Sr Medical Writer (Regulatory)
... members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing ...
... members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing ...
... members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing ...
... continuous manufacturing, data analytics, and regulatory compliance to join our innovative ... manufacturing techniques Familiarity with regulatory requirements and quality standards including ... e.br., JMP, R, Python) Regulatory experience and knowledge of FDA ...
... We translate unique clinical, medical affairs and commercial insights into outcomes ... projects involving integrated analyses, attend regulatory agency meetings or respond to ... applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains ...
... We translate unique clinical, medical affairs and commercial insights into outcomes ... projects involving integrated analyses, attend regulatory agency meetings or respond to ... applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains ...
... to implement process improvements.Assure regulatory compliance and technical feasibility of ... as requested by QA and Regulatory Affairs including the annual report required ... Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S ...
... . We translate unique clinical, medical affairs and commercial insights into outcomes ... on-site or remotely) ensuring regulatory, ICH-GCP and or Good ... ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer ...
... internal SOPs, policies and local regulatory requirements. Supports the local study ... staff to ensure accurate complete regulatory documents are in place to ... Distributes, collect, review, and track regulatory documents, agreements and training documentation. ...
... . We translate unique clinical, medical affairs and commercial insights into outcomes ... applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains ...
... internal policies, industry standards, and regulatory requirements. Oversee the monitoring of ... , ISF, etc.). Good knowledge of regulatory requirements (e.g., DORA, GDPR, ...