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Digital GRA Technical Expert - Registration & Submission

Company: Sanofi
Location: Bridgewater
Posted on: June 25, 2022

Job Description:

POSITION TITLEDIGITAL R&D Global Regulatory Affairs - Digital Technical Expert - GRAJOB OVERVIEWAs a Digital Technical Expert for Global Regulatory Affairs (GRA), you will provide technical expertise on the development and implementation of technology solutions to enable Global Regulatory Affairs in the preparation, tracking, and submission of information to secure and maintain Sanofi's license to develop, manufacture and market pharmaceutical products worldwide. The GRA application landscape includes a mix of commercial off-the-shelf, customized commercial, and in-house developed applications. You will provide technical expertise over the entire project and system lifecycles, providing technical expertise, ranging from consulting, up to and including hands-on development.RESPONSIBILITIESWork and collaborate with GRA and IT stakeholders to understand and to provide relevant IT solutions aligned with GRA business stakes and context, and to solicit cooperation and resolve problems.Elaborate, develop and implement applications & processes to support project & maintenance activities of the service, provide GRA solution users with both technical & process expertise for computer problems.Develop & Design the overall application & service landscape, and be accountable for the efficiency of the designed applications and processes at optimized costs.Act as a promoter for technology & process evolution in his/her area of expertise.REQUIREMENTS & QUALIFICATIONS5 - 10 years relevant experience, in a related field (Pharmaceutical IT, Life Science R&D IT).Bachelor's degree or higher in computing, computer science or related technical discipline (Electronic, Physics, Mathematics).Strong technical skills in IT development & Methodology in any of the following:Software programming (Java, Python, .NET and/or SQL preferred, Lambda).Cloud Technologies (Azure, AWS, and/or Google preferred).Reporting, Analytics, and Visualization Technologies (QlikSense, Power BI, Tableau,).Veeva Vault.Agile (Scrum Master) & Waterfall (methodology and documentation).Experience with large-scale complex system implementation and in supporting global solutions / IT services.Strong knowledge in regulatory affairs and highly regulated environments preferred (Regulatory Tracking, Submission, Regulatory Document, Dossier management, Regulatory Intelligence, and Regulatory Requirements).Technology evolution monitoring, curious, eager to understand new technologies.Autonomous & Transversal leadership, able to federate internal & external teams.Team player, capacity to collaborate transversally and internationally.Business-driven - Able to create a trustful partnership.Transparent, strong verbal and written communication skills.Ability to influence & negotiate.Ability to challenge non-added-value activities.Proactivity & source of proposals.Agile in a moving environment.Excellent ability to prioritize, estimate, plan & deliver.Great ability to analyze & synthesize.Be able to identify and manage risks.Rigor and methodological approach.International English.TERMS OF EMPLOYMENTStart Date: Early 2022.Working Hours: Typical US working hours, with emphasis on morning availability to collaborate with European colleagues. Flexibility in hours to collaborate with Asia-Pacific time zones as needed.Minimal travel expected, both domestic and international, to support projects, maintain applications, and personal development.WHAT MAKES THIS POSITION UNIQUE?Global Regulatory Affairs (GRA) plays a crucial role at Sanofi and is involved in all stages of drug development, approval, and post-marketing activities, worldwide, and is highly dependent on technology to fulfill their charter. In this role, you will be a key contributor to GRA's and Sanofi's success, in a challenging and ever-changing environment.BENEFITS OF WORKING IN THIS ROLEDevelop and refine skills in technology used by GRA, included but not limited to cloud computing, analytic, document management, software development, implementation, and support.Develop and refine business knowledge related to GRA, including but not limited to regulatory requirements, intelligence, submission tracking, planning, and analysis.Advance according to technology or service-related tracks.LOCATION INFORMATIONBridgewater, NJ preferred. Boston, MA also considered.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.GD-SALI-SAPDNAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.PDN-957dc4aa-7f8c-4f79-bfba-8d66c2901968

Keywords: Sanofi, Trenton , Digital GRA Technical Expert - Registration & Submission, IT / Software / Systems , Bridgewater, New Jersey

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