Clinical Trials Jobs in Hyderabad

Summary We are Novartis. Join us and help us reimagine medicine. • Novartis mission: At Novartis, we reimagine medicines to improve and extend people’s lives.• Global Clinical Supply Vision: To become an intelligent, agile organization to deliver more products to more patients more efficiently through empowered and highly capable Global Clinical Supply teams. • Clinical Trial Supply Manager Vision: Be a trusted business partner by designing & delivering clinical supplies to serve our patients with excellenceAbout the RoleHSEMajor accountabilities: • CTSM will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients. • Study managers provides inputs in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design and pro-active planning following a risk-based approach • Represent Global Clinical Supply as a single point of contact (SPOC) at trial level for the integrated Clinical Trial team (iCTT).·Accountability and leadership • Self awareness Open to seek and receive feedback Having Right attitude·Operational & Project excellence • Proactive in study planning and assigned portfolio • Ensures to have robust risk management (identification and mitigation of risks) and various scenarios to support decision-making process • Able to navigate through current processes and procedures , while focusing on continuous improvement • Setting priorities and holding self and others accountable to meet commitments. ·Stakeholder management & Interpersonal skills • Able to engage, influence, align and lead internal and external business partners • Ability to work well with diverse groups of people, handle conflict & challenging situations effectively and build formal and informal relationships·Communication Skills & Business mindset • Able to communicate effectively with different audiences • Ability to consider business necessities and financial indicators when taking decisions and managing budgets. ·Managing Change • Ability to effective rebound from set-backs and adversity when facing difficult situations • Ability to adopt to different situations and to operate effectively during times of uncertainty.Minimum Requirements:Work Experience: • Functional Breadth. • Managing Crises. • People Challenges. • Collaborating across boundaries. • Operations Management and Execution. • Project Management. • 3-4 years relevant experience.Skills: • Advanced Project Management. • Supply Chain Planning. • Supply-Chain Management. • Data & Digital Savviness with high learning agility • Knowledge of relevant regulations (GMP, HSE)Languages : • English.

Job Description : As an experienced Biostatistician, you will lead research design and analytical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts. You will use your knowledge to advise, provide guidance and to oversee the quality control of statistical deliverables. As the functional lead within a study team, you will direct the Biostatistical activities on a study and be accountable for the deliverables. Senior, Principal, and Senior Principle level Biostatisticians at Parexel are client-facing and play an integral part in the study team. Leverage your expertise. Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R). Foster teamwork. Perform intricate statistical analyses and provide input to statistical reports. Share knowledge. Provide input to analysis plans, statistical reports, statistical sections of integrated clinical reports. Impact the process. Be a proactive advisor for all types of analysis from the proposal process through the project life cycle. Take quality seriously. Review analysis data sets and quality control all types of statistical analysis deliverables. Coach and mentor. Train and uplift junior members of the department. Job Qualifications: Experience: A minimum of 5 years industry (or directly relevant) experience ,A thorough understanding of the statistical aspects of either clinical trials and/or observational studies. Experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology. SAS programming or R programming skills (desired) Education: A Masters or Ph.D. level education in biostatistics, statistics, mathematics, or another relevant discipline. Skills: Confidence be self-reliant and a quick learner who enjoys working in a matrixed team. Good leadership skills. Strong oral and written English communication skills. The ability to travel as required, although this is not frequent. A strong work ethic to promote the development of life changing treatments for patients Qualification : A Masters or Ph.D. level education in biostatistics, statistics, mathematics, or another relevant discipline.

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent PAREXEL at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience: Competent in written and oral English. Good communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Job title: Data Scientist Location : IN / Hyderabad About the job An exciting opportunity to join our risk-based monitoring team. Risk-based monitoring (RBM) is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes that have the most potential to impact patient safety and data quality. In this context, the RBM team is responsible for designing, executing, and optimizing the Sanofi RBM approach to align with regulatory requirements and Sanofi's objective to drive quality, efficiency, and speed of clinical trials. The D ata Scientist (DS) is responsible for setting up and refreshing the RBM application for assigned studies, ensuring a seamless data flow, and configuring the system to meet RBM specifications and industry standards. You will work closely with Central Monitors and study Lead DS together to delivery RBM activities. If you are passionate about leveraging data to drive excellence in clinical trials, this is the opportunity for you. Main responsibilities: Data Extraction and Processing:Extract data from various systems and ensure it is preprocessed correctly, supporting the accuracy and reliability of our monitoring processes.. Dashboard Management:You will be in charge of setting up and updating KRI, DQA, QTL, and SPOT dashboards with precision and within the set timelines, adhering to established processes and standards. Script Execution and Updates:Execute SAS or Python scripts, updating parameters as required to meet the specific needs of each study. Collaborative Problem Solving:Provide a clear explanation of results and signals, working closely with Central Monitors and Lead Data Scientists to deliver effective RBM activities. About you Experience: Experience in a Clinical Research environment (CRO or Pharma). Experience in clinical data programming (SAS, Python, R, ) Soft and technical skills: Learns and adapts quickly when facing new problems. Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions. Good at SAS programming skills, it s better be able to develop from scratch. Execute Python script with updating parameters based on studies. Understand clinical trial-related documents with basic clinical knowledge, e.g., Protocol, SDS, CRF. Good interpersonal, communication, and negotiation skills (verbal and written). Able to acquire and apply new technical skills. Education: Bachelor s degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences) Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment. Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team A team that drives the innovation of the monitoring activities that align with future need W e believe that a Data Scientist is not just a job title; it's a role that embodies innovation, curiosity, and the power to transform data into actionable insights. You are the architects of our data-driven future, equipped with the latest technologies and a supportive environment that fosters growth and collaboration. Qualification : Bachelors degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences)

