- Norstella (Harrisburg, PA)
- …life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is ... strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and ... in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role...patients. **Job Description** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream… more
- CSL Behring (King Of Prussia, PA)
- …including integrated analyses for submissions. + Represent Biostatistics in interactions with regulatory authorities (eg, FDA , EMA, PMDA) + Be responsible for ... program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the… more
- Globus Medical, Inc. (Eagleville, PA)
- …and other regulatory requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... The demonstrated ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes,… more
- Charles River Laboratories (Malvern, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. At Cell Solutions, we are passionate ... customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's… more
- Pfizer (Collegeville, PA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... qualified colleague/s, analyze the emerging safety profile of the drug , keeping the clinical and safety colleagues informed of...the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval +… more
- Norstella (Harrisburg, PA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... clients navigate the complexities at each step of the drug development life cycle -and get the right treatments...structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in… more
- Cardinal Health (Harrisburg, PA)
- …GDPR (General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), ... maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key… more
- WellSpan Health (York, PA)
- …and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding ... and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in… more
- Teva Pharmaceuticals (West Chester, PA)
- …and/or GMP quality experience preferred. + Solid understanding of legal and regulatory frameworks related to clinical research and drug development. + ... Compliance role reports into our Global R&D, Quality, and Regulatory Legal organization. This position will provide legal support...+ Past experience working for a health authority (eg, FDA , EMA) preferred. + Admission to practice law in… more