- Seattle Children's (Seattle, WA)
- …part 11 validation and compliance. Recognized certification in Quality Assurance or Regulatory Affairs . Proven audit experience in GCP. **Compensation Range** ... and leadership to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research. Leads overall business planning and… more
- Lundbeck (Deerfield, IL)
- …open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the ... and development products/programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC,… more
- Teleflex (Morrisville, NC)
- …extensive cross-functional collaboration with Marketing Communications (MarCom), Product Marketing, Clinical and Medical Affairs , Legal/Compliance, Regulatory ... / Product Managers - Marketing Directors - Marketing Communications - Clinical and Medical Affairs - Legal - Regulatory - Corporate Brand Management… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are conducted in ... . **Job Description** This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and… more
- BeOne Medicines (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... readiness quality, within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external partners working on the regional… more
- Terumo Medical Corporation (Somerset, NJ)
- …ID: 5279 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Clinical Affairs Terumo Medical Corporation (TMC) develops, manufactures, and ... 14155 / 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and… more
- Teleflex (San Francisco, CA)
- …ensuring an optimal customer experience. Collaborating with Marketing, Sales, Engineering and Clinical & Medical Affairs on key projects and initiatives, the ... Clinical Sales Specialist, Vascular, San Francisco or Oakland...relevant policy and procedures, evidence-based practice guidelines and mandated regulatory requirements. Working closely with healthcare providers and their… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …to potential impacts. + Lead through Internal Collaboration: Forge strong collaborations with clinical development, medical affairs , and regulatory teams to ... ensure seamless integration of Access strategies into overall product development and market access plans + Lead in External Agency Management: Provide hands-on oversight and guidance on Market Access and pricing related agency selection and management,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting ... the clinical project team during all stages of a ...and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... and compliance for the design, manufacture, and service of clinical and research products. Primary Responsibilities: The Global Vice...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
