- System One (Rahway, NJ)
- Job Title: Associate Principal Scientist , Regulatory Affairs Location: Rahway, NJ (Hybrid) Hours/Schedule: Mon- Fri; 8am- 5pm Type: Contract ... Responsibilities The Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned… more
- Merck (Rahway, NJ)
- …biologics, and pharmaceutical products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize an ... to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The...a member of the ADC drug product team, the Associate Principal Scientist will have… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology ... and/or combination product space. + In-depth knowledge of medical device development, regulatory requirements, and quality standards, with a proven track record of… more
- Merck (Rahway, NJ)
- …& Product Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and utilize advanced ... and cGMP environments is highly desired. Familiarity or experience with regulatory filings (BLAs, NDAs) and CMC processes preferred. + Experience with… more
- Merck (Rahway, NJ)
- …ensure products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements. This position will lead ... and influence clinical and commercial combination product development and launches. ** Principal Responsibilities** + Lead and set direction for the device… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for… more
- Merck (Rahway, NJ)
- **Job Description** The **Executive** **Clinical Director (Distinguished Principal Scientist )** has primary responsibility for the strategic planning and ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Executive Clinical Director… more
- WuXi AppTec (Plainsboro, NJ)
- …training for subordinates and/or less experienced staff. + Assists in training Associate Scientist . + Laboratory Maintenance + Follows company's safety policies, ... **Overview** With supervision serve as study director/ principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects.… more
- Atlantic Health System (Summit, NJ)
- …obtain data for use in the diagnosis and treatment of disease. Principal Accountabilities: 1. Demonstrates proficiency and follows testing procedures and policies by ... revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP,… more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Clinical Director (Sr. Principal Scientist )** has primary responsibility for the strategic planning and directing clinical ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May… more