compliance best practices. Experience writing or managing SOPs within a regulated industry (e.g., healthcare, pharmaceuticals...-paced environment Travel will be required to Alnylam's headquarters in Cambridge, MA....
documents supporting regulatory submissions About Alnylam: AlnylamPharmaceuticals (Nasdaq: ALNY) has led the translation... Pharmacology and Pharmacometrics capabilities within Alnylam. The Executive Director, Pharmacometrics is a on-site, leadership...
Develop and follow good programming practices, including adequately documenting SAS and R code;Perform, plan and coordinate project work to ensure timely, quality delivery across multiple projects;Provide input into, or lead general stand...
Contribute to data management activities as a lead study data manager in support of Alnylam clinical studies...
Develop, implement, and oversee Alnylam's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8..., and adjust to changing priorities in a fast-paced environment Effectively manage and develop others to be successful at Alnylam...
Technology Transfer & Scale-Up: Lead due diligence, process scale-up, optimization, and technology transfer activities for new drug product manufacturing at CMOs. Process Design & Control: Define process control strategies by establishing r...
Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership. Build knowledgeable and skilled team with competencies and capabilities to successfully set up and delive...
In partnership with FP&A and Suppliers and Study Management, ensure accurate, transparent, and timely financial analyses to support Clinical Operations accruals;clearly articulate financial implications from variances between forecast and ...
Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership. Build knowledgeable and skilled team with competencies and capabilities to successfully set up and delive...
Manager, Clinical Operations is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial...