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GlobalLogic Inc., empresa del Grupo Hitachi y líder en ingeniería digital, ha anunciado...

Senior Consultant
Business Solutions
15+ years
India - Bangalore, Noida
Product Owner
Hybrid
Pharma Product leader
Position: Pharma Product Leader
Must have domain: Pharma Business Analyst (R&D, Clinical Trials, Digital Health, Commercial Pharma, SFE, Manufacturing)
Location: Bengaluru (Preferred) or Noida
Job Description
-Facilitate requirement-gathering sessions to document requirements in an Agile way
-Possess Good consulting and pre sales experience.
-Provide direction to the Agile development team and stakeholders with a clear roadmap.
-Create Epics and Stories, ensure development teams understand purpose and objective. Prioritize Stories in a product backlog according to business needs and value. Support the technical design process by defining user journeys and preparing/guiding wireframes.
-Effectively manage the backlog, iteration planning, and elaboration of user stories and acceptance criteria.
-Lead the planning of product release plans and set expectations for the delivery of new functionalities.
-Actively mitigate impediments impacting the team’s successful completion of Release/Sprint Goals.
-Participation in Sprint planning & assessing capacity challenges
-Strong grasp of the clinical trial process and comprehensive knowledge of drug development stages.
-Stay abreast of healthcare regulations, industry standards, and best practices (e.g., HIPAA, HL7, CFR Part 11, CSV) to ensure that technology solutions comply with relevant guidelines.
-In-depth knowledge of regulatory requirements, including FDA, EMA, GMP and ICH guidelines.
-Understand GCP guidelines and their practical application in clinical research.
-Deep understanding of Therapeutic Areas (Oncology, Neurology, Cardiology, etc.), Genomics, Precision Medicine, and allied areas
-Hands-on experience on Real World Evidence & HEOR, Clinical Decision Support systems
-Regulatory understanding USFDA, EMEA, MHRA etc.
-Clinical Trials, eClinical Solutions such as EDC, CTMS, DCT, RBQM etc.
– Understanding of the Pharma Value Chain, Clinical Trials, Digital Therapeutics, Digital Health, SaMD, R&D, Manufacturing, etc.
Culture of caring. At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.
Learning and development. We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.
Interesting & meaningful work. GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.
Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!
High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
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