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Associate Medical Director, Hematology

Company: Gateway Recruiting - Executive Recruiters
Location: Santa Clara
Posted on: February 19, 2021

Job Description:

Job Summary:The Associate Medical Director provides daily business operations support for Medical Affair issues related to product development, on market quality issues, compliance issues, commercial/marketing activities and customer interactions. The incumbent assists the Medical Director in being medical representative of Hematology to external regulatory agencies and professional societies.Responsibilities:* Supports R&D activities by providing medical input to user needs, product requirements, Verification and Validation protocols and data reviews.* Provides medical input and contributes to Regulatory and Quality documentation as needed as part of regulatory submissions, compliance, and remediation activities.* Develops initial Medical Opinions, Medical Platform Documents and Health Hazard Assessments for review by Medical Director.* Provides medical input to and acts as subject matter expert for on-market quality issues impacting patient results.* Assists investigation teams by providing medical input as needed.* Serves as medical representative in Risk Management activities.* Assist the Medical Director with providing clinical and scientific support in responding to inquiries from healthcare professionals and organizations.* Provides medical input to developing and contributes to the execution of the Company's Hematology's scientific and publication strategy.* Provides medical input for promotional and commercial activities as requested.* Continuously maintain "state of the art" level of knowledge.* Provides Medical Affairs input at a site level.* Work is reviewed by Medical Director (or above) prior to approval.* Self-directed with strong initiative. Works independently; initiates learning and decision-making without much initial information.* Ability to establish and build close working relationships across a highly matrixed organization.* Provide timely responses to prevent delay is project timelines.Education and Experience:Required: * MD Degree* 3 years clinical experience Preferred: * Minimum 3 years of Medical Device industry experience in Medical, Scientific or Clinical Affairs or R&D; IVD industry experience is a plus.* Board Certification is a plus.* Clinical or Anatomic Pathology experience is desired.* Clinical or Laboratory Hematology experience is a plus.* Strong written and oral communication skills. Ability to influence and creatively and effectively challenge the thinking of others.* Experience with data analytics and biostatistics.* Working knowledge of FDA/EU regulations and the clinical laboratory regulatory environment are a plus.Powered by JazzHRpsKebctomT

Keywords: Gateway Recruiting - Executive Recruiters, Santa Clara , Associate Medical Director, Hematology, Executive , Santa Clara, California

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