- Parexel (Tallahassee, FL)
- …+ Ability to work on complex tasks requiring in-depth evaluation + Good knowledge of drug safety and the drug development process + Ability to exercise ... documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness of global… more
- Parexel (Tallahassee, FL)
- …with specialized therapeutic expertise and some experience across indications, clients and drug development . They initiate and maintain medical and consultative ... and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration… more
- Parexel (Tallahassee, FL)
- …as contracted across multiple channels and interactions such as: --Consultancy on protocol development , drug development program etc. --Medical review of ... but not essential - A background in clinical aspects of drug development , including all aspects of Medical Monitoring and study design/execution, preferred… more
- Parexel (Tallahassee, FL)
- …ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management ... timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for… more
- Parexel (Tallahassee, FL)
- …+ Bachelor's Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, ... tracking of labeling updates + Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory… more
- Parexel (Tallahassee, FL)
- …ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management ... timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for… more
- Parexel (Tallahassee, FL)
- At **Parexel** , we don't just support drug development -we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll ... draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A Senior/Vice… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... trials, clinical sciences, medical monitoring, target product profile (TPP) development , due diligence projects, and clinical-regulatory compliance. ResponsibilitiesEssential Duties… more
- Parexel (Tallahassee, FL)
- …techniques and interpret results + Familiarity with regulatory/research guidelines on drug development , GCP, and statistical principles (especially ICH ... + Provide broad statistical support, including trial design, protocol and CRF development on specific studies + Lead production and quality control of randomization,… more
- Parexel (Tallahassee, FL)
- …FDA, EMA, and Health Canada (IND, NDA, DMF) - In-depth understanding of drug development , manufacturing processes, GMP, and regulatory frameworks for small ... regulatory strategy input for small molecules (previous experience with biologics and/or drug -device combination products are a plus) - Support regulatory leads in… more
