication skills that ensure effective collaboration across teams and stakeholders. Benefits of Working at ICON: At ICON, we prioritize continuous learning and professional development. Our total reward package includes: Competitive base salary along with variable pay and recognition programs. Comprehensive benefits including health insurance, retirement planning, and more. Employee wellbeing initiatives that support you and your family throughout your career. A collaborative, inclusive work culture where diversity and career growth are encouraged. Diversity & Inclusion at ICON: ICON is an equal opportunity employer, committed to creating a workplace free from discrimination and harassment. We value diversity and encourage applicants from all backgrounds to apply. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. How to Apply: If you're ready to contribute your skills to global healthcare solutions, apply now to join the ICON team and make a meaningful impact on patients lives around the world. This role presents an exciting opportunity for professionals looking to advance their programming career within a global leader in clinical research.

Assistant Manager - F&E (CPDO - Consolidation) Location: Bangalore, Karnataka | Fulfilment & Experience About the Team As part of Meesho's Fulfillment and Experience (F&E) team, you'll play a pivotal role in shaping the logistics framework to support the next billion e-commerce users in India. Our team consists of 100+ smart individuals who are analytical, first-principle problem solvers and get excited about creating 10x impact with innovative solutions. We are reimagining logistics to meet customer expectations of affordability and rapid delivery. Meesho has pioneered many 1st time in India and 1st time in world innovations in fulfillment and experience field. You will be expected to continue and compound on this strong legacy. At Meesho, you'll be driving cutting-edge zero-to-one projects that will redefine e-commerce logistics on a global scale. About the Role As an Assistant Manager - F&E you will be working on a consolidation problem statement. Consolidation - Meesho is a marketplace where currently majority orders are fulfilled by sellers instead of warehouses. Due to this, if a user has ordered 2 products from 2 sellers, they receive 2 separate packets. This leads to higher supply chain costs, higher carbon emissions etc. We are on a mission to figure out innovative ways to consolidate these shipments at various legs in the supply chain to save cost pass on this benefit to the user, and reduce carbon emissions. We are looking for smart problem solvers, strong in analytics and innovative thinkers to solve this first-of-its-kind problem at scale. Your role is to analyse data, understand shipment paths, and come up with various innovative solutions to club orders from the same user together. Identifying opportunities: Problem solving to identify various consolidation opportunities. Work with the supply chain team to understand feasibility and prioritize among them. Design supply chain changes to capture these opportunities. Build & Pilot: Work with product, tech, and on-ground operations teams to build and pilot 0-1 stage solutions. Identify success metrics for pilots and iterate to achieve Product Market Fit (PMF). Scale up: Scale up the successful solutions and move to the next opportunity. What you will need B.Tech or MBA from a premium college 1 3 years of experience, preferably in Strategy & Operations or Management Consulting Ability to handle both strategy formulation and implementation Excellent analytical and problem-solving skills Solid project management skills: ability to lead and collaborate with cross-functional teams, prioritize high-impact activities, and manage complex projects Strong growth track record with demonstrated past results Outstanding written and verbal communication skills, along with strong organizational ability Qualification : B.Tech or MBA from a premium college

Chief Analytics Office (CAO) - Data Scientist Location: Bangalore, Karnataka, India Job Type: Full-Time Experience Level: 2-4 years Company: IBM Chief Analytics Office (CAO) Introduction: At IBM, we believe in the power of AI and data science to transform enterprises. In the Chief Analytics Office (CAO), we work on the front lines of AI-driven enterprise transformations. By joining our team, you will collaborate with innovative leaders and contribute to solving complex problems using the latest AI and machine learning technologies. Here, your skills will not only be valued but nurtured in a dynamic, collaborative environment designed for growth and impact. Role Overview: As a Data Scientist within IBM's Chief Analytics Office, you will play a critical role in driving AI and data science initiatives across the enterprise. You will use your technical expertise to develop and deploy machine learning models and data analytics solutions that align with business objectives. This role is focused on translating data insights into actionable recommendations and leading data science projects from concept to execution. Key Responsibilities: Technical Execution and Leadership: Develop and deploy AI models and data analytics solutions. Assist in the implementation and optimization of AI-driven strategies