... development. Study Start Up Associate Regulatory Submissions - Dutch Speaker We are ... clinical trials, ensuring compliance with regulatory requirements, and contributing to the ...
... , oversight, and impact on local regulatory and financial compliance, at a ... , the local ethics, legislation and regulatory environment, submission and approval processes, ... and sites, IRB IECs and Regulatory Authorities to ensure country deliverables ...
... in data management, biostatistics, regulatory affairs, and medical affairs as ... final documents. Adheres to established regulatory standards, including but not limited ... current industry practices and regulatory requirements and guidelines that affect ...
... clinical documents for submissions to regulatory authorities globally. Works directly with ... 2 summary documents, and other regulatory documents. Role will be for ... 2 summary documents, and other regulatory documents. Strong proficiency in Word, ...
... : 5- 6 years experience in regulatory medical writing, 4 of which ... clinical documents in support of regulatory submissions globally (ie multiple regions). ... clinical study report development process, regulatory and drug safety requirements, and ...
... Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I ... to according to the applicable regulatory requirements. • Ensure the integrity of ... EC submissions, notifications to regulatory authorities, translation of study-related ...
... Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I ... to according to the applicable regulatory requirements. • Ensure the integrity of ... EC submissions, notifications to regulatory authorities, translation of study-related ...
... submissions, integrated analyses), and attend regulatory agency meetings or responds to ... SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains ... to CSR. • Experience with regulatory submissions preferred. • Excellent written and ...
... submissions, integrated analyses), and attend regulatory agency meetings or responds to ... SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains ... to CSR. • Experience with regulatory submissions preferred. • Excellent written and ...
... in data management, biostatistics, regulatory affairs, and medical affairs as ... final documents. Adheres to established regulatory standards, including but not limited ... current industry practices and regulatory requirements and guidelines that affect ...