- Eisai, Inc (Philadelphia, PA)
- …cognitive impairment due to Alzheimer's disease (AD) or mild AD. The Neurology Account Specialist (NAS) will be part of a diverse team of sales professionals who ... marketplace.Seek out mentorship to learn and build key sales skills. Qualifications: Specialist - ADBachelor's degree with 3+ years experience in two or more of:… more
- Parexel (West Point, PA)
- …are looking to fill a **Scientist 2 or 3 - Analytical Chemist Metrology Specialist ** position working as a full-time employee of Parexel FSP on long-term assignment ... position does not offer sponsorship** . **The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory… more
- Parexel (Trenton, NJ)
- …operations + Functional experience in a pharma or CRO environment in regulatory , medical, or marketing operations + FUSE system experience required **Knowledge and ... Skills** + Working knowledge of compliance guidelines on advertising and promotion + Basic understanding of process optimization and asset creation + Proficiency in computer applications, including Microsoft Office and Adobe Acrobat **Organizational Skills** +… more
- iCIMS (Trenton, NJ)
- …and compliance status. + Provide leadership and act as key stakeholder of regulatory and compliance initiatives (eg ISO 27001, SOC 2, GDPR, Tx-RAMP, etc.). ... Participate in associated audits as necessary. + DevelopKey Performance Indicators (KPI) and Key Risk Indicators (KRI) toensure compliance-related controls are operating to an acceptable tolerance level. + Strong understanding of security tools to support the… more
- Towne Park (Plymouth Meeting, PA)
- …welfare, and retirement benefits. This role is responsible for monitoring legal and regulatory changes in laws and aligning with the company's goals. This role will ... (PHR, SPHR, SHRM-CP, SHRM-SCP) preferred. + Certified Employee Benefit Specialist (R) (CEBS) or Certified Benefits Professional(R) (CBP) strongly preferred **Work… more
- CSL Behring (King Of Prussia, PA)
- …trust-based relationships with key investors across the US, including biopharma- specialist funds, generalist funds, and crossover investors. Lead non-deal roadshows, ... Q&A briefings, and ESG reports. + Translate complex scientific, regulatory , and commercial developments into clear, compelling investment narratives. **Financial… more
- Parexel (Trenton, NJ)
- …for studies including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and concerns are addressed ... review of various documents which might be audited by clients and regulatory agencies More generally in any client interactions: --Provide medical expertise and… more
- Parexel (Trenton, NJ)
- …transform scientific discoveries into new treatments. From clinical trials to regulatory , consulting, and market access, our therapeutic, technical, and functional ... **Knowledge And Experience** + Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in **Ophthalmology** ,… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Regulatory Specialist C Job Profile Title Clinical Research Regulatory ... roles and responsibilities of sponsors, vendors, clinical researchers, and government officials. Regulatory Affairs Specialist C will lead the coordination of… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and… more
- Cardinal Health (Trenton, NJ)
- …development programs and regulatory submissions. **_Job Summary_** The Senior Regulatory Specialist , Data Management & Governance for Medical Devices plays ... **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to enable… more
- University of Pennsylvania (Philadelphia, PA)
- …Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary Regulatory Affairs as a ... clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of… more
- Penn Medicine (Philadelphia, PA)
- …and respond to any necessary follow-up of both announced and unannounced regulatory body site visits. Responsibilities also include educating staff to hospital ... on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety outcomes. Develops, maintains, and documents… more
- Globus Medical, Inc. (Audubon, PA)
- …Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps ... abreast of regulatory procedures and changes. Recommends strategies for earliest possible...clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with… more
- Bausch + Lomb (Trenton, NJ)
- …conform to all applicable laws and regulations. **Responsibilities:** + Provides regulatory review and approval of advertising and promotional materials, new ... campaigns and launch strategies. + Implements regulatory strategies and solutions to assure all advertising and...all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and… more
- Bausch + Lomb (Trenton, NJ)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management ... (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics). **Responsibilities:** + Interpret Regulatory Authority policies, regulations and guidances and correctly apply… more
- Bausch + Lomb (Trenton, NJ)
- …of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across CMC and ... Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes. **Responsibilities:**… more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist -CC to facilitate, with minimal supervision ... organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal… more
- University of Pennsylvania (Philadelphia, PA)
- …oversee, train and mentor any reporting Regulatory Affairs Supervisor and/or Regulatory Affairs Specialist A/B/C. In this capacity, the Associate Director ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
