- Insmed Incorporated (San Diego, CA)
- …clinical and scientific support to clinical development and operations, regulatory, medical affairs , drug safety, and quality assurance teams, as well as overall ... program support ensuring adherence to all standard operating procedures (SOPs).What You'll Do: Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Collaborate with internal teams, contract research… more
- Insmed Incorporated (NJ)
- …trackers, and regulatory archives.Partner with cross-functional teams (Regulatory Affairs , CMC, Clinical, Quality) to facilitate document authoring, review, ... approval, and publishing workflows.Conduct technical checks (validation, bookmarking, hyperlinking) to ensure submissions pass regulatory agency gateways.Support lifecycle management of submissions, including post-approval supplements, variations, and periodic… more
- Insmed Incorporated (NJ)
- …closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and biostatistics.Provide medical ... leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical… more
- AUROBINDO (Durham, NC)
- …expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we have a ... robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewThis position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses… more
- Insmed Incorporated (NJ)
- …vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program advancement. You ... will also provide technical expertise and due diligence support for business development opportunities.This role offers the opportunity to make a significant impact on our small molecule pipeline while leading a talented team in a dynamic biopharmaceutical… more
- Syner-G BioPharma Group (Boston, MA)
- …management.Collaborate with internal stakeholders including EHS, IT, and Regulatory Affairs to support compliance and operational goals.Develop and maintain SOPs, ... maintenance logs, and documentation for inspections and audits.Support regulatory inspections and ensure compliance with OSHA, EPA, NFPA, and local building codes.Lead root cause analysis and resolution of facility-related incidents and system failures.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo Inc's Oncology Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to ... work closely with the Director of Publications Operations to optimize department resources for delivery of high-quality medical publications in an efficient and compliant manner. They will assist in the operation and governance of iEnvision, an internal global… more
- Insmed Incorporated (NJ)
- …Are:Advanced degree required (PharmD, PhD, MD, NP-C).6+ years of Medical Affairs experience required including direct experience within Field Medical beneficial (3 ... years).Understanding of adult learning methodologies and training development required.Deep understanding of US market and the ability to develop knowledge in assigned therapeutic areas and products required.Forward looking professional with a continuous… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date knowledge of evolving regulatory ... guidelines and scientific advances in CGT toxicology.Has authority and should have the ability to make decisions on preclinical toxicology strategies and execution planRequirementsPh.D., DVM, or equivalent in Toxicology, Pharmacology, or related field. DABT… more
- AUROBINDO (Durham, NC)
- …expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we have a ... robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewThe Inhalation Scientist / Engineer is responsible for metered dose inhaler (MDI) pre-formulation, formulation,… more
