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Senior Manager, Regulatory Affairs
Cambridge, MA, United States Sarepta Therapeutics logo Sarepta Therapeutics
Submission Preparation CMC RNA Gene editing ICH Guidelines Regulatory strategy Documentation Management Gene therapy ICH +19
Senior Full Time
USD 132K+
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Principal Statistical Programmer
United States - Remote Intercept Pharmaceuticals logo Intercept Pharmaceuticals
NDA Submission SAS Macros SAS/ODS SAS/SQL SAS/STAT Base SAS SAS/Graph CDISC standards Ectd +6
Senior Full Time
USD 145K+
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Regulatory and Start Up Specialist
Remote, United States Precision for Medicine logo Precision for Medicine
Translation Coordination IRB Submissions TMF Site start-up Budget negotiation Site visits ICH GCP ICH Guidelines ICH +29
Mid Full Time
USD 80K+
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Regulatory and Start Up Specialist
Remote, United States Precision Medicine Group logo Precision Medicine Group
Translation Coordination IRB Submissions TMF Budget negotiation Site start-up Site visits Contracts Management ICH GCP ICH Guidelines +34
Mid Full Time
USD 80K+
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Partenaire responsable des centres d'étude clinique I / Site Care Partner I
CAN - QC - Remote, Canada Pfizer logo Pfizer
Formation Operational Oversight Outcomes Good Clinical Practice ICH Guidelines Patient Safety Site Management Relationship ICH +26
Mid Full Time
CAD 92K+
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Clinical Trial Manager, Clinical Operations
US- Remote Spyre Therapeutics logo Spyre Therapeutics
Study monitoring Informed consent development EU CTR FDA guidelines Vendor selection Good clinical practices Clinical Trial Management ICH Guidelines ICH +10
Senior Full Time
USD 135K+
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Manager, Regulatory CMC
New York, New York Axsome Therapeutics Inc logo Axsome Therapeutics Inc
Ectd Solid oral dosage forms Regulatory cmc Cder guidance Ep USP FDA Submissions CNS Disorders ICH Guidelines +14
Mid Full Time
USD 95K+
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Scientist, Drug Product
Remote (United States) CG Oncology, Inc. logo CG Oncology, Inc.
CGMP regulations Analytical assays Formulation Development FDA guidelines Characterization ICH Guidelines Clinical Studies Regulatory Submissions Biotechnology +3
Mid Full Time
USD 115K+
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Senior Manager, GPV Aggregate Report & RMP Operations
Remote, United States Otsuka Pharmaceutical Companies logo Otsuka Pharmaceutical Companies
Risk management plans Safety databases Aggregate reporting Electronic document management systems EDMS Data procurement Document management systems Clinical Management ICH Guidelines +44
Senior Mid Full Time
USD 131K+
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Associate Director, Clinical Quality
Remote (United States) Revolution Medicines logo Revolution Medicines
CAPA ICH Guidelines FDA regulations Audit Management Drug Development Clinical operations Regulatory requirements Clinical trials Oncology +11
Senior Mid Full Time
USD 180K+
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Sr. Director/Executive Director, Analytical Development
Remote - United States BridgeBio Inc. logo BridgeBio Inc.
DSC TGA XRPD Karl Fischer Titration CDMO Management ICP USP IR NMR +19
Senior Full Time
USD 230K+
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Director Clinical Development, Solid Tumors
Remote (US), United States BeiGene logo BeiGene
Medical Support Clinical study design Drug development process Biometrics Translational Research Clinical Study Reports Competitor Analysis Budget planning ICH Guidelines +49
Exec Senior Full Time
USD 239K+
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Director, Clinical Management (Nephrology)
Remote, United States Otsuka Pharmaceutical Companies logo Otsuka Pharmaceutical Companies
Financial Estimates Scientific Partnership Clinical Development Plan ICH regulations Regulatory Documents Trial Management Clinical Management Good clinical practices Clinical programs +45
Exec Senior Full Time
USD 183K+
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Senior Director, Biostatistics
United States - Remote Ultragenyx logo Ultragenyx
Statistical Methodologies Clinical programs ICH Guidelines Publications Biostatistics Regulatory Submissions Clinical Development Statistical analysis Reimbursement +6
Senior Full Time
USD 245K+
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Start Up Lead
Remote, United States Precision for Medicine logo Precision for Medicine
Site start-up Critical path planning Budget negotiation ICH Guidelines Documentation Management ICH Precision Medicine Regulatory Submissions Clinical operations +19
Senior Mid Full Time
USD 106K+
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Start Up Lead
Remote, United States Precision Medicine Group logo Precision Medicine Group
Site start-up Critical path planning Budget negotiation Contracts Management Good Clinical Practice ICH Guidelines Documentation Management ICH Precision Medicine +23
Senior Full Time
USD 106K+
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Clinical Trials Lawyer
US - US - Remote Axiom logo Axiom
GCPs Clinical trial agreements Negotiating agreements Legal negotiation Legal Experience ICH Guidelines Contract drafting FDA regulations Legal advice +11
Mid Full Time
USD 115K+
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Senior Manager, Regulatory Affairs Device
Cambridge, MA, United States Sarepta Therapeutics logo Sarepta Therapeutics
Global Regulatory Strategy Gene editing RNA Gene therapy Regulatory strategy ICH Guidelines Documentation Management ICH Regulatory Submissions +8
Senior Full Time
USD 132K+
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Senior Medical Science Liaison (Sr. MSL) – Southwest
San Diego - RayzeBio - CA, United States Bristol Myers Squibb logo Bristol Myers Squibb
Healthcare providers Scientific Dialogue Medical accuracy Radiopharmaceuticals Cell Therapy Medical Insights ICH Guidelines Scientific Exchange Therapeutic Area Expertise +23
Senior Full Time
USD 119K+
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Senior Medical Science Liaison (Sr. MSL) – South Central
San Diego - RayzeBio - CA, United States Bristol Myers Squibb logo Bristol Myers Squibb
Healthcare providers Scientific Dialogue Medical accuracy Radiopharmaceuticals Cell Therapy Medical Insights ICH Guidelines Scientific Exchange Therapeutic Area Expertise +23
Senior Full Time
USD 119K+
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