Get new jobs by email
- Bioequivalence Expert Pharmaceutical Consultant Join to apply for the Bioequivalence Expert Pharmaceutical Consultant role at Pharmavise Corporation Bioequivalence Expert Pharmaceutical Consultant 3 days ago Be among the first 25 applicants Join to apply for the Bioequivalence...SuggestedContract workRemote work
- ...laboratory operation.Develop and validate analytical methods to quantify drugs and metabolites in biological matrices to support bioequivalence and other pharmacokinetics studies with supervision.Document laboratory activity in accordance with established procedures....SuggestedFull timeLocal areaWorldwide
- ...particle size, aerodynamic performance (NGI/ACI), spray geometry, viscosity, osmolality, and related physical chemistrySupport Bioequivalence strategy development, including, IVIVC, biowaiver arguments, and Q1/Q2/Q3 sameness justificationsAnalyze and interpret experimental...SuggestedFull timeWorldwide
- ...responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications. Lead, guide, and train the CMC team to ensure...SuggestedLocal area
$69.56k - $73k
...using OOS/OOT and LIMS Perform in-vivo dissolution test related to the biopharmaceutic characteristics of the drug substance and bioequivalence studies using cGMP/cGLP, Empower, Titration, HPLC, dissolution Perform solubility studies of drug substances as per Bio-...SuggestedFull time$201k - $393.8k
...SupportDesign and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include...SuggestedLocal areaFlexible hours$121k - $220k
...productsProvide medical and clinical interpretation underpinning labeling positions and ensure fair balance with the underlying clinical or bioequivalence datasetTranslate labeling positions into North American (U.S. and Canada) Core Medical Content so MSL tools, medical...SuggestedFull timeFor contractorsWorldwide- ...1 studies and standard clinical pharmacology package studies (e.g., First in Human, Drug-to-Drug Interaction, Bioavailability/Bioequivalence).Proven ability to independently lead global Phase II and/or Phase III clinical trials.Strong experience managing CROs, central...SuggestedContract workRemote work
- ...Practices (GLPs), and Standard Operating Procedures (SOPs). The position oversees the testing of pre-commercial release samples or for bioequivalence studies (BE) in accordance with cGMPs, GLPs, and SOPs. Essential Duties and Responsibilities Plan and supervise the analytical...SuggestedWork experience placementWork at office
$306k
..., including ADME, drug-drug interactions (DDIs), pharmacokinetics/pharmacodynamics (PK/PD), exposure-response, bioavailability/bioequivalence, and other studies required to characterize dose, regimen, safety, and efficacy.Oversee drug metabolism, pharmacokinetics, bioanalysis...SuggestedRemote workFlexible hours- ...audits and inspections Maintain veterinary master files and product registration databases Generic Product Expertise Guide bioequivalence and biowaiver strategies for generic veterinary products Collaborate with R&D for comparative study strategies and analytical...SuggestedFull time
$145k - $165k
...generic products. The Manager partners closely with Research & Development, Analytical Development, Manufacturing, Quality, Clinical/Bioequivalence, Supply Chain, Project Management, and external development and manufacturing partners to facilitate timely regulatory...SuggestedFlexible hours$285k - $305k
...decisions. Plan, design, oversee, and interpret clinical pharmacology studies, including first-in-human, relative bioavailability/bioequivalence, food-effect, QT, drug-drug interaction, and organ impairment studies. Apply innovative model-informed drug development (MIDD)...SuggestedWork at officeLocal area$148.5k - $257.4k
...more biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA) and experience establishing IVIVC/IVIVR or bioequivalence safe spaces.Knowledge of formulation development and physical pharmacy of small molecules, including poorly soluble compounds...SuggestedTemporary workImmediate startFlexible hours$130.5k - $211.2k
...teams to define and integrate them.Translate model outputs into decision-ready arguments — including device-bridging strategies, bioequivalence assessments, and delivery-system design recommendations — to support regulatory discussions.Communicate modeling assumptions,...SuggestedLocal areaFlexible hours$208.06k - $262.15k
...National Regulatory Authorities (NRAs), pharmacovigilance (PV), post-market surveillance systems, and clinical study capacity for Bioequivalence/Bioavailability (BE/BA) trials.Be a thought partner to other leaders within the GHMS team as we collectively advance USP’s...Full timeWork experience placementWork at officeWorldwide- ...analytical data and insights. He/she will advance fundamental understanding of drug release and product performance by developing the bioequivalence safe space and/or IVIVC using physiologically based biopharmaceutics modeling through close collaborations with clinical...Full time
$23 per hour
...along with dermatology products including prescription topical creams and ointments that require sophisticated formulation and bioequivalence approaches. In addition, the Durham facility supports development of transdermal delivery systems, nasal sprays, and other complex...Temporary workWork at officeFlexible hoursShift workWeekend workAUROBINDO
Durham, NCa month ago
