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51 fresh jobs found

Sr. Director of Global Sterility Assurance & Microbiology (Solventum)
Remote - Minnesota

Solventum Remote-first

X-Ray Sterilization VHP E-Beam Sterilization EO Sterilization Gamma Sterilization Sterility Assurance Steam Sterilization Medical Device Sterilization Validation Processes +37

Senior Full Time

USD 259K+

Sr Clinical Trial Design & Development Manager
Remote

Personalized medicine Protocols Clinical Trial Design Cell-free DNA Orientation Collection Genetic Testing Regulatory Submissions Regulatory standards +30

Senior Full Time

USD 114K+

PET Advanced Application Specialist
Remote

Radiochemistry Site qualification Automated synthesizers Radiopharmaceuticals Pharmaceutical diagnostics Medical Imaging Pharmaceutical manufacturing PET Technology Transfer +28

Senior Mid Full Time

USD 93K+

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd)

CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50

Senior Full Time

USD 181K+

Principal Scientist-Biologics Potency, Cell Based Sciences, AR&D
USA - New Jersey - Rahway

Reporter gene assays NK cell assays GxP potency assays Biologics potency assays Cell line engineering Large molecule portfolio Scientific mentoring Mechanism-of-action assays Binding assays +60

Senior Full Time

USD 149K+

Associate Director of Regulatory Affairs
Remote Opportunity

MHRA EMA Regulatory operations Communication Planning Global Regulatory Strategy Regulatory Guidelines Regulatory Submissions Stakeholder Collaboration Regulatory Affairs +8

Senior Mid Full Time

USD 152K+

Principal Scientist, Engineering
USA - New Jersey - Rahway

Chroma Downstream processing Viral Clearance Performance qualification BLA MS Process Characterization Process Performance Therapeutics +65

Senior Full Time

USD 164K+

Senior Manager, Regulatory Diagnostics
Remote (US)

ECTD CTD Regulatory Documentation Regulatory Guidance Protocols Regulatory strategy ICH Guidelines Regulatory knowledge Adobe Acrobat +31

Senior Full Time

USD 135K+

Principal Biostatistician FSP, Neuroscience
Durham, North Carolina, United States of America

Causal inference methods Rare disease methods Bayesian techniques Synthetic control arms Epidemiologic data Exploratory analyses CDASH Clinical trial protocols ICH GCP +25

Senior Full Time

USD 131K+

Senior Specialist of Regulatory Operations
Remote Opportunity

Publishing Systems MHRA Technical editing EMA FDA Submissions End-User Training Regulatory operations Quality review SOP Development +6

Senior Full Time

USD 117K+

Undergrad Intern - Regulatory Affairs (Obesity)
US - California - Thousand Oaks - Field/Remote

Obesity Regulatory Documents Office Software Toxicology Evidence Generation Documentation Management Regulatory Submissions Inflammation Biology +26

Entry Internship Full Time

USD 56K+

Regulatory Affairs Director - Global Regulatory Lead
US - California - Thousand Oaks - Field/Remote

Data Sheet Development Clinical trial applications Product Labeling Marketing Applications Global Regulatory Strategy Regulatory expertise Obesity Global regulations Life cycle management +35

Senior Full Time

USD 188K+

Principal Biostatistician FSP, Pharmacokinetics
Durham, North Carolina, United States of America

PK PD Biomarker analysis Exploratory analyses Biomarker analyses Multivariate analysis Multivariate analyses CDASH Clinical trial protocols +25

Senior Full Time

USD 131K+

Senior Manager, Clinical Operations
Remote (United States)

PTC Therapeutics, Inc.

Data consistency Expenditure oversight Investigator meetings Clinical Monitoring Data Flow Clinical Strategy Clinical Study Reports Protocol Development ICH Guidelines +13

Senior Full Time

USD 135K+

Senior Scientist, Small Molecule Analytical Research & Development (Onsite)
USA - New Jersey - Rahway

Synthetic small molecule Drug delivery technologies Oligonucleotide Design of experiment Peptide Predictive analytical tools Novel technologies Oligonucleotides Analytical methodologies +67

Senior Full Time

USD 111K+

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

In-process controls Drug Product Commercialization Facility fit Shelf-life strategies Packaging strategy Site characterization Multivariate analysis CMC regulatory strategy Manufacturing science +85

Senior Full Time

USD 164K+

Principal Biostatistician FSP, Immunology
Durham, North Carolina, United States of America

Exploratory analyses CDASH Multivariate analyses Biomarker analyses Clinical trial protocols ICH GCP CDISC SDTM ADaM +23

Senior Full Time

USD 131K+

VP, Chief Medical Safety Officer
Remote US

Medical Safety Scientific Leadership Clinical Oversight FDA regulations Workflow Regulatory Submissions Electrophysiology Regulatory Affairs Cardiology +13

