... region or globallyOversee and coordinate Regulatory Affairs Specialists to achieve submission targets ... clientsServe as representative of Global Regulatory Affairs at business development meetings Qualifications: ...
... achieve. We are currently seeking Regulatory Affairs Professionals with experience in Clinical ... client projects as a Senior Regulatory Affairs Consultant, Regulatory Affairs Consultant or Regulatory Affairs Senior Associate. We offer Parexel ...
... -complexity Phase II-IV clinical regulatory documents.We´ll trust you ... , Safety Narratives, ICFs, Efficacy Summaries, Regulatory responses, etc.,) your contribution will ... Masters)Minimum 4 years of regulatory medical writing experience, including at ...
... development of high complexity clinical regulatory documents that are critical to ... coordinate development of complex clinical regulatory documents including Clinical Study Protocols, ... in CTD eCTD format for regulatory submissions world-wide.Strategist.This ...
... by directing the Company’s financial affairs, within a framework of prudent ... .Oversee all tax and financial regulatory compliance issues including the preparation ... ).High level of tax and regulatory knowledge.Fluent in English and ...
... treatments. From clinical trials to regulatory, consulting, and market access, our ... (s), GCP, and the applicable regulatory requirement(s).Ensure quality. Evaluate ... the completeness and quality of Regulatory Documentation and perform site document ...
... trial deliverablesEnsure appropriate communication, regulatory documentation, and ongoing oversight of ... high quality oversight of monitoring, regulatory, IP, site payment and overall ... GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ...
... to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. ... Procedures Work Instructions (SOPs WIs); regulatory directives: study specific plans and ... , relevant Precision Oncology SOPs, and regulatory guidance, as well as the ...
... treatments. From clinical trials to regulatory, consulting, and market access, our ... clinical documents for submission to regulatory authorities, including but not limited ... advances in medical writing and regulatory issues.- Develop and train Medical ...
... , including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs Safety, to support milestone achievement ...