aligned with business stakeholder requirements. Refine data-driven methodologies for enterprise transformation projects. Data Science and AI: Design, implement, and optimize machine learning solutions and statistical models. Perform end-to-end data analysis, from problem formulation through to deployment. Ensure the scalability of AI solutions by leveraging cloud platforms. Apply IBM s data science standards and reusable assets to ensure quality and consistency. Project Support: Lead and contribute across various stages of AI and data science projects, from data exploration to model development and deployment. Monitor project timelines and assist in resolving any technical challenges. Design and implement measurement frameworks to assess the business impact of AI solutions using KPIs. Collaboration: Work closely with stakeholders to ensure alignment with strategic goals. Collaborate with data engineers, software developers, and other team members to integrate AI solutions into existing systems. Provide technical expertise to cross-functional teams, fostering a collaborative environment. Required Education and Experience: Education: Bachelor s or Master s degree in Computer Science, Data Science, Statistics, or a related field. An advanced degree is strongly preferred. Experience: 2-4 years of experience in data science, AI, or analytics, with a focus on implementing data-driven solutions. Experience with data cleaning, data analysis, A/B testing, and data visualization. Hands-on experience with AI technologies through coursework or projects. Required Technical Skills: Programming and Data Analysis: Proficiency in SQL and Python for data analysis and developing machine learning models. Familiarity with machine learning algorithms such as linear regression, decision trees, random forests, gradient boosting (e.g., XGBoost, LightGBM), neural networks, and deep learning frameworks (e.g., TensorFlow, PyTorch). Cloud Platforms & Data Processing: Experience with cloud-based platforms (e.g., AWS, Azure, IBM Cloud) and data processing frameworks. Specialized Knowledge: Knowledge of large language models (LLMs) and familiarity with IBM s WatsonX product suite. Familiarity with object-oriented programming (OOP) principles. Analytical and Soft Skills: Problem-Solving: Strong analytical skills with the ability to solve complex problems and derive actionable insights from datasets. Communication: Excellent communication skills to explain technical concepts clearly to stakeholders at various levels. Project Management: Ability to handle multiple initiatives simultaneously, prioritize effectively, and meet deadlines in a fast-paced environment. Preferred Experience: Advanced Degree: A Master s degree in a related field is strongly preferred. Impact: Work on innovative projects that directly impact enterprise transformation using the latest AI and data science techniques. Collaboration: Be part of a collaborative environment with a global team of AI experts. Growth: Develop professionally with continuous learning opportunities in the ever-evolving AI field. Work-Life Balance: IBM offers a dynamic work environment with flexibility and career growth opportunities. Apply now and join IBM's Chief Analytics Office as a Data Scientist and be part of the next generation of data-driven innovations. Qualification : A Masters degree in a related field is strongly preferred.

Investigator Payments Analyst Location: Bengaluru Job Overview: The Investigator Payments Analyst is responsible for supporting the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs. This includes pre-award activities and providing essential operational and financial contracting support. The role ensures compliance with sponsor requirements, regulatory guidelines, and project timelines. Essential Functions: Grant Estimates & Proposal Support: Develop simple investigator grant estimates and proposal text to support the proposal development process. Contracting Tools & Systems: Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, ensuring alignment with the Scope of Work and Project Plan. Collaboration & Communication: Coordinate with sponsors, stakeholders, and RSU regions to ensure successful delivery of projects in compliance with sponsor requirements and the RSU Management Plan. Operational & Financial Support: Provide operational and financial contracting support to facilitate business development and efficient initiation and maintenance of clinical trials, ensuring compliance with regulatory requirements. Documentation Support: Assist in creating and reviewing scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance. Contracting Intelligence: Contribute to the collection, interpretation, analysis, and dissemination of contracting intelligence for assigned studies and the company. Efficiency & Reporting: Ensure contracting efficiency and adherence to project timelines and financial goals, and report on performance metrics and out-of-scope activities. Compliance & Quality Standards: Ensure compliance with contract management and quality standards, providing administrative and operational support to investigators and managers as required. System & Database Management: Accurately complete and maintain internal systems (including CTMS), databases, tracking tools, timelines, and