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Asset Team Program Management (depending on stage of development, the % of time will vary) Creates and regularly maintains the IPP (based on collective inputs of functional project managers and the team representatives). Ensures that plans are aligned with strategic objectives for the program. Schedules Asset Team meetings and works with the Asset General Manager (AGM) to
Posted 6 days ago
Execute department operational, technology, and financial tasks and projects and corporate governance, licensing, and permit matters. Other duties and special projects as assigned. This is a hybrid work arrangement with 3 days in office. Position will be filled at level commensurate with extent of education, experience, and accomplishment. Role Specific Requirements & Res
Posted 25 days ago
60% of time Responsible for end to end execution of the CDx strategy for specific gene therapy programs. Primary point of contact with CDx partner (day to day) to monitor assay development and validation activities, transfer progress, troubleshoot, communicate evolving needs to ensure timely implementation of CDx strategy. Lead the Spark CDx cross functional subteam(s) an
Posted 1 month ago
Provide day to day / routine technical HVAC & Mechanical equipment / system operations and project support for Spark. Cross functionally collaborate with other engineering functions as needed for routine troubleshooting (Digital Systems, Clean Utilities, etc.) Author / and Review deviations pertaining to Mechanical & HVAC systems and support impact assessments for Sparks
Posted 1 month ago
Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of relevant data to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional contributors, an
Posted 1 month ago
Drives strategy and provide insight for potential new clinical programs and projects based on medical need and development requirements; leads the design of clinical programs and study protocols and contributes to their timely execution of all neuroscience clinical programs; Organizes and executes clinical advisory boards to enhance and focus scientific contents of the ne
Posted 1 month ago
Manage and lead the patient safety and pharmacovigilance function including oversight for activities, operations, and continued evolution toward a best in class organization. Leadership of patient safety for our products, including provision of a clearly defined safety strategy, oversight of product emerging safety profiles including signal detection/evaluation from all d
Posted 1 month ago
Advise and provide legal guidance to support business initiatives for stakeholders in the development & product strategy, commercial, and corporate compliance organizations and other business functions in a manner that advances the company's strategy, addresses legal/regulatory risks, and maintains the company's integrity and reputation. Provide transactional support for
Posted 1 month ago
In collaboration with regulatory leads and cross functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Incorporate regulatory strategy and well positioned content into high quality submissions to suppo
Posted 2 months ago
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