Sr Director, Biostatistics
statisticians. Has led phase 1 and phase 2 oncology studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development...
statisticians. Has led phase 1 and phase 2 oncology studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development...
, utilities, and systems comply with cGMP and global regulatory requirements, including FDA, EMA, and ISO standards. The... standards, including FDA, EMA, and ISO. Demonstrated experience with validation documentation, including authoring...
including, tablets, liquids, powders, chews and others, in compliance with cGMP, FDA and EMA regulations/guidelines. Mentor the... and conferences, applying acquired knowledge. Adhere to cGMP, GLP, GCP, FDA and EMA legislations and guidelines, whenever applicable...
exam rooms, dedicated medical assistant, EMA/EMR in place Compensation & benefits: Competitive package including...
Familiarity with ModMed, EMA, EMR preferred Understanding of HIPAA laws and guidelines Works well independently...
with the ability to manage multiple competing priorities Familiarity with regulatory guidance (ICH, FDA, EMA) and HTA...
, communication, and supervision on all technical issues. Strong knowledge of cGMP, FDA, EMA, and other international regulatory...
space - newly constructed office paired with a seasoned, highly capable dermatology team Efficient practice model - EMA/EMR...
and excisions Opportunity to incorporate cosmetic dermatology, if desired Established EMA / EMR systems See approximately 35-40...
/EMA preferred) Assist with general dermatology visits including skin checks, acne, rashes, lesion evaluations, biopsies...