Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA. Contribute to protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation Ph.D. in Pharmacokineti...
Support business requirements gathering processes across all Patient Services teams, Case Management and Patient Education Liaisons (PELs) and Business Units (TTR and RARE). Provide initial smoke testing and feedback to Strategic Technologi...
, pharma or at a CRO preferable. Excellent English oral and written communication skills. Strong interest in areas of Alnylam...
as Alnylam's liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned product(s), including preparing... documents, and enforcement actions Contribute to culture of compliance at Alnylam by educating colleagues on the regulatory...
Cambridge, MA NE 3 - AlnylamPharmaceuticals / Full-Time / Hybrid The Senior Project Controls Analyst leads...
Cambridge, MA NE 3 - AlnylamPharmaceuticals / Full-Time / Hybrid The Project Controls Analyst provides...