Associate Director, Biostatistics
analyses for submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA...
analyses for submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA...
of medical front office experience and practice management software experience is required. EMA / Modernizing Medicine Practice...
, EMA, PMDA, and other health authorities). Cross-Functional Collaboration & Technical Leadership Partner with Quality...
Laboratory Practices, PV, FDA and/or EMA/MHRA regulations. Excellent communication skills, both verbal and written. Able to work... from start-up to large employers. Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA...
that meet both regulatory and company requirements. Maintains expertise on various regulations (FDA, EMA, ICH, etc.) Provides...
guidance) Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent) Experience...
characterization and PPQ readiness Ensure compliance with FDA, EMA, and ICH guidelines for process validation and lifecycle management...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent) Experience governing CMO/CDMO quality relationships...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...