- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** _Strategic Leadership and Project ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality. + Provide Voice of Manufacturing input to early… more
- Burns & McDonnell (Conshohocken, PA)
- …risk assessments that evaluate impacts associated with rules implemented by regulatory agencies. + Reviews financial analysis completed by consultants ... help clients make decisions backed by business and engineering analysis . The senior consultant will directly engage with clients...engineering or business and 6 years of experience or PhD in Engineering or Business and 5 years of… more
- ICON Clinical Research (Blue Bell, PA)
- …+ Oversee statistical activities that support ICON's interactions with clients and regulatory agencies + Review and approve statistical methods sections of study ... protocols, statistical analysis plans, and statistical input to reports + Program...create new guidance **Your profile:** + Master's degree OR PhD in Biostatistics, Statistics, or a related field +… more
- J&J Family of Companies (Spring House, PA)
- …House, PA or Cambridge, MA, under the mentorship of Dr. Matthew J. Loza, PhD , Director, Johnson & Johnson. Translational Sciences and Medicine (TSM) is an integrated ... target centric indication sequencing and prioritization, and biomarker support of regulatory filings. The group has expertise in biomarker development, disease… more
- PNC (Pittsburgh, PA)
- …accuracy of reported results and provide expertise in all financial statement and regulatory reporting matters. The Senior Tax Accounting Manager reports to the Tax ... review and/or calculation of income tax provision accrual and analysis , including effective income tax rate, deferred income tax...and review of the income tax portion of the regulatory reporting process including projections of income tax expense… more
- Merck (West Point, PA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Merck (North Wales, PA)
- …entire cycle of clinical development, including study design, placement, monitoring, analysis , regulatory reporting, and publication. Specifically, the Director ... Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data Analysis , Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory… more
- Merck (West Point, PA)
- …challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- Cytel (Harrisburg, PA)
- …Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study ... Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies. + Writes the statistical sections… more
- Merck (West Point, PA)
- …oversee analytical investigations with a strong focus on quality and regulatory compliance. + Excel in impurity isolation, unknown peak identification, ... leadership and collaboration. + Maintain a deep understanding of the regional regulatory and business environment, including: + API and Drug Product development… more