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Regulatory Submissions Remote Jobs

40 fresh jobs found

Senior Epidemiologist
San Francisco, Remote

PicnicHealth Remote-first

Patient reported outcomes Observational Research Epidemiology Study Design Health Economics Electronic Health Records Biostatistics Regulatory Submissions Clinical operations +13

Senior Full Time

USD 160K+

Associate Director/Director of Biostatistics
London, England, United Kingdom · New York, New York, United States · Oxford, England, United Kingdom · Remote Opportunity - Canada · Remote Opportunity - United Kingdom · Remote Opportunity - United States · Salt Lake City, Utah, United States · Toronto, Ontario, Canada

SDTM CDISC Data Standards Rare diseases Statistical methods ICH Biostatistics Regulatory Submissions Drug Development +10

Senior Mid Full Time

USD 168K+

Senior Statistical Programmer Analyst
Your Remote US Home Office

SAS ODS Macro Programming Clinical Data Standards SAS/Graph 21 CFR Part 11 SAS/STAT CFR SAS SQL Compliance principles +16

Senior Full Time

USD 140K+

Senior Clinical Evaluation Medical Writer - CRDN
USA-MN, United States

Clinical evaluation Medical Device Regulations Clinical evidence Data Extraction Medical Writing Healthcare Access MS Project Medical Technology Regulatory Submissions +31

Senior Full Time

USD 154K+

Dir, Analytical R&D Biologics Potency
USA - New Jersey - Rahway, United States

Enzyme-Linked Immunosorbent Assay Scientific strategy Quality attributes Cell line engineering Quality by design Cell-based assays Analytical Research Health authorities Cell Biology +69

Exec Senior Full Time

USD 169K+

Manager, Clinical Operations
US - Work From Home, United States

Assay Technologies Clinical Data Review Transfusion Medicine Clinical Chemistry Molecular Testing Clinical Laboratory Immunoassay Regulatory Submissions Cross-functional Team Leadership +7

Senior Mid Full Time

USD 120K+

Manager, Statistical Programming, SDTM Implementation
Remote - United States, United States

Bristol Myers Squibb

Programming Best Practices SDTM Implementation CDISC Standards SDTM ADaM CDISC Statistical Programming Cell Therapy Regulatory Submissions +12

USD 101K+

Research Compliance Specialist
Remote Location, United States

The Ohio State University

IRB applications Research databases Conflict of Interest IRB Research Compliance Regulatory Submissions Microsoft Office Interpersonal Project Management +1

Entry Mid Part Time

USD 48K+

Sr. Manager, Consumer Marketing, Rare Disease (Remote)
US - Illinois - Chicago - Field/Remote, United States

KPI planning Website Development KPI Consumer Insights Digital strategy Patient Engagement Social Media Strategy Brand Strategy Programmatic Advertising +33

Senior Mid Full Time

USD 152K+

Clinical Research Associate II
Remote, United States

Precision Medicine Group

Study Start-Up Lupus ICH GCP Precision Medicine ICH Regulatory Submissions SOPS Clinical Studies Pharmaceutical Industry +19

USD 96K+

Clinical Research Medical Director - Obesity/Cardiovascular, US - Remote
US - California - Thousand Oaks - Field/Remote, United States

EMEA Regulations International regulatory requirements Pharmaceutical Product Development Metabolic Patient reported outcomes Basic Science Research Metabolic diseases Clinical trial data Good clinical practices +51

Exec Mid Full Time

USD 256K+

Scientific Lead, CMC Bioconjugation
US: USA Remote, United States

Eli Lilly and Company

Bioconjugation Conjugation chemistries Process control strategies Antibody-drug conjugates Quality by design Process Validation Volunteerism ICH Regulatory Submissions +11

Senior Mid Full Time

USD 121K+

Clinical Research Associate, Endotronix
USA-Illinois-Remote, United States

Edwards Lifesciences

Cardiovascular anatomy Clinical Project Management Clinical Systems Electronic Data Capture Clinical protocols ETMF CTMS Clinical Data Management Clinical Data +25

USD 85K+

Executive Director, Regulatory Affairs - Cell Medicine
Remote - United States, United States

NDA CTA BLA Gene therapy IND CMC Cell Therapy Biologics Regulatory Submissions +12

Exec Senior Full Time

USD 251K+

Director, Clinical Biostatistics
San Carlos, California

Clinical Study Reports Biostatistics Regulatory Submissions Data Reporting SAS Clinical trials Statistical analysis R Quality Assurance +4

Exec Senior Full Time

USD 244K+

Senior Scientist, Engineering
USA - Pennsylvania - West Point, United States

Bioprocess Bioconjugation Large molecule manufacturing Drug substance commercialization Risk-based methodology Mechanistic understanding Therapeutic proteins Scale-down Performance qualification +58

Senior Mid Full Time

USD 111K+

Director, Analytical R&D
USA - New Jersey - Rahway, United States

Resource modeling Assay qualification Fusion proteins Quality attributes Antibody-drug conjugates Antibodies GMP Compliance QbD IEX +75

Exec Senior Full Time

USD 164K+

Principal Biostatistician FSP, Renal Disease
Durham, North Carolina, United States of America

ICH E9 CDASH Exploratory analyses Clinical trial protocols Statistical analysis plans ICH GCP SDTM ADaM CDISC +22

Senior Full Time

USD 131K+

Scientist- Research and Development
REMOTE- Illinois, United States

Medline Industries, LP

CE technical files Chemical characterization Toxicological assessments ANDA Medical device standards ISO 10993 Biocompatibility Device evaluation OOS investigations +19

Senior Full Time

USD 115K+

Clinical Research Senior Medical Scientist, Endocrinology - US, Remote
US - California - Thousand Oaks - Field/Remote, United States