project plans. Qualifications: Education: Bachelor's degree required. Experience: At least 1 year of relevant experience, including demonstrable experience as a contract negotiator or equivalent combination of education, training, and experience. Skills & Knowledge: Negotiation & Communication: Strong negotiation and communication skills to facilitate contract discussions and maintain professional relationships with sponsors. Interpersonal Skills: Ability to work effectively in teams and with internal and external stakeholders. Technical Writing: Strong technical writing skills for creating and reviewing proposals and documentation. Clinical Trial Knowledge: Understanding of clinical trial environments and the drug development process. Regulatory Knowledge: Knowledge of GCP/ICH guidelines, applicable regulatory requirements, and SOPs. Organizational Skills: Excellent organizational and planning skills for managing contracting activities. Software Proficiency: Strong knowledge of Microsoft Office and other relevant software tools. Contract Management: Good understanding of clinical trial contract management, including pricing models, proposals, and budgets. Additional Skills: Ability to interpret pricing models, prepare proposals, bid grids, and budgets. Ability to work in a matrix team environment and build effective working relationships with sponsors, co-workers, and managers. Ability to exercise independent judgment when negotiating contracts and making decisions. This role offers an exciting opportunity for individuals who have a strong foundation in contract negotiation and management, along with an understanding of the clinical trial landscape. If you are a detail-oriented, proactive individual with a passion for working in the healthcare and clinical trial industries, we encourage you to apply. Qualification : Bachelor's degree required.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards not to mention various social and recreational activities, all of which are location specific. Job Description: Lead Engineer, Infrastructure and Security The Lead Engineer will take the lead in resolving complex Security Tooling issues and managing escalations to the CCI team and vendors. This position will then plan and work to remediate any misconfigurations to align with Stryker standards that protect while ensuring overall stability. To do this, they will work across multiple teams and functions to help determine issues and use multiple technology platforms to discover issues. Individuals in this position have a broad understanding of key technologies, but a focus on our key toolsets and typically enterprise operating systems. What You Will Do: Provide security support for IT and Security operations and support infrastructure improvements. Provide leadership, vision, and a strong understanding of typical infrastructure platforms and general security principles. Anticipate and recommend changes to processes and documentation that help meet organizational goals and exceed industry best practices and requirements to ensure the security of Stryker assets. Consolidate progress reports and present them in meaningful ways to demonstrate progress to Stryker leadership. Adapt to ever-changing situations by finding more efficient methods to solve problems and train staff on best practices for deploying and managing security software and configurations. Help align security solutions with business strategies, working primarily with line management and IT Business Partners to ensure business security deliverables are aligned with Stryker s global strategy and intervene when appropriate. Improve communications and relations, ensuring the integration of security in technology programs and services across Stryker. Drive adherence to security policies, security programs, and plans; and integrate and coordinate execution of security policies. Implement automation to improve process efficiency and the security tooling compliance state. What You Will Need: Required Qualifications: Minimum Bachelor s Degree in Computer Science or related field. 7 to 10 years of IT Engineering/Operations experience. Strong knowledge of common Datacenter operating systems (MSFT, RHEL). Hands-on experience with Networking, Security Tooling, and Troubleshooting. Strong knowledge of Microsoft Office, specifically Excel for Data Analysis. Preferred Qualifications: Experience with Linux Operating System. Experience with Vendor Management and Project Management. ITIL Foundation and CompTIA Security+ certification is a plus. Health Benefits: Medical and prescription drug insurance Dental insurance Vision insurance Critical illness insurance Accident insurance Hospital indemnity insurance Personalized healthcare support, wellbeing program, and tobacco cessation program Financial Benefits: Health Savings Account (HSA) Flexible Spending Accounts (FSAs) 401(k) plan Employee Stock Purchase Plan (ESPP) Basic life and AD&D insurance Short-term disability insurance About Stryker: Stryker offers innovative products and services in MedSurg, Neurotechnology, and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of their job may be required to obtain various vaccinations as an essential function of their role. Qualification : Minimum Bachelors Degree in Computer Science or related field.

