Medical Monitor IV

Medical Monitor (Contract) 6 month contract Remote, EST hours Responsibilities Provide clinical development support across late-stage programs, including scientific review, interpretation of clinical data, and preparation of regulatory deliverables.Collaborate with Clinical Development, Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners to support clinical trial execution and reporting.Review and interpret clinical trial data, including tables, listings, and figures (TLFs).Support medical data review, data cleaning, and issue resolution with internal teams and CROs.Analyze safety and efficacy data, including post hoc and exploratory analyses.Author, review, and finalize key clinical and regulatory documents, including:Clinical Study Reports (CSRs)Integrated Summary of Safety (ISS)Integrated Summary of Efficacy (ISE)Investigator's Brochure (IB) updatesDevelopment Safety Update Reports (DSURs)Clinical sections of regulatory submissions and briefing documentsStudy narratives and narrative reviewsContribute to the development and review of:Clinical protocols and protocol amendmentsInformed Consent Forms (ICFs)Statistical Analysis Plans (SAPs) in collaboration with BiometricsClinical trial plans and supporting study documentationProvide clinical guidance on protocol interpretation and study conduct during trial execution.Serve as the clinical point of contact for CROs and external vendors.Participate in CRO meetings to address protocol questions, data review issues, and trial conduct topics.Review CRO deliverables related to clinical data, reports, and regulatory submissions.Participate in Safety Review Team meetings and collaborate with Pharmacovigilance on safety assessments.Review emerging safety signals and contribute to benefit-risk evaluations and safety documentation.Support cross-program documentation, regulatory responses, and inspection readiness activities as needed. Qualifications MD or DO required.Minimum of 5 years of drug development experience within the pharmaceutical or biotechnology industry.Experience serving as a Medical Monitor or supporting clinical development programs.Experience reviewing clinical trial safety and efficacy data.Experience authoring and reviewing clinical and regulatory documents, including CSRs, ISS/ISE, IBs, DSURs, and clinical protocols.Experience collaborating with cross-functional teams, including Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners.Experience supporting late-stage clinical development programs preferred.Nephrology and/or Immunology therapeutic area experience preferred.Strong clinical data interpretation, scientific writing, and communication skills.Ability to manage multiple priorities in a collaborative, cross-functional environment.