Description Johnson & Johnson Innovative Medicine is recruiting a Data Science Solutions Manager. The primary location for this position is in India (Hyderabad/Bangalore). Innovative Medicine develops treatments that improve the health and lifestyles of people worldwide. Research and Development areas encompass Oncology, Cardiovascular, Immunology, Neuroscience, and Infectious diseases. Our ultimate goal is to help people live longer, healthier lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market from patients to practitioners and from clinics to hospitals. In this role, you will: Partner closely with members of the Innovative Medicine R&D data science organization and other business stakeholders to lead a team to implement data science solutions and business intelligence products. You will be responsible for the delivery of engaging and innovative data products, intuitive solutions, analysis ready datasets, dashboards & insights, to make data more accessible and useful As the Data Science Solutions team, we are responsible for partnering directly with stakeholders to understand business needs and deliver products & education to increase data driven insights and decision making. Responsibilities: Recruit, develop and retain talent Provide direction, mentorship, and coaching to a team of data analysts and visualization specialists, fostering an environment of collaboration, innovation, and professional growth Build and maintain relationships with key stakeholders, ensuring that data products and solutions meet their needs while also advancing organizational goals. Apply the knowledge of pharmaceutical R&D processes to develop innovative solutions and products Ability to lead the team to develop and implement high quality data products, analysis ready data sets and apply human centered design to turn data into insights Collaborate with stakeholders to gather user requirements and understand the business needs. Design wireframes taking a user-centric approach to build intuitive products and iterate quickly to land on an efficient design. Review data products with stakeholders to ensure accuracy and alignment with the desired outcomes Incorporate feedback and suggest improvements to enhance the usability and effectiveness of visualizations. Manage multiple priorities simultaneously and consistently deliver high-quality work within established timelines. Set clear expectations with stakeholders regarding deliverables and project timelines. Stay up-to-date with the latest data management and analysis techniques and industry trends. Proactively identify opportunities to leverage data visualizations for improved decision-making. Qualifications A minimum of a Bachelor s degree is required, preferably with a major data science, bioinformatics, technology with 5 years of experience working in pharmaceutical or relevant industry Requirements: Knowledge and experience with pharmaceutical R&D, clinical development and operations Prior experience in working with clinical trial data: biomarker or clinical trial operations / clinical trial feasibility data Strong proficiency in Tableau and SQL: A portfolio of previously built data visualization is mandatory for interview. Expertise in data visualization principles and best practices. Add ability to query relational databases and work with ad-hoc files. Experience working with large and complex data sets. Experience leading teams Comfortable working with stakeholders to gather user requirements and incorporate feedback. Ability to manage multiple priorities and work effectively in a fast-paced environment. Excellent communication and presentation skills. Attention to detail and ability to ensure accuracy in data visualizations. Qualification : A minimum of a Bachelors degree is required

Job Title: Regional Manager Core Diagnostics Locations: Hyderabad Experience Required: 2 4 Years Industry: In Vitro Diagnostics (IVD) / Healthcare / Medical Devices Employment Type: Full-Time Job Overview We are looking for an ambitious and results-driven Regional Manager to lead sales and business development efforts for our Core Diagnostics division across Hyderabad and Ahmedabad regions. The ideal candidate will have a strong background in IVD sales, relationship management, and regional business expansion, with the ability to drive growth in a competitive diagnostics market. Key Responsibilities Drive sales growth and achieve revenue targets for the Core Diagnostics product line in the assigned region. Build and maintain strong relationships with hospitals, diagnostic labs, and channel partners. Identify new business opportunities and expand market presence in the IVD and healthcare diagnostics sector. Develop and implement territory-specific sales strategies and account plans. Conduct regular product presentations, demos, and training for clients and internal stakeholders. Collaborate with the marketing, technical, and operations teams to ensure smooth execution of regional strategies. Monitor competitor activities and market trends to identify challenges and areas for improvement. Maintain accurate and timely sales data in CRM tools and provide regular reports to senior management. Qualifications & Skills Education: Degree in Medical Laboratory Technology (MLT), Biomedical Engineering, or Pharmacy. Experience: Minimum 2 years of proven experience in IVD sales, preferably in a regional or field role. Strong knowledge of diagnostic instruments and reagents. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and manage a regional territory effectively. Willingness to travel extensively within the assigned geography. Key Competencies Strategic account management Field sales and territory development Product knowledge in clinical diagnostics/IVD Goal orientation and performance-driven mindset Customer relationship and stakeholder engagement Work with a leading name in the IVD and diagnostic industry Opportunity to make a significant impact in a growth-focused environment Competitive compensation and performance-based incentives Collaborative culture with training and development support Apply now and help shape the future of diagnostic healthcare in India. Qualification : Degree in Medical Laboratory Technology (MLT), Biomedical Engineering, or Pharmacy.