Safety Assessments Scientific method Metabolic Basic Science Research Metabolic diseases Clinical trial data Medical Monitoring Regulatory Interactions Clinical Study Reports +26

Senior Mid Full Time

USD 196K+

Director, Safety Scientist
Remote (US), United States

Medical Safety Assessment Signal Assessment Safety Data Evaluation Pharmacoepidemiology Global Regulatory Requirements CTA Safety Assessment Product safety IND +57

Exec Senior Full Time

USD 181K+

Specialist, Global Regulatory Affairs (GRA) Brands Chemistry, Manufacturing & Controls (CMC)
United States Remote Office, United States

Documentum CTD CMC ICH Regulatory Submissions Regulatory Affairs Controls Oral communication Chemistry +17

Entry Senior Full Time

USD 41K+

Clinical Research Physician
US: USA Remote, United States

Eli Lilly and Company

Electronic Data Capture Consultative Support Medical Monitoring Good clinical practices Medical research Obesity Scientific Expertise Site Management Volunteerism +23

USD 213K+

Clinical Research Physician Pain
US: USA Remote, United States

Eli Lilly and Company

Analgesic Research Phase 2 Studies Multicenter Trials Electronic Data Capture Consultative Support Medical Monitoring Good clinical practices Medical Documentation Medical research +28

USD 252K+

Principal Scientist – Device Technical and Engineering Lead (Director Equivalent)
USA - New Jersey - Rahway, United States

Manufacturing process development Automated assembly Human factors analysis Quality system regulation Injection molding Human factors guidance EN 62366 Device technology Combination product development +75

Senior Full Time

USD 149K+

Clinical Research Medical Director, Inflammation
US - Illinois - Chicago - Field/Remote, United States

Key Opinion Leader Development Basic Science Research Global Strategy Clinical trial data Medical Knowledge Regulatory Interactions Scientific Knowledge Product Lifecycle Biopharmaceutical Industry +33

Exec Mid Full Time

USD 256K+

Associate Principal Scientist – Device Technical and Engineering Lead (Associate Director Equivalent)
USA - New Jersey - Rahway, United States

Automated assembly Human factors analysis EN 62366 Human factors guidance Quality system regulation Device technology Combination product development Human factors Manufacturing Process +73

Senior Mid Full Time

USD 135K+

Senior Regulatory Affairs Specialist
Tennessee, Virtual Address, United States

Marketing compliance Stakeholder training Regulatory intelligence Marketing materials Labeling Product Lifecycle Regulatory strategy Regulatory Submissions Functions +14

Senior Mid Full Time

USD 75K+

Staff Biostatistician
US Remote

JMP Applied Statistics Statistical Methodology Statistical Concepts NGS Next-Generation Sequencing Biomarkers Molecular diagnostics Orientation +34

Senior Full Time

USD 155K+

Director, Regulatory Affairs - CMC
Remote - United States, United States

Bristol Myers Squibb

NDA DMF MAA Health Authority Responses Quality Module CTA Radiopharmaceuticals IND Analytical Methods +16

Exec Senior Full Time

USD 204K+

Director, Biostatistics - Late Stage Oncology
US - NJ - offsite, Estados Unidos

Gilead Sciences

Sample size calculation Infrastructure Development ICH Guidelines Clinical Trial Design Biostatistics Regulatory Submissions Therapies Drug Development SAS +24

Exec Senior Full Time

USD 201K+

Senior Medical Director
Remote Opportunity

Research initiatives Clinical Pharmacology Clinical Trial Design Regulatory Submissions Drug Development Clinical Development Biotechnology Clinical trials Oncology +2

Senior Full Time

USD 250K+

Medical Director
Remote Opportunity

Research initiatives Research Programs Clinical Pharmacology Clinical Trial Design Regulatory Submissions Drug Development Clinical Development Biotechnology Clinical trials +3

Exec Mid Full Time

USD 234K+

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

Inferential analyses Simulations Biomarker analyses Multivariate analyses Exploratory analyses CDASH Clinical trial protocols Statistical analysis plans SDTM +27

Senior Full Time

USD 115K+

Senior Associate, Medical Writing Business Operations
US - CA - offsite

Gilead Sciences

Scientific review Virology Medical Writing Regulatory Submissions Therapies Regulatory Affairs Drug Development Diversity and Inclusion Vision +18

Senior Mid Full Time

USD 104K+

Senior Scientist BioSeparations
USA - New Jersey - Rahway

BioSeparations Filtration Systems Viral Clearance Downstream process development Digital twins Downstream processing Industry 4.0 JMP Facility fit +79

Senior Full Time

USD 111K+

Senior Scientist, Biostatistics, Early Development Statistics
USA - New Jersey - Rahway

Experimental medicine Scientific Principles Research decision sciences Regulatory Approval Statistical Methodology Clinical Pharmacology Early clinical development Product Discovery Biomarkers +57

Senior Mid Full Time

USD 111K+

Sr Regulatory Affairs Specialist
Remote California

IEC Standards FDA guidance AI/ML technologies ISO Standards Algorithm Development Continuous Glucose Monitoring Health Technology Mobile applications ISO +24

Senior Full Time

USD 87K+

Cybersecurity Specialist
United States of America : Remote

Security governance Quality Management Systems Mitigation Industry Best Practices Quality Management System Regulatory Submissions FDA Diabetes Care Cross-functional Teams +24

USD 83K+

Medical Director
USA - Remote

Clinical/anatomic pathologist Clinical chemist Immunoassays Clinical pathologist In vitro diagnostics Clinical Laboratory Laboratory Diagnostics Adverse event reporting Flow cytometry +22

Exec Mid Full Time

USD 285K+

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