At Databricks, we are obsessed with Data + AI to solve the world's toughest problems, from security threat detection to cancer drug development. We do this by building and running the world's best data and AI infrastructure platform, so our customers can focus on the high-value challenges that are central to their missions. Founded in 2013 by the original creators of Apache Spark , Databricks has grown from a tiny corner office in Berkeley, CA to a global organization with over 6500 employees. Thousands of organizations, from small to Fortune 100, trust Databricks with their mission-critical workloads, making us one of the fastest-growing SaaS companies in the world. The Money team's mission at Databricks is to maximize the value that our customers derive from their investments in data projects. We accomplish this through innovative commercialization strategies, timely & accurate billing, cost optimization tools, intelligent resource usage controls, and cutting-edge engineering. We provide a seamless and consistent set of platforms to enable all Databricks products to reach customers quickly, and sustainably. As the first Engineering Manager for Money at Databricks India, you will be key to building a base for one of Databricks most central engineering orgs. You will own critical components that form the backbone of our business, starting with Databricks resource admission control and usage governance infrastructure. Your role is crucial in helping bring diverse business needs together, including abuse prevention, product commercialization motions, and reliable product availability at scale. You will work closely with infrastructure as well as product teams in bringing critical governance functionality to Databricks customers. The impact you will have: Hire great engineers to build an outstanding team and support their career development by providing clear and timely feedback Ensure high technical standards by instituting processes (architecture reviews, testing) and culture (engineering excellence) Work with engineering and product leadership to build a long-term roadmap Coordinate execution and collaborate across teams to successfully deliver cross-cutting strategic projects What we look for: 10+ years of extensive experience with large-scale distributed systems alongside processes around testing, monitoring, SLAs etc 5+ years of engineering management experience, building, managing and mentoring high-performing software engineering teams Demonstrated success in collaborating with multiple cross-functional stakeholders to align system features and architecture, to deliver impactful platform projects Experience in developing and implementing proactive mechanisms for failure detection and incident prevention Excellent leadership, communication, and project management skills BS (or higher) in Computer Science, or a related field About Databricks Databricks is the data and AI company. More than 10,000 organizations worldwide including Comcast, Cond Nast, Grammarly, and over 50% of the Fortune 500 rely on the Databricks Data Intelligence Platform to unify and democratize data, analytics and AI. Databricks is headquartered in San Francisco, with offices around the globe and was founded by the original creators of Lakehouse, Apache Spark , Delta Lake and MLflow. To learn more, follow Databricks on Twitter,LinkedIn and Facebook . Benefits At Databricks, we strive to provide comprehensive benefits and perks that meet the needs of all of our employees. For specific details on the benefits offered in your region, please visithttps://www.mybenefitsnow.com/databricks. Our Commitment to Diversity and Inclusion At Databricks, we are committed to fostering a diverse and inclusive culture where everyone can excel. We take great care to ensure that our hiring practices are inclusive and meet equal employment opportunity standards. Individuals looking for employment at Databricks are considered without regard to age, color, disability, ethnicity, family or marital status, gender identity or expression, language, national origin, physical and mental ability, political affiliation, race, religion, sexual orientation, socio-economic status, veteran status, and other protected characteristics. Compliance If access to export-controlled technology or source code is required for performance of job duties, it is within Employer's discretion whether to apply for a U.S. government license for such positions, and Employer may decline to proceed with an applicant on this basis alone. Qualification : BS (or higher) in Computer Science, or a related field.

