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Contribute towards the overall Department Regulatory Affairs and Compliance infrastructure at CCA. Promote compliance in CCA’s business operations with all Medicare and Medicaid contractual and regulatory requirements.
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Understands and interprets U.S. and international medical device regulatory requirements, provides guidance on requirements to product development teams. Provides regulatory risk assessments and options to product development teams and management.
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Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA GuidanceExperience with global regulatory submissions (INDs, CTAs, MAAs, DMF’s)Excellent written and verbal communication skillsAttention to detail, organizational skills, and a demonstrated ability to prioritize multiple projectsMotivated, self-starter, able to work independently with minimal supervision.
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Strong clinical research and program management experienced in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function.
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Proven track record negotiating contracts at scale ($100M+) across multiple BUs/vendors/agencies globally including regulatory affairs if possible. As our client is expanding, they require an Associate Director specializing in data strategy and vendor management with experience working on rare diseases datasets.
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Collaborate with cross-functional teams including medical affairs, regulatory affairs, biostatistics, and clinical operations to ensure successful planning and execution of clinical trials.
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