Manager, Quality Systems
data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits. Coordinate quality system elements, training...
Lugar: North Chicago, IL | 01/02/2025 18:02:46 PM | Salario: S/. No Especificado | Empresa: AbbVie
Senior Manager, Biostatistics
deliverables comply with regulatory guidelines (FDA, EMA, ICH, etc.) and company SOPs. Contribute to the preparation of regulatory...
Lugar: Marlborough, MA | 01/02/2025 18:02:18 PM | Salario: S/. $138400 - 173000 per year | Empresa: Lifelancer
Senior Clinical Project Manager
United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the... of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA...
Lugar: Cambridge, MA | 01/02/2025 18:02:05 PM | Salario: S/. $138754 - 187726 per year | Empresa: Akebia Therapeutics
Senior Manager, Pharmacovigilance Operations Excellence
inspections, and PV audits Working knowledge and understanding of global regulations for safety and PV including FDA, EMA...
Lugar: Cambridge, MA | 01/02/2025 18:02:40 PM | Salario: S/. No Especificado | Empresa: Lifelancer
Regulatory Consultant, US based, 2-3 years of Submissions & Project Management
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards..., 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter...
Lugar: Bridgewater, NJ | 01/02/2025 18:02:18 PM | Salario: S/. No Especificado | Empresa: Lifelancer
Principal Statistical Programmer
/GRAPH. Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA...
Lugar: Cambridge, MA | 01/02/2025 03:02:25 AM | Salario: S/. No Especificado | Empresa: Katalyst Healthcares & Life Sciences
Medical Assistant - Dermatology
-oriented environment Ability to problem solve and be proactive Experience with electronic medical record systems, EMA...
Lugar: Plymouth, MA | 01/02/2025 02:02:43 AM | Salario: S/. $17 per hour | Empresa: Quadrant
Manager, Analytical Development (Protein Sciences)
global product release within the quality management system adhering to FDA, EMA, MHRA, TGA and other ROW Regulatory agency...
Lugar: Philadelphia, PA | 01/02/2025 00:02:14 AM | Salario: S/. No Especificado | Empresa: Iovance Biotherapeutics
Principal Scientist (In-Vivo), Oncology
. Experience in writing technical drafts for patent filings, IND (US-FDA) or CTA (EMA) filings are desirable. Johnson & Johnson...
Lugar: Spring House, PA | 01/02/2025 00:02:24 AM | Salario: S/. No Especificado | Empresa: Johnson & Johnson
Technical Writer
and maintenance of documentation best practices. Stay up-to-date with industry regulations and guidelines (e.g., FDA, EMA...
Lugar: San Diego, CA | 31/01/2025 23:01:40 PM | Salario: S/. $80000 - 100000 per year | Empresa: PSC Biotech