Overview: Collins Aerospace is seeking an experienced Senior Lead Engineer Stress Engineering to join the Aerostructures team. In this critical role, you will leverage your expertise in structural engineering to provide technical solutions for nacelle hardware, ensuring minimal aircraft downtime and compliance with certified type design and airworthiness (FAA/EASA) requirements. You will play a key part in supporting the operational requirements of airline customers and driving solutions in a fast-paced, global environment. Primary Responsibilities: Repair Stress Analysis & Technical Solutions: Perform repair stress analysis and develop analytical methods for medium to complex technical issues, supporting airline operational needs, formal certification reports, and design changes. Engineering Judgments & Repair Solutions: Provide engineering judgments and support margin explorations for nacelle component repairs across various programs, using both metallic and composite structures. Airworthiness Documentation: Prepare airworthiness documents including substantiating analysis and obtain necessary approvals from airworthiness organizations. Customer Communication & Support: Communicate with airline customers to develop rapid technical solutions, collaborating with airframers, engine manufacturers, and suppliers to evaluate and resolve repair data. Collaboration with Cross-functional Teams: Work with the Collins Spares team, Airline/Field Support Managers, and other departments to resolve customer issues effectively. Compliance & Reporting: Ensure compliance with US and country-specific export control requirements. Report to the Aftermarket Technical Services Manager, contributing to the organization s vision of becoming the best aerospace systems company globally. Driving Airline Customer Experience: Work with a diverse global team of engineers, staying at the forefront of improving the airline customer experience. Basic Qualifications: Education: Bachelor s or Master s degree in Mechanical Engineering or Aeronautics. Experience: 6 to 10 years of relevant experience in aerospace structural analysis, including hand analysis and FE tools such as Patran/Nastran. Structural Analysis Expertise: Strong understanding of load paths, load balance, free body diagrams, static and fatigue analyses of metallic and composite aircraft structures. Nacelle Systems Knowledge: Familiarity with nacelle systems for modern aircraft programs (B787, A320Neo, A220, A350). Repair and Inspection Knowledge: Sound knowledge of repair methods for metallic/composite structures and common defects, as well as inspection techniques. Flexible Work Hours: Willingness to work day shifts, weekends, and holidays on rotation as required. Pressure Handling: Ability to work under pressure in a fast-paced environment with short lead times while managing multiple repair tasks. Preferred Qualifications: FEA Expertise: Experience with Patran/Nastran (Sol 101, 106, 111). Customer Support Experience: Previous experience in an aftermarket customer support engineering role. Technical Publications Familiarity: Knowledge of Structural Repair Manual, Component Maintenance Manual, Aircraft Maintenance Manual, Service Bulletins, and Airworthiness Directives. Regulatory Knowledge: Understanding of EASA/FAA requirements and associated repair documentation. About Collins Aerospace: Collins Aerospace is a leader in developing advanced, intelligent solutions for the global aerospace and defense industry. Our Aerostructures business is recognized for its innovative nacelle systems, which improve fuel efficiency, reduce engine noise, and provide critical stopping power during landings. We re continuously evolving to create the next generation of greener, quieter, and more efficient nacelles. Diversity & Inclusion: At Collins Aerospace, we believe diversity drives innovation, and inclusion drives success. We foster a culture that encourages sharing ideas and passion, enabling us to meet the toughest challenges in the aerospace industry and open new paths to possibility. Employee Benefits: Transportation Facility & Meal Coupons Group Term Life Insurance & Health Insurance Group Personal Accident Insurance Employee Scholar Program Work-Life Balance & Car Lease Program National Pension Scheme & Leave Travel Allowance (LTA) Fuel & Maintenance/Driver Wages & Meal Vouchers Ethical & Safety Commitment: Collins Aerospace has a strong commitment to ethics and safety. All positions in India require a background check, which may include a drug screen (only for operations positions). Why Collins Aerospace? At Collins Aerospace, we are redefining aerospace. Join our team of passionate engineers and innovators who are dedicated to creating cutting-edge solutions that push the boundaries of what s possible in air travel. Help us shape the future of aerospace by joining a supportive and inclusive workplace that values growth and creativity. Qualification : Bachelors or Masters degree in Mechanical Engineering or Aeronautics.

