- Actalent (Somerset, NJ)
- …Additional Skills & Qualifications + Capable of writing comprehensive reports for regulatory submissions with minimal supervision. Work Environment This role is ... analytical issues to achieve desired results. + Write reports suitable for regulatory submission with minimal supervision. + Perform other duties as assigned.… more
- Actalent (Mahwah, NJ)
- …regulated industry experience preferred . Experience in preparing technical reports for regulatory submissions is desirable . The candidate is expected to ... as required by the audience, up to and including that necessary to support a regulatory submission Pay and Benefits The pay range for this position is $50.00 -… more
- System One (Mahwah, NJ)
- …regulated industry experience preferred. + Experience in preparing technical reports for regulatory submissions is desirable. Benefits System One offers eligible ... by the audience, up to and including that necessary to support a regulatory submission. Requirements + A minimum of BS degree in Materials Science/Engineering (other… more
- J&J Family of Companies (Raritan, NJ)
- …reports, source documentation and filing sections to support product lifecycle and regulatory submissions + Create, maintain, and upgrade product technical ... plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today… more
- Merck (Rahway, NJ)
- …+ Proven track record of authoring and providing critical input to the regulatory submissions including but not limited to Investigational New Drugs, ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Bristol Myers Squibb (Princeton, NJ)
- …evaluating competitive differentiation, and supporting internal decision-making and regulatory submissions . Experience in virtual population development ... mechanistic models to support clinical study design, dose selection, and regulatory strategy * Engage external collaborators to accelerate modeling efforts in… more
- Eliassen Group (Trenton, NJ)
- …the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements ... transparency and informed decision-making. **Experience Requirements:** + Experience with regulatory environments and submissions requirements for compliance in… more
- Merck (Rahway, NJ)
- …figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- System One (Plainsboro, NJ)
- …consent forms, Investigator Brochures (IBs), safety updates, study reports, and regulatory submissions . + Support data management processes, including case ... report form (CRF) development and data review. + Lead development of Medical Data Review Plans (MDRPs) and perform ongoing review of clinical data for safety and efficacy. + Provide scientific input on country and site selection, feasibility assessments, and… more
- Merck (Rahway, NJ)
- …in other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures ... and associated documentation. + Ensure programmatic traceability from data source to analysis/modeling result. Support the development of programming standards to enable efficient and high-quality production of programming deliverables. **Educational… more