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Associate Director, Regulatory Affairs
Cambridge, MA, United States

Sarepta Therapeutics

Submission Preparation CMC Gene editing RNA Regulatory strategy Gene therapy Regulatory Submissions Regulatory Affairs Controls +11

Senior Mid Full Time

USD 156K+

Associate Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point, United States

Process scale up Sterile drug product Pre-approval inspection readiness Process performance qualification Product characterization Manufacturing investigations Study execution Manufacturing science Statistical Data Analysis +95

Senior Mid Full Time

USD 135K+

Manager/Senior Manager, Promotional Review
New York, New York

Axsome Therapeutics Inc

Promotional Review CNS Disorders Veeva Vault Adobe Acrobat Regulatory Submissions Marketing Operations Drug Development Training and Development Veeva +15

Senior Mid Full Time

USD 110K+

Senior Human Factors Engineer (HFE) / Usability Engineering (UE)
US - California - Thousand Oaks - Field/Remote, United States

Usability Engineering Human Factors Engineering Medical device development Combination products ADAPT Design Controls User Interface Design Labeling Human factors +45

Senior Full Time

USD 133K+

Principal Clinical Pharmacologist - ImmunoOncology
Remote - United States, United States

Quantitative Pharmacology BLA Pharmacodynamics IND Scientific Writing Clinical Study Reports Pharmacokinetics Clinical Pharmacology Strategic development +9

Senior Mid Full Time

USD 148K+

Human Factors Engineer (HFE) / Usability Engineer (UE)
US - California - Thousand Oaks - Field/Remote, United States

Study Moderation Human Factors Engineering Usability Engineering Product validation Combination products ADAPT Design Controls User Interface Design Labeling +45

USD 104K+

Associate Director, Regulatory Affairs Advertising and Promotion
US - SC - offsite, Estados Unidos

Gilead Sciences

Promotional Review Therapies Labeling FDA regulations Commercial Strategy Regulatory Submissions Regulatory Affairs Vision Dental +21

USD 165K+

Associate Director, Clinical Pharmacology & Pharmacometrics
Remote (US), United States

S-Plus Monolix Nonmem Small Molecule CTA Pharmacometrics Oncology Drug Development BLA IND +33

Senior Mid Full Time

USD 139K+

Senior Director-Counsel-Neuroscience Business Unit
US: USA Remote, United States

Eli Lilly and Company

Antitrust law Pharmaceutical marketing laws Data Rights False Claims Act Anti-kickback statute Privacy laws Commercial law Scientific Communications Substance use +26

Senior Full Time

USD 177K+

Sr. Director, European Regulatory Affairs
Remote

European Market Expedited Approval Pathways Pediatric Investigation Plans Advanced Therapy Medicinal Products GxP compliance Cell Therapy Regulatory Submissions Regulatory Affairs Pharmaceuticals +6

Senior Full Time

USD 245K+

Associate Director, Global Biomarker Lead – Oncology Clinical Biomarkers
US - California - Thousand Oaks - Field/Remote, United States

Biomarker research Biomarker analysis Biomarker Strategies Assay Development Pharmacodynamics Biomarkers Translational Research Patient stratification Clinical protocols +31

Senior Mid Full Time

USD 178K+

Senior Regulatory Affairs Specialist (Solventum)
Remote - Minnesota, United States

Solventum Remote-first

Technical Report Review Change Assessments Regulatory processes Vigilance reporting Global Regulatory Strategies Chemical Regulatory filings New Product Development Medical device industry +35

Senior Full Time

USD 137K+

Associate Director, Biostatistics
Remote - United States, United States

Bristol Myers Squibb

Analysis planning Statistical Methodology Cell Therapy Protocol Development Biostatistics Regulatory Submissions Clinical Development Clinical trials Statistics +9

Senior Mid Full Time

USD 189K+

Lead Clinical Biostatistician
US Remote

JMP Oncology testing Probability Theory Statistical Methodology Submissions Statistical Concepts NGS Next-Generation Sequencing Clinical Trial Design +29

Senior Mid Full Time

USD 126K+

Principal Medical Writer, Clinical Affairs
US Remote

Documentation Quality Clinical Performance Study Plans Performance Study Reports Investigator’s Brochures Companion diagnostics Clinical study design Submissions SOP Development Protocol Development +42

Senior Full Time

USD 143K+

Senior Associate - Regulatory Affairs
US - California - Thousand Oaks - Field/Remote, United States

Regulatory Documents Regulatory research BLA Regulatory Documentation IND Meeting Management FDA compliance Regulatory strategy QC +33

USD 89K+

Director, Non-Clinical Drug Safety
Remote, United States

Otsuka Pharmaceutical Companies

Nonclinical studies Genetic toxicology Regulatory Documents Translational Medicine Toxicology Impactful Communication Pharmaceutical Development Pharmacovigilance Scientific communication +22

Exec Senior Full Time

USD 183K+

Analytical & Strategic Improvements Lead
USA - Pennsylvania - West Point, United States

GMP Compliance Lean tools Analytical Testing Method development Method validation Tech Transfer Technology Transfer Analytical Methods Value Stream Mapping +48

Senior Full Time

USD 206K+

Director, Quantitative Pharmacology, Clinical Pharmacology
Remote, United States

Otsuka Pharmaceutical Companies

Pharmacometric analysis Bioanalytical chemistry Pharmacogenomics Phoenix NLME Winnonlin Quantitative Pharmacology Translational Medicine Pharmaceutical products Regulatory Documents +32

Exec Senior Full Time

USD 183K+

United States Regulatory Lead, Senior Manager
US - California - Thousand Oaks - Field/Remote, United States

Labeling Documents Marketing Applications Regulatory policy Regulatory Strategies Regulatory Submission Global Regulatory Strategy Regulatory Intelligence Registration Labeling +37

Senior Full Time

USD 152K+

Scientist, Drug Product
Remote (United States)

CG Oncology, Inc.

CGMP regulations Analytical assays Formulation Development FDA guidelines Characterization ICH Guidelines Clinical Studies Regulatory Submissions Biotechnology +3

USD 115K+

Director, Biostatistics
Remote

Apogee Therapeutics

Adaptive Designs ADaM SDTM Bayesian Methods CDISC Data Monitoring Antibody Engineering Study Design Statistical methods +17

Exec Senior Full Time

USD 225K+

Senior Engineer
USA-MN Mounds View South, United States

Shape memory alloys Biological tissue simulation Superelastic alloys Strain analysis Fatigue analysis Engineering tools Non-linear finite element software Predictive engineering Pulsatile flow simulation +23

Senior Full Time

USD 151K+

Global Safety Medical Director, Immuno-oncology
US - California - Thousand Oaks - Field/Remote, United States

Safety signal assessment Safety analysis Statistical analysis plans Inspection Readiness Clinical Study Reports Medical Director Regulatory filings Evidence Generation Pharmacovigilance +28

Exec Senior Full Time

USD 243K+

Associate Director, CMC Regulatory Affairs
Remote

CAR T Therapy CMC Regulatory Affairs Good Manufacturing Practices Cell and Gene Therapy Regulatory Submissions Regulatory Compliance Interpersonal Project Management Communication

Senior Mid Full Time

USD 175K+

Clinical Research Physician Pain
US: USA Remote, United States

Eli Lilly and Company

Medical Leadership Electronic Data Capture Consultative Support Scientific Leadership Medical Monitoring Medical research Good clinical practices Volunteerism Site Management +30

USD 252K+

Executive Director, Biomarker Development & Translational Research
Remote (US), United States

Biomarker validation Clinical biomarker science Biomarker development Solid Tumor Oncology Drug Development Assay Development Biomarker Strategies Translational Research Scientific communication +34

Exec Senior Full Time

USD 225K+

Principal Biostatistician, FSP, Late Phase
Durham, North Carolina, United States of America

Multiple imputation methods Analysis plans Clinical trial protocols CDASH Statistical analysis plans SDTM ADaM Iqvia CDISC +23

Senior Full Time

USD 131K+

Sr. Director/Executive Director, Analytical Development
Remote - United States

DSC TGA XRPD Karl Fischer Titration CDMO Management ICP USP IR NMR +19

Senior Full Time

USD 230K+

Senior Manager, CTA Regulatory Strategy - Remote
Remote, United States

Otsuka Pharmaceutical Companies

Global regulatory plans Clinical Trial Applications Document management systems Documentum Regulatory support Global Regulatory Strategy Regulatory Intelligence Clinical Management Regulatory strategy +34

Senior Full Time

USD 146K+

UNIV - Research Program Coordinator I - Journey - Pediatrics: PRG
Charleston, United States

Medical University of South Carolina

Research documentation Biological specimen management Study coordination ALCOA++ Medical chart review Biological specimens Patient Recruitment Regulatory Submissions EPIC +7

USD 38K+

Clinical Research Coordinator B (Department of Radiology)
HUP, United States

University of Pennsylvania

Research Protocols Patient Coordination Regulatory Submissions Clinical trials Clinical Research Data Entry Behavioral health Regulatory Compliance Data Management +5

USD 52K+

Principal Biostatistician
USA IRV-17011 Redhill/DBC1-5, United States

Edwards Lifesciences

Trial simulations Clinical Affairs Statistical Methodologies Data Quality Assurance Statistical Programming Regulatory Guidelines ICH Statistical methods ISO +31

Senior Mid Full Time

USD 129K+

Biostatistician III
New York City, NY

Ecg prediction models Prognostic algorithms Cancer genetics Statistical strategy Time-to-event analysis Predictive algorithms Statistical Methodologies Survival analysis Real-world data +29

Senior Mid Full Time

USD 115K+

Manager/Senior Manager, Regulatory Affairs - CDx
Chicago, IL

Quality Systems Standards Clinical Decision Support Software CAP/CLIA Clinical decision support Software validation Good Clinical Practice ISO 13485 Clinical Care Bioinformatics +26

Senior Full Time

USD 110K+

Biostatistician III
Chicago, IL, NYC, NY, Redwood City, CA, Boston, MA

Cancer genetics Statistical strategy Prognostic algorithms Time-to-event analysis Predictive algorithms Statistical Methodologies Survival analysis Real-world data Experimental Design +28

Senior Mid Full Time

USD 100K+

Sr. Medical Director, Drug Safety & Pharmacovigilance
Remote - United States

Deviations Drug Safety Medical Review Safety management Medical Writing Pharmacovigilance Regulatory Submissions Regulatory Affairs Clinical Development +11

Senior Full Time

USD 300K+

Executive Director, Biologics Drug Substance Commercialization
USA - Pennsylvania - West Point, United States

Drug Substance Expression QBD Biologic BLA Process Characterization Development and commercialization Biological Technology Transfer +50

Exec Senior Full Time

USD 227K+

Senior/Director of Biostatistics, Rare Disease, FSP
Durham, North Carolina, United States of America

Clinical development plans Multiple imputation methodologies NDA submissions Statistical problem-solving Clinical trial methodology Sample size calculations ADaM Statistical Methodology Statistical analysis plans +39

Senior Full Time

USD 161K+

Associate Director, Safety Scientist
Cambridge, MA, United States

Sarepta Therapeutics

Safety reporting Signal detection Gene editing RNA Medical Review Gene therapy Pharmacovigilance ICH Regulatory Submissions +12

USD 156K+

Director, Clinical Quality and Compliance
USA - Remote, United States

CE IVDR Clinical Compliance Clinical Affairs GLP Smartsheets CAPA Clinical Quality Danaher Business System +26

Exec Senior Full Time

USD 140K+

Senior Director Global Regulatory Lead (Early Phase) - Oncology
US: USA Remote, United States

Eli Lilly and Company

Global Regulatory Affairs Corporate Communications Regulatory strategy Scientific Expertise Pharmaceutical Development Volunteerism Philanthropy Value proposition Regulatory Submissions +24

Senior Full Time

USD 162K+

Senior Manager - Product Stability and Expiry
Remote

Apogee Therapeutics

Monoclonal Antibody Stability testing Antibody Engineering Analytical Chemistry Biochemistry GMP Biologics Immunology Regulatory Submissions +14

Senior Full Time

USD 150K+

Senior Director, Biostatistics
United States - Remote

Statistical Methodologies Clinical programs ICH Guidelines Publications Biostatistics Regulatory Submissions Clinical Development Statistical analysis Reimbursement +6

Senior Full Time

USD 245K+

Senior Director, Clinical Pharmacology
New York, New York

Axsome Therapeutics Inc

Winnonlin Modeling and simulation software Nonmem Pharmacodynamics CNS Disorders Pharmacokinetics Clinical Trial Design Good Clinical Practice Protocols +11

Senior Full Time

USD 245K+

Director, Clinical Pharmacology Lead
USA - Pennsylvania - Plymouth Meeting, Amerika Birleşik Devletleri

Biomarker Strategy Modeling and Simulation Pharmacometrics Pharmacodynamics Translational Medicine Pharmacokinetics Clinical Pharmacology Study Design ICH +14

Senior Full Time

USD 150K+

Regulatory Manager
Remote, United States

Precision for Medicine

Clinical Study Interpretation Scientific Advice Drug development process ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +21

USD 106K+

Regulatory Manager
Remote, United States

Precision Medicine Group

Clinical Study Interpretation Scientific Advice Timeline development ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +25

USD 106K+

Start Up Lead
Remote, United States

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+

Start Up Lead
Remote, United States

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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