Overview: Collins Aerospace is looking for a talented Software Verification Lead Engineer to join the Navigation and Advanced Technology team. In this role, you will be responsible for performing validation and verification for critical avionics systems, focusing on protocols and applications like Maintenance, OMS, and Dataload. You will collaborate with senior developers and architects to design scalable, extensible, and sustainable solutions, while ensuring the highest standards of quality and performance. Primary Responsibilities: Avionics DAL A Product Verification: Verify avionics products in the CNS (Communication, Navigation, and Surveillance) domain, ensuring compliance with industry standards and customer requirements. Tool Development & Test Design: Develop common supporting tools necessary for development and verification activities, as well as create validation tests for avionics systems. Collaboration with Cross-functional Teams: Work closely with architects and senior developers to create scalable solutions, ensuring that new technologies are effectively integrated into the system architecture. CI/CD Pipeline Management: Build CI/CD pipelines and collaborate with the DevOps team to ensure streamlined deployments. Troubleshoot and resolve build issues while supporting deployment processes. Basic Qualifications: Education: BE/B.Tech/ME/M.Tech in Engineering. Experience: 6-8 years of experience in avionics systems and software development. Technical Skills: Proficiency in Python, C/C++, and Matlab/Simulink. Strong understanding of Avionics Systems/Software Architecture, including CNS, FMS, FCS, or Displays. Familiarity with DO-178B/C software standards. Avionics Domain Knowledge: Experience in Communication, Navigation, and Surveillance systems, including protocols for voice and data communications, satellite-based navigation, weather detection, traffic awareness, and collision avoidance. About Collins Aerospace: Collins Aerospace, a Raytheon Technologies company, is a global leader in aerospace and defense solutions. We offer advanced technology and services across a wide array of civil, military, and government missions. Our products are integral to the safety and efficiency of modern aviation, from emergency power systems to reliable cabin controls and quieter engines. Joining our team means being part of a mission-driven company that innovates every day to deliver safer, smarter, and more efficient aerospace systems. Collins Aerospace Diversity & Inclusion Statement: Diversity drives innovation, and inclusion drives success. At Collins Aerospace, we foster a culture that values diversity of thought and experience, which enables us to tackle the toughest challenges in our industry. We are committed to ensuring all employees have the opportunity to share their ideas and passions, paving the way for limitless possibilities. Benefits Package: Insurance: Group Term Life Insurance, Group Health Insurance, Group Personal Accident Insurance. Leave Entitlements: 18 days of vacation and 12 days of contingency leave annually. Employee Programs & Work-life Balance: Employee Scholar Program, work-life balance initiatives, car lease program, National Pension Scheme, Leave Travel Allowance (LTA), and meal vouchers. Additional Benefits: Fuel and maintenance/driver wages, and more! Ethical & Safety Commitment: Collins Aerospace prioritizes strong ethical practices and safety. All positions in India require a background check, which may include a drug screen (for operations positions). Why Collins Aerospace? At Collins Aerospace, we are redefining aerospace. Join our team and be part of a company that plays a critical role in modern flight, providing innovative solutions that enhance safety, efficiency, and the travel experience for millions of passengers worldwide. Qualification : BE/B.Tech/ME/M.Tech with Understanding of Avionics Systems/Software Architecture CNS, FMS, FCS or Displays.

Overview: The Senior Associate Executive - Finance will play a key role in financial planning, analysis, and reporting for a value stream within the organization. This role will involve managing a variety of finance tasks such as budgeting, forecasting, month-end close activities, variance analysis, and internal controls, while also supporting the operations team in achieving financial objectives. The role will require collaboration across teams, strong knowledge of financial systems, and a proactive approach to problem-solving. Primary Responsibilities: AOP & LRP Preparation: Collate and prepare data for AOP (Annual Operating Plan) and LRP (Long Range Plan) reviews, ensuring timely HFM (Hyperion Financial Management) load. Support review meetings and provide detailed financial information to the respective value stream. Monthly Financials & Month-End Close: Complete month-end close activities as per timelines. Prepare monthly journal entries (JVs) and provide details to the parent value stream for day estimates. Review and confirm financial data uploaded in HFM and analyze variances in P&L, Balance Sheet, and Cash Flow. Conduct variance analysis to determine differences between projected and actual results, suggesting corrective actions. Cost Control & Transfer Pricing: Analyze variances related to transfer pricing and collaborate with operations on corrective actions. Ensure pricing updates are completed in SAP. Prepare schedules for balance sheet review and manage ARMS (Accounts Receivable Management System) items. E-CAR & CWIP: Prepare e-CAR (Capital Approval Request) documentation, including financial data (IRR/NPV). Review CWIP (Construction Work in Progress) aging. Tier Meetings & Stakeholder Engagement: Actively participate in tier meetings, supporting value stream leaders in resolving financial issues. Coordinate with stakeholders to discuss operations and the impact on forecasting. Tax & Internal Controls: Understand tax liabilities, reserves booked, and refunds impacting the value stream. Ensure documentation is in place to comply with internal financial controls and statutory requirements (US GAAP, SOX). Reporting & Business Reviews: Prepare presentation decks for monthly PDPR (Product Development & Project Review) and business reviews. Conduct regular meetings with the value stream operation head and leadership team. Qualifications: Education: CA (Chartered Accountant) or ICWA (Institute of Cost and Works Accountants). Experience: 3 to 7 years of experience in plant accounting, reporting, and operations finance. Solid experience in financial planning, month-end close, cost control, and transfer pricing. Experience with SAP and Hyperion Financial Management (HFM). Skills & Knowledge: Proficiency in spreadsheets and MS Office. Strong knowledge of monthly financial and costing close processes. Ability to work with cross-functional teams and resolve finance-related issues. Preferred Qualifications: Knowledge of financial software and ERP systems (SAP, Hyperion). Strong understanding of financial reporting and compliance (US GAAP, SOX). Collins Aerospace Overview: Collins Aerospace, a Raytheon Technologies company, is a leader in innovative solutions for the aerospace and defense industry. We are redefining aerospace by delivering technologies that make modern flight possible. Join our operations team to contribute to our mission of improving productivity, quality, and efficiency across global operations. Collins Aerospace Diversity & Inclusion Statement: Diversity drives innovation; inclusion drives success. We believe that a multitude of approaches and ideas enable us to deliver the best results for our workforce, workplace, and customers. We are committed to fostering a culture where all employees can share their passions and ideas to tackle the toughest challenges in our industry. Benefits Package: Group Term Life Insurance. Group Health Insurance. Group Personal Accident Insurance. 18 days of vacation and 12 days of contingency leave annually. Employee Scholar Program. Work-life balance. Car Lease Program. National Pension Scheme. Leave Travel Allowance (LTA). Fuel & Maintenance / Driver wages. Meal Vouchers. Additional Information: Background check and drug screening required for all new hires in India. Drug screening applies to Operations positions only. Qualification : A Finance and Accounts Professional CA or ICWA.

Job Purpose: The Director Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Global Clinical Operations (GCO) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSK s strategic goals. Key Responsibilities: The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs. As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes comply with regulatory requirements, are aligned with GCO s strategies, consider innovative approaches being developed in the industry, drive efficiency, and are well defined. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively. Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified. Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience. Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale. Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans. Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance. Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCO s strategic priorities and stakeholder needs. Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations. Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies Basic Qualifications Bachelor s degree in Scientific discipline. Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field. Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes with specific expertise in informed consent, clinical trial supplies and distribution of clinical safety documents. Experience leading major projects to completion and driving cross-functional improvements. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities. Forward-thinking and visionary mindset to modernize approach to clinical processes and leverage technology. Demonstrated matrix team leadership to deliver results. Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities. Effective communication skills with ability to communicate and influence. Preferred Qualification Advanced degree in Scientific discipline Qualification : Bachelors degree in Scientific discipline.

Basic Qualification: 16 - 21 Years of professional experience. Experience in Regulatory life Cycle till Phase 4. Location - Bangalore. Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK? If so, this Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore. As Manager, Regulatory Asset Oversight, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan, Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise. Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions. Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle. Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies. Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team. Proactively identifies upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to the Director, Regulatory Asset Oversight, and leadership. Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets. Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function. Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose. Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor s Degree Extensive knowledge of drug development and manufacturing and supply processes. Broad and deep knowledge of worldwide regulatory requirements. Successfully managed multiple projects Preferred Qualifications: If you have the following characteristics, it would be a plus: Degree in Chemistry, pharmacy or closely related science Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Broad knowledge base across regulatory functions. Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings. Line management experience Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making using evidence and applying judgement to balance pace, rigor and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We wan...

Job Title: Statistical Programming Associate Director Career Level - E Introduction to role The Statistical Programming Associate Director is accountable for the quality, timely, and efficient delivery of project programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, you will act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function Leads implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverables and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Identifies opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences stakeholders by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Qualification : Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent