- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... The Senior Manager , Centers of Excellence (CoEs) is responsible for...to enterprise-wide business excellence initiatives as needed. **Team & Project Support** + May supervise or mentor junior staff… more
- Edwards Lifesciences (Pittsburgh, PA)
- …journey. The primary objective of **the Outreach and Physician Education Program Manager ** is to execute Transcatheter Heart Valve's (THV's) vision to ensure the ... that are in need and meet the requirements for treatment. The **OPE Manager ** will support the Provider Engagement and Strategic Sales Programs Team, with an… more
- Edwards Lifesciences (Harrisburg, PA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- FirstEnergy (Reading, PA)
- …& Regulatory Team reporting to the Vice President of Finance and Regulatory Affairs for Pennsylvania. The primary onsite office location for this role ... of business partners. Oversee team in day-to-day processes, including cost/ project management and compliance activities. Provide growth opportunities for analysts… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partner with Regulatory Affairs in planning, coordination, writing, and execution of ... preferred + Working knowledge of Windows, Microsoft Office, E-mail, and Microsoft Project + Excellent oral and written communication skills + Well organized, detail… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... new product introduction, design control process and lifecycle management + Strong project management skills + Proven ability to resolve complex issues, solve… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core… more
- University of Pennsylvania (Kennett Square, PA)
- …high-energy environment. Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise in animal ... CORL Study Director New Bolton Center Job Profile Title Manager Research Project C Job Description Summary...Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise… more
- University of Pennsylvania (Philadelphia, PA)
- …and manage study data and regulatory files per GCP. + Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform ... protocols and documents. + With the help of the project manager , manage/coordinate/organize the daily work of... regulatory files per GCP. + Work with Regulatory Affairs Specialist to prepare for audits,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs , medical writing, data management) to translate ... Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs - as well...completed on time, within budget, and in compliance with regulatory guidelines. + Design statistical analysis plans for clinical… more