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Senior Counsel Duties: Provide legal counsel and support to Company senior management and staff under the direction of the CLO, as part of fast-paced in-house legal team. Daily Contract Development, Negotiation, ..
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... to external bodies (e.g. during regulatory inspections and in responses to ... Supports the review of key compliance and quality metrics associated with ... of regional cases processed With..
... Biometrics, Non-clinical, Quality Assurance, and Regulatory Affairs), demonstrating a strong ability ... study timelines, while enforcing GxP compliance. Collaborate with Bioanalytics and CRO's ... integrity. Assist in budget and..
... ensures adherence to reimbursement and regulatory guidelines and leads the overall ... partnership with Legal, Ethics & Compliance, Health Economics/Outcomes Research, Medical & ... Medical & Development, Alliance Management,..
... established goals and objectives in compliance with applicable GCP/ICH guidelines and ... applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication ... trials and/or Manage Clinical Science..
... affiliates, and Commercial), to ensure compliance with regulations in Good Clinical ... tier and risk rating, in compliance with the pre-defined QA Vendor ... to the Astellas organization and..
... This role will handle all regulatory submissions related to Xtandi capsules ... strategic planning and execution of regulatory activities for development, registration and ... the generation and completion of..
... activities of General Counsel performing contract review, insurance management, and other ... matters such as commercial contracts, compliance, business transactions, governance, litigation management, ... litigation management, human resources, and..
... mission. Contributes to establishment of contract parameters, collects key metric information, ... Interface Management lead, responsible for regulatory compliance and inspection readiness for the ... expert in product modalities,..
... but activities may expand, or contract based on business needs. This ... in accordance with all statutory, regulatory and group reporting requirements. This ... awareness, financial reporting, and enabling..