- Organon & Co. (Jersey City, NJ)
- …Pharmacology function in asset development teams (ADT) across the portfolio including drug candidates and lifecycle management (LCM) for mature products or be ... 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to… more
- Parexel (Trenton, NJ)
- …in the industry and assist our clients in the journey of getting new and innovative drug treatments into the hands of those who need them most. You will be a member ... with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA indication and… more
- Taiho Oncology (Princeton, NJ)
- …clinical research and drug development, including experience as medical monitor and (sub) investigator on a clinical oncology trial. + At least 2 years in drug ... documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report...protocols, IB, ICF, CSR. + Working knowledge of the drug development process in the USA and EU is… more
- Bayer (Whippany, NJ)
- …design, execution, and oversight of the clinical development programs of diagnostic drug Molecular Imaging (MI) assets in Radiology. This role encompasses clinical ... + Represent Clinical Development Radiology for Molecular Imaging diagnostic drug assets globally; + Ensure effective collaborations between capabilities overseeing… more
- Bristol Myers Squibb (Princeton, NJ)
- …prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance ... the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs. + Supports priorities within functional area.… more
- Sumitomo Pharma (Jersey City, NJ)
- …key competitive information to aid the clinical and marketing teams in drug /brand development. + Identify, initiate, coordinate, evaluate and monitor investigator ... products. + Help develop and manage timelines of publication plans of investigator -sponsored studies. + Assist in the identification, evaluation, and engagement of… more
- Taiho Oncology (Princeton, NJ)
- …documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and publications. + Reviews and ... be considered. Knowledge, Skills, and Abilities: + 3-5 years of experience in clinical drug development in pharmaceutical industry. + At least 2 years in drug … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …clinical development plans. + Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in ... landscape and standards of care. + Build and maintain strong KOL, investigator , and partner relationships; represent Otsuka and OPDC at scientific, clinical, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …(including Medical Affairs Sponsored studies, clinical research collaborations, investigator -sponsored studies and select health outcomes studies) associated with ... Global Medical and International Medical Teams, Research & Discovery, Global Drug Development (GDD), Health Economics & Outcomes Research (HEOR), Global Biometric… more
- Sanofi Group (Morristown, NJ)
- …Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings + Answer to medical questions raised by HA, ... Review and/or contribute in the clinical section of the Investigator 's brochure, CTA, IND, DSUR, DRMP, RMP + Contribute...field. MPH or Biomedical Science master combined with extensive drug development experience may be considered + At least… more