- Insmed Incorporated (NJ)
- …for documentation review prepared by other technical functions and will act as the primary regulatory contact for the US FDA. The GRL will be accountable for ... regulatory submissions, communications, and negotiations with global Health Authorities for designated products. Title/Level will be determined upon evaluation of credentials and experience.What You'll Do: Lead development and execution of global regulatory… more
- Formation Bio (New York, NY)
- …(GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice President of Quality Assurance are to ... develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development activities at Formation Bio. As a tech enabled development organization, there is a… more
- Cipla (Fall River, MA)
- …(scope, cost and time) deliverables for Cipla projects. Operate as the primary liaison and project manager on Internal /external partnerships of Cipla North ... America. Responsible for delivery on the projects to agreed and planned scope, time, cost and quality. Operate as the single point of contact for Cipla internal stakeholders on all aspects of projects. Internal stakeholders include but limited to executive… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …at CROs; review protocols, monitor studies, and interpret data.Serve as the primary toxicology subject matter expert for interactions with regulatory agencies (FDA, ... EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, immunogenicity, insertional mutagenesis, and long-term safety.Participate in the… more
- Cipla (Fall River, MA)
- …level of I, II and III depends on year of experience in the discipline. The primary nature of this job is to serve as a Warehouse Operator. As a secondary ... requirement, this position will be expected to provide support to other operational functions to include but not limited to Packaging Operations, Manufacturing Operations, and Facilities Operations. Job Description : The Warehouse Operator performs all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The primary responsibilities of the Director, Omni-Channel Marketing is to develop, plan and ... implement the overall omni-channel marketing strategy to key customer segments across the portfolio in partnership with brand teams. The incumbent should assess external digital opportunities and threats as key inputs to decisions on business strategy given… more
- Texas Childrens Hospital (Houston, TX)
- …for ten consecutive years. Texas Children's comprehensive health care network includes our primary hospital in the Texas Medical Center with expertise in over 40 ... first HMO focused on children; Texas Children's Pediatrics, the largest pediatric primary care network in the country; Texas Children's Urgent Care clinics that… more
- Texas Childrens Hospital (Houston, TX)
- …for ten consecutive years. Texas Children's comprehensive health care network includes our primary hospital in the Texas Medical Center with expertise in over 40 ... first HMO focused on children; Texas Children's Pediatrics, the largest pediatric primary care network in the country; Texas Children's Urgent Care clinics that… more
- Texas Childrens Hospital (Houston, TX)
- …for ten consecutive years. Texas Children's comprehensive health care network includes our primary hospital in the Texas Medical Center with expertise in over 40 ... first HMO focused on children; Texas Children's Pediatrics, the largest pediatric primary care network in the country; Texas Children's Urgent Care clinics that… more
- ChristianaCare (Newark, DE)
- …Thursday, 7:00 am to 7:00 pm and Friday 7:00 am to 4:30 pm Primary function: To provide Physical Therapy for individuals requiring rehabilitation after injury or ... disease process. Principal Duties and Responsibilities: Evaluate and re-evaluate patients in a timely manner. Establish appropriate treatment programs that include goals to be attained in a timely manner. Complete all documentation relating to patient care,… more