Exec Senior Full Time

USD 287K+

Senior Manager, Regulatory Affairs, CMC
Remote (US)

EU Regulatory Requirements Technical Document Authoring Microsoft 360 ICH Requirements US Regulatory Requirements Regulatory strategy Protocols CMC Financial excellence +23

Senior Full Time

USD 133K+

U.S. Regulatory Affairs Senior Manager
US - California - Thousand Oaks - Field/Remote

Product Labeling Legislation Awareness Regulatory policy Global Regulatory Strategy Regulatory research Regulatory Documents Regulatory Guidance Regulatory strategy Labeling +26

Senior Full Time

USD 139K+

Director, Quantitative Pharmacology and Pharmacometrics (Remote)
USA - Pennsylvania - West Point

Model-Based Strategies ADME Clinical drug development Model-Based Approaches Mathematical problem solving Clinical trial simulations Biopharmaceutics PK/pD strategies Pharmacodynamics +82

Exec Senior Full Time

USD 181K+

Director, Quantitative Pharmacology and Pharmacometrics (Hybrid)
USA - Pennsylvania - West Point

Model-Based Strategies ADME Clinical drug development Model-Based Approaches Mathematical problem solving Clinical trial simulations PK/pD strategies Biopharmaceutics PharmD +84

Exec Senior Full Time

USD 181K+

Director, Statistical Innovation
US - Maryland - Baltimore -Field/Remote

Adaptive design WinBUGS Advanced statistical methods Bayesian Methods Scientific research Biopharmaceutical Industry Payer Publications Clinical Trial Design +33

Exec Senior Full Time

USD 210K+

Medical Director – Early Clinical Development, Oncology
US - California - Thousand Oaks - Field/Remote

Translational science Basic Science Research FDA guidelines Medical Monitoring Regulatory Interactions Spotfire Insight Publications Clinical Data +35

Exec Mid Full Time

USD 251K+

Associate Principal Statistical Programmer - Oncology (Hybrid)
USA - New Jersey - Rahway

Statistical Terminology SAS/Macro SAS/Graph Reporting processes Programming Algorithms Clinical Trial Programming Programming Standards Regulatory Approval Research decision sciences +67

Senior Mid Full Time

USD 135K+

Principal Scientist, Cell Culture & Fermentation Sciences
USA - New Jersey - Rahway

Fermentation Sciences Fermentation Mathematical modeling Performance qualification Drug substance Mammalian cell culture IND Manufacturing Investigations Process Performance +89

Senior Full Time

USD 164K+

Principal Biostatistician FSP, Cardiovascular
Bloomington, Illinois, United States of America

Exploratory analyses Multivariate analyses CDASH Biomarker analyses Clinical trial protocols Statistical analysis plans SDTM ADaM ICH GCP +22

Senior Full Time

USD 131K+

FSP Principal Biostatistician-Early Phase Oncology
Durham, North Carolina, United States of America

Multivariate analyses Clinical trial protocols Biomarker analyses CDASH Bayesian Methods ADaM Statistical analysis plans ICH GCP SDTM +23

Senior Full Time

USD 122K+

FSP Principal Biostatistician - RWE in Neuroscience
Bloomington, Illinois, United States of America

Clinical trial protocols ICH GCP Observational Research Health Economics Real-World Evidence Analytic Biostatistics Regulatory Submissions ICH +19

Senior Full Time

USD 131K+

Senior Manager, Regulatory Affairs IVD & CDx
Remote - United States

Submission Management International regulations Biomarker strategies IVD Commercialization Regulatory Submissions Regulatory Affairs Clinical Development Medical device +5

Senior Full Time

USD 145K+

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

Scale-Up Processes Drug Product Commercialization Characterization Studies Life cycle management CMC regulatory strategy Performance qualification QbD principles Manufacturing science Process Performance +93

Senior Mid Full Time

USD 135K+

Associate Principal Scientist Statistical Programming- Oncology, PKPD- Hybrid
USA - Pennsylvania - North Wales (Upper Gwynedd)

SAS/Macro SAS/Graph S-Plus Programming Algorithms Clinical Trial Programming Programming Standards SAS programming Nonmem Applied Mathematics +56

Senior Mid Full Time

USD 135K+

Technical Writer (remote)
USA-MN Mounds View Central

Medical Device Standards Labeling Localization Regulatory Submissions Content development Medical device Technical Writing Product Development Quality Assurance +10

USD 97K+

Technical Writer (Remote)
USA-MN

Medical Device Standards Labeling Localization Regulatory Submissions Content development Medical device Technical Writing Product Development Quality Assurance +10

