- Lilly (Indianapolis, IN)
- …trial data + Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy ... Plan, database, and observed datasets) + Support submission, inspection and regulatory response activities + Lead cross Business Unit/Therapeutic Area projects or… more
- Fujifilm (Indianapolis, IN)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Fujifilm (Indianapolis, IN)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Lilly (Indianapolis, IN)
- …with the medical vision and comply with current regulations, laws, guidance (eg FDA , ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and ... collaboration with cross-functional partners including medical affairs, clinical operations, regulatory , statistics and data science to advance the oncology pipeline… more
- Sumitomo Pharma (Indianapolis, IN)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Lilly (Indianapolis, IN)
- …of cGMP requirements in medical device manufacturing. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Excellent ... documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs,… more
- Sumitomo Pharma (Indianapolis, IN)
- …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
- Norstella (Indianapolis, IN)
- …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
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... considerable on-the-job experience + Direct interaction with Client and Regulatory Auditors + Lead and guide all tours related...issues real-time + Executes other duties as assigned + Drug Substance + Equivalent technical expertise of process and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and Qualifications * Expertise in pharmaceutical engineering, including cGMP and FDA /USP/OSHA regulatory requirements. * Proven experience developing and leading ... (value: $10M- $150M), ensuring adherence to budget, schedule, quality, and regulatory standards. * Oversee the design, construction, and commissioning of new… more