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This role involves leading the regulatory strategy for a cardiology medical device company, focusing on FDA, CE, and UKCA submissions, and ensuring compliance with international regulations. You will work closely with the senior team and regulatory bodies, driving the company's expansion into new markets.
Oversees the end-to-end process for internal and external clinical data sharing requests, ensuring compliance with privacy standards and procedures. Manages vendors performing anonymisation and synthetisation, serves as the primary contact for YODA Project requests, and supports external research teams using clinical study data. Operates independently as a subject matter expert within the Clinical Data Standards and Transparency team.
Oversees the end-to-end process for internal and external clinical data sharing requests, ensuring compliance with privacy standards and procedures. Manages vendors performing anonymisation and synthetisation, and serves as the primary contact for YODA Project requests, supporting external research teams using clinical study data.
Oversees the end-to-end process for internal and external clinical data sharing requests, ensuring compliance with privacy standards and procedures. Manages vendors performing anonymisation and synthetisation, serves as the primary contact for YODA Project requests, and supports external research teams using clinical study data. Operates independently as a subject matter expert within the Clinical Data Standards and Transparency team.
Senior analyst role accountable for global PLAN business process validation and release adoption across Transcend EMEA-OTC releases, working with the project team and local business partners on release cut-over. Drives process scoping, testing strategy (BST, UAT, regression), solution design workshops, operational readiness, and hypercare for a multi-year SAP S/4HANA supply chain transformation.
