Authority Jobs

advance the program to registration development and ultimately global Health Authority approvals, customer adoption, and payor reimbursement.Basic qualifications: More than 10 years of total related experience. 5 plus years leading cross-functional drug development teams with a focus in oncology. Exceptional ... More

relationships with partners and customers. 7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing ... risk mitigation plans. 8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed ... More

relationships with partners and customers. 7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing ... risk mitigation plans. 8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed ... More

requirements throughout project lifecycle. 2. Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle. 3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. ... More

requirements throughout project lifecycle. 2. Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle. 3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. ... More

e-publishing requirements throughout project lifecycle. 2.Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle. 3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 4.Identify ... More

e-publishing requirements throughout project lifecycle. 2.Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle. 3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 4.Identify ... More

needed. 14. Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities. 15. Lead the training and mentoring of internal and cross-functional team membersEducation (minimum desirable): Bachelor of Science in Pharmacy Bachelor of ... More

and partners. 6.Prepare for, facilitate and lead logistics for Health Authority (HA) PV inspections; assess results of pre-inspection preparation activities ... second language; second language a plus) Experience/Professional requirement:7+ years PV/clinical/industry/health authority experience; GCP/PV auditing experience a plus; 2+ years as ... More

including Visio and MS Project. 35 hours/week. Must also have authority to work permanently in the U.S. Dow Jones and ... experience in using Microsoft Office tools including Visio and MS Project. 35 hours/week. Must also have authority to work permanently ... More