- Catalent Pharma Solutions (Manassas, VA)
- …holidays **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 ... Handler** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop,… more
- Parexel (Richmond, VA)
- …and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. ... Writing Services management. + Provide support as appropriate to Business Development /Client Solutions and Medical Writing Services management in their efforts to… more
- Parexel (Richmond, VA)
- …**Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, eg, ... searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical… more
- Parexel (Richmond, VA)
- …LIMS (Laboratory Information Management System) experience + Working knowledge of the clinical drug development process + Working knowledge of the Food & ... Drug Administration (FDA) regulations, International Council for Harmonization (ICH)...Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT). + Oncology experience… more
- Parexel (Richmond, VA)
- …and a go-getter mindset. Experience in **RWD/RWE** , **data privacy** , and ** drug development ** is a plus. **Career Growth:** Shape new services, mentor ... go-getter mindset. + Knowledge of **RWD/RWE methodologies** , data privacy, and drug development processes. + Ability to thrive in dynamic environments and lead… more
- Humana (Richmond, VA)
- …and help us put health first** The Clinical Pharmacist Lead monitors drug development pipeline, and medical literature, while providing clinical support ... professional, and clinical activities for the purposes of pharmacy program development for our Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP)… more
- Parexel (Richmond, VA)
- …FDA, EMA, and Health Canada (IND, NDA, DMF) * In-depth understanding of drug development , manufacturing processes, GMP, and regulatory frameworks for small ... regulatory strategy input for small molecules (previous experience with biologics and/or drug -device combination products are a plus) * Support regulatory leads in… more
- Guidehouse (Arlington, VA)
- …pharma and/or biotech clients. + Strong understanding of the pharmaceutical industry, including drug development and launch. + The ability to analyze complex ... project dependent but averages 20 percent. The Life Sciences practice encourages career development and hiring for the long term. Senior Consultants follow a clearly… more
- Sumitomo Pharma (Richmond, VA)
- …Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to ... to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on… more
- Parexel (Richmond, VA)
- …PromoMats, GLAMS. Competencies: * Deep understanding of regulatory requirements for drug development , global labeling, and post-marketing. * Strong ... of global labeling. Key Responsibilities: * Manage internal global labeling and drug safety activities and coordinate bi-weekly updates with leadership. * Coordinate… more