Responsible for the development, documentation, implementation, and maintenance of the company's P2P policies and procedures;continuously improving processes and procedures to deliver operational excellence Assess and articulate business r...
and critical raw materials for Alnylam programs in clinical development until programs transitioning to commercial stage according...
Randomization) Lead target finding and validation efforts in at least one therapeutic area of interest to Alnylam (e.g., metabolic...
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...
Design and conduct laboratory experiments, analyze results, and draw meaningful conclusions. Support downstream processing method optimization. Execution of oligonucleotide downstream processes to provide the research and in-house non-GMP m...
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...