- Sumitomo Pharma (Trenton, NJ)
- …Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard ... Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product...Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …+ Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic ... standard practice, compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance...landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH and GCP guidelines as well as… more
- Norstella (Trenton, NJ)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Taiho Oncology (Princeton, NJ)
- …safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance. + ... safety reports. + Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc. + Chairs the GSMT for responsible… more
- Cardinal Health (Trenton, NJ)
- …with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- AbbVie (Jersey City, NJ)
- …reports, assessment reports, medical safety assessments) in accordance with regulatory requirements and procedures, and in collaboration with cross- functional ... + Applies solid knowledge and understanding of applicable regulations (eg, ICH, FDA , EMA,GCP) to independently lead authoring and review of all safety deliverable… more
- Merck (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, ... assembly and disassembly, cleaning, and processing of raw materials into finished drug product. These individuals are expected to partner with and support… more
- Catalent Pharma Solutions (Princeton, NJ)
- …and ensure audit readiness. + Maintain compliance with SOPs and regulatory requirements ( FDA , EMA, cGMP) by documenting results, supporting ... improvement initiatives. This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures (SOPs).… more
- Cardinal Health (Trenton, NJ)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Cytel (Trenton, NJ)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… more