We are seeking a dynamic Consultant to lead our team in implementing SAPIO Sciences LIMS and ELN solutions for our clients. This position entails designing solutions and configuring SAPIO Sciences systems to align with client requirements in lab informatics. The ideal candidate will bring a wealth of technical expertise and leadership skills to successfully deliver SAPIO LIMS and ELN projects. Responsibilities Lead SAPIO Sciences LIMS and ELN project implementations Customize and script SAPIO functionalities using Python, JavaScript, and SQL Manage integration of systems using RESTful APIs, Webhook, and web services Utilize port forwarding tools such as ngrok or Cloudflare to facilitate effective system communications Oversee database management for projects, specifically with PostgreSQL or similar technologies Implement cloud deployment strategies for SAPIO solutions using AWS, Azure, or GCP Configure and maintain Gunicorn application servers and ensure smooth operation of Flask/Django frameworks for web applications Set up and manage Nginx reverse proxy servers to optimize system performance Understand and implement lab workflows, sample accessioning, and efficient lab data management practices Ensure compliance with industry standards like GxP, FDA 21 CFR Part 11 in regulated environments Requirements 6 to 12 years of experience in Lab Informatics or related fields Strong technical expertise in SAPIO Sciences LIMS and ELN implementations Background in programming with proficiency in Python, JavaScript, and SQL Extensive experience with databases, focusing on PostgreSQL or equivalent Proficiency in cloud technologies including AWS, Azure, and GCP Excellent capability in managing API integrations and utilizing port forwarding tools Strong knowledge of reverse proxy servers (Nginx) and Python web application servers (Gunicorn) Competency in understanding and managing lab workflows and data management processes Background in working within regulated industries like Pharma, Biotech, etc Nice to have Knowledge of other LIMS/ELN platforms (LabWare, LabVantage) Certification in SAPIO Sciences or related tools Familiarity with laboratory instrument integration We offer Opportunity to work on technical challenges that may impact across geographies Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications Opportunity to share your ideas on international platforms Sponsored Tech Talks & Hackathons Unlimited access to LinkedIn learning solutions Possibility to relocate to any EPAM office for short and long-term projects Focused individual development Benefit package: Health benefits Retirement benefits Paid time off Flexible benefits Forums to explore beyond work passion (CSR, photography, painting, sports, etc.) Qualification : 6 to 12 years of experience in Lab Informatics or related fields

Role:Principal Statistical Modeler - Big Data Location: Hyderabad About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Clinical Moder - Big Data Machine Learning within our Clinical Modeling and Evidence Integration team / Hyderabad, you will develop and implement data cohort creation, data insights and predictive or machine learning models with Big Data (such as large observational study results, electronic health records, Real World Evidence studies) to generate clinical development relevant insights and decision supports. Main responsibilities: Create the cohorts of interest from the big data sources (i.e. electronic health records). Provides data visualization and summaries reports. Develop or implement clinical machine learning models to bridge RWE and clinical inference. Collaborate with cross-functional teams to address scientific questions with integrated RWE and clinical insights. Assist and may work under the direction of clinical modelers. About you Experience: 3 Years of experience in Machine Learning if no PhD Machine learning skills. Experience/Knowledge in Causal inference methods is a plus. Excellent Python and/or R programming skills are required. Experience in tidymodels framework is a plus. Experience using version control systems (eg, Git, GitHub). Soft and technical skills: Good interpersonal and communication skills Good understanding of statistical concepts. Some knowledge about clinical development is a plus. Education: PhD preferred (or MS + 3 Years of experience) in statistics, Machine Learning, Data Science, mathematics or other related disciplines Languages: R, Python, Julia. SAS is a plus Qualification : PhD preferred (or MS + 3 Years of experience) in statistics, Machine Learning, Data Science, mathematics or other related disciplines

Let s do this. Let s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11) Identify, document, and track defects during the testing process. Collaborate with development teams to define validation requirements, resolve defects and validate fixes. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Assist in the development and continuous improvement of validation processes and procedures Stay up to date with industry trends, best practices and evolving regulatory needs We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Experience in defining and executing validation strategies aligned with regulatory requirements Familiarity with risk-based approaches to validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent documentation and report writing skills Good-to-Have Skills: Proficiency in automation tools, data systems, and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com