Job Description

Description:Join GlobalLogic, to be a valid part of the team working on a huge software project for the world-class company providing M2M / IoT 4G/5G modules e.g. to the automotive, healthcare and logistics industries. Through our engagement, we contribute to our customer in developing the end-user modules firmware, implementing new features, maintaining compatibility with the newest telecommunication and industry standards, as well as performing analysis and estimations of the customer requirements.Requirements:Must Have: Healthcare and Life science domain knowledge,
Good to have: Life Science Business Analyst Certificate (LSBA), Clinical Trials Data Management CertificateJob Responsibilities:Responsibilities:
-Facilitate the requirement gathering sessions to gather requirements and document them in an Agile way
-Provides direction to the Agile development team and stakeholders with a clear roadmap.
-Create Epics and Stories, assure development teams understand purpose and objective; prioritizes Stories in a product backlog according to business needs and value; support technical design process by defining user journeys, preparing/guiding wireframes.
-Effectively manage backlog, iteration planning, and elaboration of the user stories and acceptance criteria.
-Lead the planning product release plans and set expectations for delivery of new functionalities.
-Provide an active role in mitigating impediments impacting successful team completion of Release/Sprint Goals.
-Participation in Sprint planning & assessing capacity challenges
-Strong grasp of the clinical trial process and comprehensive knowledge of the stages of drug development.
-Stay abreast with 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 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 Pharma Value Chain, Clinical Trials, Digital Therapeutics, Digital Health, SaMD, R&D, Manufacturing, etc.What We OfferExciting Projects: We focus on industries like High-Tech, communication, media, healthcare, retail and telecom. Our customer list is full of fantastic global brands and leaders who love what we build for them.Collaborative Environment: You Can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment - or even abroad in one of our global centers or client facilities!Work-Life Balance: GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules, opportunities to work from home, and paid time off and holidays.Professional Development: Our dedicated Learning & Development team regularly organizes Communication skills training(GL Vantage, Toast Master),Stress Management program, professional certifications, and technical and soft skill trainings.Excellent Benefits: We provide our employees with competitive salaries, family medical insurance, Group Term Life Insurance, Group Personal Accident Insurance , NPS(National Pension Scheme ), Periodic health awareness program, extended maternity leave, annual performance bonuses, and referral bonuses.Fun Perks: We want you to love where you work, which is why we host sports events, cultural activities, offer food on subsidies rates, Corporate parties. Our vibrant offices also include dedicated GL Zones, rooftop decks and GL Club where you can drink coffee or tea with your colleagues over a game of table and offer discounts for popular stores and restaurants!About GlobalLogic GlobalLogic is a leader in digital engineering. We help brands across the globe design and build innovative products, platforms, and digital experiences for the modern world. By integrating experience design, complex engineering, and data expertise-we help our clients imagine what's possible, and accelerate their transition into tomorrow's digital businesses. Headquartered in Silicon Valley, GlobalLogic operates design studios and engineering centers around the world, extending our deep expertise to customers in the automotive, communications, financial services, healthcare and life sciences, manufacturing, media and entertainment, semiconductor, and technology industries. GlobalLogic is a Hitachi Group Company operating under Hitachi, Ltd. (TSE: 6501) which contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business.

GlobalLogic