- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring the ... and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality for complex clinical deviations and Serious Breaches. + Review… more
- Insight Global (Beachwood, OH)
- …and manage regulatory applications (FDA and other global agencies). - Clinical Execution & Oversight o Oversee clinical study activities including site ... records. o Author or support the development of clinical study reports, white papers, and regulatory ...Cross-Functional Collaboration o Work closely with product management, engineering, regulatory , and medical affairs to ensure alignment… more
- J&J Family of Companies (Irvine, CA)
- …https://www.jnj.com/medtech We are searching for the best talent for an **Associate Director , Project Management** ( ** Clinical Research)** to support our ... Build and maintain strong relationships with internal and external stakeholders, including clinical . Medical, Regulatory and R&D teams. + Ensure consistency,… more
- AbbVie (North Chicago, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other ... reputation as an industry leader. + Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug… more
- AbbVie (North Chicago, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other ... May represent AbbVie at key external meetings. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- AbbVie (Irvine, CA)
- …interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other ... area. May represent AbbVie at key external meetings. *Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-… more
- Takeda Pharmaceuticals (Boston, MA)
- …(eg project management, clinical monitoring, data management process, regulatory affairs , pharmacovigilance, etc.) to enable meaningful dialogue within ... and empower you to shine? Join us as the Director , Supplier Relationship Management (FSP) based in Cambridge, MA...process standardization and change management activities. + Work with Clinical Partner Outsourcing (CPO) team to ensure execution of… more
- BeOne Medicines (San Mateo, CA)
- …leadership team, provides strategic leadership, management, and/or mentorship to regional clinical study managers & regional clinical trial manager associates/ ... inspection readiness quality, within agreed timelines and budget + Leads regional clinical operations teams (including external partners working on a regional level)… more
- J&J Family of Companies (Irvine, CA)
- …Collaborations** + Work with business partners including but not limited to R&D, Clinical Research, Business Development, Regulatory Affairs , Quality & ... **Role Purpose** The Director will have medical affairs responsibility in providing therapeutic and clinical ...Clinical Leadership** + Lead the support for all clinical studies - both for regulatory purposes… more