... of study milestones; conducting operational team meetings at regular intervals with CRAs, Documentation Specialists and others as needed; attend relevant symposia, conferences and scientific meetings as necessary; ensuring that company SOPs, GCPs and ICH guidelines are adhered to; contributing to training activities and process improvement in Clinical Operations and participation in other tasks as needed. The ideal candidate will have the ...

... to reflect these changes in compliance with relevant regulations, guidance documents, and SOPs. Provides input into the creation and review of Data Management related SOPs, best practices, working guidelines and other quality template documents. Ensures that the Data Management teams comply with ICH/GCP regulations, guidance documents and SOPs. Who you are: You’re someone who wants to ...

..., compensation analysis, survey analysis); roll out programs and present materials. -Provide compensation training to end-users. -Perform all duties in accordance with the firms Business Principles, corporate directives, SOPs and PPGs, government and industry regulatory guidelines. -Consistently demonstrate ACTION culture and behaviors. -Perform other tasks requested by management. Qualifications: -Typically requires a Bachelor’s degree...

...personal and departmental relationships with the business • Perform other tasks as requested by management • Perform all duties in accordance with the firm’s Business Principles, corporate directives, SOPs and PPGs, and government and industry regulatory guidelines. • Consistently demonstrate ACTION culture and behaviors. Qualifications: • Typically requires a Bachelor’s degree in a related ...

... and maintaining records of patient test result; 2. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens; 3. Analyze specimens using approved testing procedures (see department SOPs). 4. Review and release test results. 5. Follow CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines. 6. Adhere to the laboratorys quality control policies, document all ...

...: the development of appropriate understanding of DSS case processing, required DSS and company SOPs, coding conventions, etc. and development expert technical understanding of the relational design and structure... aggregate regulatory reports and Phamacovigilance activities, understanding of Drug Safety processes (including relevant SOPs, WDs), documentation, requirements, and organization, basic understanding of products, clinical Safety subject ...

... and maintaining records of patient test result; 2. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens; 3. Analyze specimens using approved testing procedures (see department SOPs). 4. Review and release test results. 5. Follow CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines. 6. Adhere to the laboratorys quality control policies, document all ...

... and maintaining records of patient test result; 2. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens; 3. Analyze specimens using approved testing procedures (see department SOPs). 4. Review and release test results. 5. Follow CLIA, HIPAA, OSHA, and safety guidelines as described in their respective guidelines. 6. Adhere to the laboratorys quality control policies, document all ...

... and distribution industry seeks a Fulfillment Lead to oversee the assembly process for our drug sampling and literature fulfillment programs, ensuring that all assembly areas, materials, and personnel conform to cGMPS, SOPs and PSOPs. Qualified candidate must have 2+ years of warehouse production/fulfillment experience, with a minimum of 1 year supervisory experience. Should be detail oriented with good computer skills, specifically in MS Excel....

... clinical development, clinical trial design, protocol development, managing the writing of clinical sections of regulatory submissions, or management of industry-sponsored clinical trials . Understanding of drug development process, SOPs, GXP and applicable regulations, and designated therapeutic/clinical systems . Experience with FDA regulatory submissions, FDA inspections, management, preparation, response, and 483s . Bachelors degree from an ...