- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(eCTD) format. + Experience with international clinical trials and regulatory documentation. + Experience interacting with FDA representatives and organizing ... on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory … more
- Merck (Rahway, NJ)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance ... Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA , EMA, MHRA, and Health Canada… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Caris Life Sciences (New York, NY)
- …responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position ... clinical database. + Support and adhere to Good Clinical Practices (GCP) guidelines, FDA , Institutional Review...years of experience in data collection activities within a GCP/ clinical research regulatory environment. + Knowledgeable in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Act as the primary point of contact for cross-functional teams, including R&D, clinical operations, regulatory affairs , quality assurance, and marketing. + ... needed. Regulatory Compliance: + Ensure all project activities comply with FDA , EMA, and other relevant regulatory authorities' guidelines and regulations. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... + Excellent statistical knowledge and project planning skills + Knowledge of clinical trial research and regulatory requirements + Familiarity with SDTM/AdaM… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... medicine studies. + Collaborates with cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory , PK/ADME, Pharmacovigilance,… more
- Pfizer (New York, NY)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs \#LI-PFE ... + Manage cross-functional Labeling Team and collaborate with stakeholders including Clinical , Medical, Safety, Regulatory , and Commercial + Drive global… more