- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Pulmonary Disease Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance, Regulatory Compliance, Scientific… more
- Astrix Technology (Monmouth County, NJ)
- …quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs , clinical development, and biostatistics. + Interpret and ... Pharmacy, Medicine, or a related field; advanced degree (MS, PhD , PharmD, MD) preferred. + Minimum of 3 years...in medical writing with a focus on pharmacovigilance or regulatory affairs . + Strong knowledge of drug… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs . + ... Participate in intellectual property growth; submit patent applications and Invention Disclosure Records. + Works under general direction and independently determines or develops approach to solutions. + Adhere to Good Laboratory Practices, all relevant lab… more
- J&J Family of Companies (Raritan, NJ)
- …including ensuring in-stream data quality from partners. + Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents ... all assets within Heme, ensuring alignment with overall clinical development and regulatory activities. + Serve as the primary point of accountability for diagnostic… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
- Bristol Myers Squibb (Princeton, NJ)
- …plan (IDP) in partnership with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug ... maximize program impact + Actively supports Investor Relations and Public Affairs in managing external BMS communications **Integrates commercialization inputs and… more
- Bristol Myers Squibb (Princeton, NJ)
- …the BrCa space + Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... in high quality scientific, technical or medical journals **Qualifications** : + PhD degree in a relevant field (eg molecular biology, cancer biology, human… more
- J&J Family of Companies (Raritan, NJ)
- …degree, or PhD in life science, analytical science, data science, regulatory compliance or regulatory affairs , computer science, mathematics, statistics, ... students pursuing Bachelor (Rising Juniors or above), Masters, and PhD who desire a career in the medical device...analysis tools + Awareness of quality management systems or regulatory requirements **FOR US ONLY:** Applicable pay range: $23… more
- Sanofi Group (Morristown, NJ)
- …work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the ... of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities + Collaborate… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more