USD 97K+

Sr. Regulatory Manager
Remote

Software as a medical device ISO 15189 CAP ISO 14971 ISO 13485 Quality Management Systems FDA regulations CLIA Genomics +17

Senior Full Time

USD 145K+

AVP/Section Head, Metabolism - Global Clinical Development
USA - New Jersey - Rahway

Metabolic disorders Medicine Commercialization Regulatory Submissions Executive Presence Pharmaceutical Industry Operational Drug Development Influence +32

Exec Senior Full Time

USD 326K+

Biostatistics Associate Director
US - California - Thousand Oaks - Field/Remote

Operational efficiencies Clinical Study Reports Publications Regulatory Guidelines Pharma Study Design Biostatistics Regulatory Submissions Strategy Development +30

Senior Mid Full Time

USD 173K+

Executive Director, Device Quality & Regulatory
USA - New Jersey - Rahway

QMSR Regulatory Submission Quality oversight Regulatory CMC Health authorities Device technology IND BLA Device development +66

Exec Senior Full Time

USD 243K+

Senior Medical Writer
United States of America : Remote

Scientific Publication TAVI Quality System Environment Clinical Study Report Writing Clinical data analysis KOL management Regulatory Submission Implantation Clinical Strategies +26

Senior Full Time

USD 72K+

Associate Director, Global Regulatory Project Management and Strategic Planning - GI²
USA - MA - Virtual

Integrated Project Planning Health Authority Submissions Global Regulatory Strategy Logistical Support Operational Support Regulatory Submissions Cross-functional Leadership Pharmaceuticals Regulatory Affairs +20

USD 149K+

Associate Principal Scientist, Engineering
USA - Pennsylvania - West Point

Manufacturing Investigations Scale-down QbD Current good manufacturing practices Tech Transfer Regulatory Filing Process Characterization DOE Process Validation +83

Senior Mid Full Time

USD 135K+

Principal Scientist, Engineering
USA - Pennsylvania - West Point

Intravitreal product development Performance qualification Site characterization Manufacturing Investigations Packaging strategy Shelf-life strategies CMC regulatory strategy Multivariate analysis Tech Transfer +79

Senior Full Time

USD 164K+

Clinical Research Medical Director - Cardiology/Heart Failure, US - Remote
US - California - Thousand Oaks - Field/Remote

Cardiovascular disease EMEA regulations Basic Science Research Clinical trial data Pharmaceutical Product Development International regulatory requirements Regulatory Interactions Metabolic Patient reported outcomes +42

Exec Mid Full Time

USD 256K+

Senior Medical Director, Pharmacovigilance, Gastrointestinal and Inflammation (Remote)
USA - MA - Virtual

Benefit-risk assessment Medical Safety Signal detection Pharmacovigilance Regulatory Submissions Pharmaceuticals Pharmaceutical Industry Drug Development People Management +17

Senior Full Time

USD 256K+

Senior Regulatory Affairs Specialist
US Remote

QSR experience GMP Compliance ISO 9000 Acrobat ISO Standards FDA regulations Medical Technology AutoCAD Regulatory Submissions +12

Senior Full Time

USD 100K+

Quality Senior Manager
US - California - Thousand Oaks - Field/Remote

Imaging Methods Vendor Qualification Biosimilars Quality Metrics Quality by Design CAPA Global regulations Inspection Readiness Protocol Development +41

Senior Full Time

USD 144K+

Director, Translational Medicine and Early Development (Clinical Pharmacology Lead)
USA - Pennsylvania - Plymouth Meeting

Biomarker Strategy Modeling and Simulation Pharmacodynamics Translational Medicine Clinical Pharmacology Pharmacokinetics Study Design Biostatistics Regulatory Submissions +8

Senior Full Time

USD 150K+

Clinical Research Medical Director – Endocrinology/Obesity , US - Remote
US - California - Thousand Oaks - Field/Remote

EMEA regulations Basic Science Research International regulatory requirements Clinical trial data Pharmaceutical Product Development Observational Research Publications Metabolic Regulatory Interactions +43

Exec Mid Full Time

USD 256K+

Clinical Research Medical Director, Oncology
US - California - Thousand Oaks - Field/Remote

EMEA regulations Basic Science Research Lung cancer International regulatory requirements Clinical trial data Pharmaceutical Product Development Observational Research Medical Monitoring Publications +41

Exec Mid Full Time

USD 256K+

Clinical Research Medical Director, Thoracic Oncology
US - California - Thousand Oaks - Field/Remote

Lung cancer Key Opinion Leader Development International regulatory requirements Clinical trial data Pharmaceutical Product Development Observational Research Medical Monitoring Regulatory Interactions Publications +39

Exec Mid Full Time

USD 256K+

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