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changing needs of the regulatory environment Works with RQA colleagues on cross GxP audit plans as required Coaches colleagues - leads training for routine and non-routine site and process audits Advises
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and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate
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colleagues the flexibility and tools they need. The Primary Pharmacology Group offers a collegial and supportive environment for colleagues, with a culture encouraging openness, innovation, and ownership
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. Knowledge of a pharmaceutical clinical research unit environment. Working knowledge of GxP, GCP, CAP and CLIA regulations. Demonstrates teamwork by effective participation in multifunctional teams, motivate
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simultaneous projects in a deadline-oriented environment Direct external vendors and manage budgets, timelines, and quality of deliverables PREFERRED QUALIFICATIONS Experience in assigned therapeutic area NON
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and key external stakeholders through strong interpersonal skills Strong organizational skills to track numerous tasks for multiple simultaneous projects in a deadline-oriented environment Direct
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, serum), detect the presence of anti-drug antibody and neutralizing anti-product antibody activity utilizing various platform in a regulated (GLP, GCP) environment against challenging timelines. Timely
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. Extensive experience using data science models to solve problems in a business environment setting. Experience building, managing, and growing high performing & diverse teams across geographies. Relevant
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supplies, supply chain, GMP/GCP Quality. Ability to work independently seeking guidance as needed. Ability to function in a matrix model and in a team environment. Diverse leadership experiences and
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mathematical calculations and ability to perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel 10% per project needs Relocation support available Work Location