Job title: Senior Transparency Associate
Company: The Medicines Company
Job description: Job Description Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilizati
Job Description Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets. You will collaborate with colleagues from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical Development and have the opportunity to support Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career. Your responsibilities include, but are not limited to: . Support the global cross-functional Transparency Submission Team to ensure all Clinical Transparency submission documents are delivered in accordance with timelines, high quality, operational and technical procedures. . May attend Transparency Submission planning meetings with cross-functional team members to support the definition Transparency submission content. . May contribute to pre-submission Health Authority Transparency In Scope Document books applying lessons learned and potential efficiencies used successfully by other Transparency submission teams. . Attend, as required, Transparency Submission Team meetings, to provide support regarding deliverable timelines ensure timelines are in accordance with Novartis processes. . Perform as needed marking and redaction/anonymization of clinical trial documentation using appropriate tools. When required transfer the encrypted raw and analysis data via Intra-links or similar secure tool to Vendor and perform Acceptance Testing on all dataset deliverables received from Vendor, migrating completed anonymized datasets to GPS. . Complete QC on vendor and Novartis deliverables for those projects assigned to. Support publishing, posting and archiving of clinical trial documentation and data sets for disclosure. . Work with Transparency Management to track globally Health Authority requirements specific to the sharing of Clinical Trial data. . Contribute to continuous improvement of submission processing and knowledge transfer within Development via cross-functional ‘Lessons Learned’ sessions. [#video#https://www.youtube-nocookie.com/embed/Mo1vwtVPVA0{#400,300#}#/video#] Minimum requirements . 5+ years experience in the pharmaceutical industry and broad understanding of the drug development process. . Knowledge of clinical trial transparency or clinical trial data areas. . Knowledge of the emerging principles/guidelines governing clinical trial transparency, as well as an understanding of the driving forces and their associated perspectives. . An understanding of the steps, roles and responsibilities in generating clinical trial documentation, data sets, and submissions. . Innovative critical thinking detail-oriented yet pragmatic problem-solving skills. . Understanding of data privacy. Experience in process improvement initiatives. . Good interpersonal and communication skills (verbal and writing) bridging scientific and business needs. Why consider Novartis? 799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Expected salary:
Location: Hyderabad, Telangana
Job date: Thu, 20 Jan 2022 23:45:04 GMT
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