- Cardinal Health (Austin, TX)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Sumitomo Pharma (Austin, TX)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Austin, TX)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Austin, TX)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Abbott (Austin, TX)
- …including global, regional, and local markets, field sales force, technology, legal, regulatory , medical affairs , public affairs , executive management, ... + **Background** : remains current on developments in field(s) of expertise, clinical data, healthcare economics and reimbursement, regulatory requirements, and… more
- Pfizer (Austin, TX)
- …asset cross-functional committees, as appropriate + Represent Pfizer Medical Affairs leadership with clinical /professional associations and/or societies, ... as appropriate + Understand the priorities of Pfizer Medical Affairs in order to contribute to Medical educational content...the designated therapeutic area + Provide education on the clinical and economic impact of Pfizer to help inform… more