- Organon & Co. (Plymouth Meeting, PA)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Merck (Trenton, NJ)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary ... responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices...aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and medical device combination… more
- Merck (West Point, PA)
- …and pharmaceutical products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics ... to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The...a member of the biologics drug product team, the Associate Principal Scientist will have… more
- Astrix Technology (North Wales, PA)
- ** Associate Principal Scientist (Epidemiology)** Clinical North Wales, PA, US Pay Rate Low: 58.67 | Pay Rate High: 71.43 + Added - 14/04/2025 Apply for Job ... and innovative animal-health products, is in search of an Associate Principal Scientist to join...selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs + Coordinate COA/PRO related sections… more
- Merck (West Point, PA)
- …within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the West Point, ... to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not… more
- Merck (West Point, PA)
- …Bioanalytics (PDMB) in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic ... exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist / principal investigator on toxicity studies, and executing PK/TK… more
- Merck (North Wales, PA)
- **Job Description** **Senior Principal Scientist , Precision Medicine, Immunology** Precision Medicine is an integral part of our Immunology Therapeutic Area. To ... aligned with the Precision Medicine goals for relevant programs/assets The Senior Principal Scientist is responsible for maintaining a strong scientific fund… more
- Humana (Trenton, NJ)
- …part of our caring community and help us put health first** The Principal Data Scientist uses mathematics, statistics, modeling, business analysis, and ... to transform high volumes of complex data into advanced analytic solutions. The Principal Data Scientist provides strategic advice and guidance to functional… more
- Merck (West Point, PA)
- …process enhancements, next generation process development, and authoring of regulatory submissions. Under the general scientific and administrative department ... functional area on cross-functional and cross-divisional teams. + Authors required regulatory and technical documentation. Ensures that processes are developed and… more
- Merck (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... data + Produce tables and graphics for inclusion in study reports and regulatory submissions + Ensure programmatic traceability from data source to modeling result +… more
- Merck (North Wales, PA)
- …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 (West Point, PA)
- …Standardizations + Support various biologics and/or vaccine post-marketed CMC regulatory submissions + Lead/support complex technical investigations and drive ... resolution of analytical technical issues + Lead strategic initiatives within departmental and cross-functional teams representing GQLMAS **Required** **Exp** **erience | Knowledge | Skills:** + In-depth expertise with separations techniques specifically HPLC,… more
- Merck (North Wales, PA)
- …unplanned statistical analyses. + 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. + Maintain and manage a project plan including resource forecasting. + Support the development of programming standards to enable efficient and… more
- Burns & McDonnell (Conshohocken, PA)
- **Description** Burns & McDonnell is seeking an Associate / Principal Engineer, Hydrogeologist, Scientist in a related field to join our successful team of ... capping, and other industry standard methods. + Strong working knowledge of regulatory frameworks, including CERCLA, RCRA, Section 401 and Section 404 permitting. +… more