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Merck
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Annapolis, Maryland
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Job Description
Job Summary
This position reports to the Associate Director of
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Merck
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Annapolis, Maryland
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, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across ... local regulatory environment.
Scientific and clinical research knowledge is required
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Merck
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Annapolis, Maryland
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and supervision of the TA Head or CRD.
• Requires strong understanding of local regulatory ... business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader
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Merck
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Annapolis, Maryland
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discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an ... with ability to understand how MIDD can drive portfolio and regulatory decisions
Deep knowledge of
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Merck
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Annapolis, Maryland
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develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring for regulatory documents such as Investigational New Drug application
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Merck
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Annapolis, Maryland
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understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial
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Merck
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Annapolis, Maryland
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internal, FDA, CFIA and USDA regulatory policies. The position will require developing research trial
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