Senior Regulatory Submission Project Management Specialist
regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc). Knowledge and practical experience in...
regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc). Knowledge and practical experience in...
into the Central Nervous System (CNS penetrant) that has received Orphan Medicinal Product Designation from the EMA... Authorization Application (MAA) has been validated and is currently being reviewed by the EMA’s Committee for Medicinal Products...
with participants, including collect anthropometric, survey data, ecological momentary assessment (EMA) data, video-recorded meals...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...
to all applicable regulatory requirements for license and labels, including FDA, EMA, Wholesale Distribution Authorization (WDA... with local and international regulations, including FDA, EMA, and other relevant regulatory agencies Provide guidance...
to all applicable regulatory requirements for license and labels, including FDA, EMA, Wholesale Distribution Authorization (WDA... with local and international regulations, including FDA, EMA, and other relevant regulatory agencies Provide guidance...
patient care. Dermatology experience preferred, experience with EMA/ModMed preferred. This person must be able to demonstrate...
, EMA). Excellent analytical, problem-solving, and decision-making skills. Strong communication and interpersonal skills...
situations. Medical office experience required. EMA/ModMed experience preferred. Responsibilities include but are not limited...