- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical … more
- Kennedy Krieger Institute (Baltimore, MD)
- **Overview** The Project Manager (Accreditation and Regulatory Affairs ) will support accreditation and regulatory functions of Kennedy Krieger Institute ... to ensure continuous compliance with federal, state, and local regulatory requirements including but not limited to, The Joint Commission (TJC), Centers for Medicare… more
- Veterans Affairs, Veterans Health Administration (Washington, DC)
- …to the next lower grade level is required for all GS-12 assignments. Clinical Laboratory Scientist (Quality Manager ), GS-12. In addition to the experience ... program materials, which ensure accreditation and compliance with all regulatory agencies concerning patient testing, result reporting, and proficiency testing.… more
- Veterans Affairs, Veterans Health Administration (Baltimore, MD)
- Summary The Biomedical Equipment Support Specialist provides clinical and administrative support to staff, patients, and administrators for all matters of concern ... to provide lifecycle management and technical support to improve clinical care provided by doctors, nurses, and other ...functional knowledge of relevant safety codes and standards of regulatory bodies including, but not limited to, The Joint… more
- Veterans Affairs, Veterans Health Administration (Washington, DC)
- …and data. Serves as a VHA Governance Board SharePoint Web Content Manager and ensures pertinent GB documents, which influence the VHA's governance structure, ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
- Johns Hopkins University (Baltimore, MD)
- …at an academic, government, or pharmaceutical industry environment. + Requires experience in clinical research and regulatory affairs . Experience in protocol ... Under limited supervision of the Sr. Clinical Research Program Manager , we are seeking a **_Clinical Research Regulatory Specialist_** who will be… more
- Amgen (Washington, DC)
- …of more senior staff. **Responsibilities:** + Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs , and ... response technology (IxRS) specifications + Collaborate with project management, regulatory , medical affairs , PV/safety, business development, and commercial… more
- Johns Hopkins University (Baltimore, MD)
- …of lab/research staff. + Regulatory and Safety which will oversee the regulatory and QI/Safety activities across the clinical divisions of the Department of ... and experience with integrated academic health care systems and in clinical practice management. Classified Title: Sr. Administrative Manager Role/Level/Range:… more
- Takeda Pharmaceuticals (Annapolis, MD)
- …relationships among functions represented at the Labeling cross functional teams including clinical , safety, medical affairs , device regulatory and ... therapies to patients worldwide. Join Takeda as the Senior Manager , Global Labeling Devices. You will be responsible for...as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global… more
- Edwards Lifesciences (Annapolis, MD)
- …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
- Amgen (Washington, DC)
- …the lives of patients while transforming your career. **Global Advocacy Relations Senior Manager (Oncology)** **What you will do** Let's do this! Let's change the ... world! In this vital role, the Oncology Senior Manager of Global Advocacy Relations at Amgen is responsible...focused solutions in the design and development of our clinical development programs + Creates engagement opportunities for patients… more
- Fujifilm (Annapolis, MD)
- …+ 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
- Amgen (Washington, DC)
- …and US Medical, US Business Units, Global Product Teams, Government Affairs , Healthcare Policy, Clinical Development, Health Economics/Outcomes Research, Value ... transform the lives of patients while transforming your career. **Advocacy Relations Senior Manager , Bone Health** **What you will do** Let's do this! Let's change… more
- Catalent Pharma Solutions (Harmans, MD)
- …plans. This position reports directly to the Senior Vice President of Quality & Regulatory Affairs and will have strong working relationships with VP General ... accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance for the Maryland campus....Manager Maryland and other Site Leadership team members. Working… more
- Koniag Government Services (Silver Spring, MD)
- …+ Certifications or specialized training in areas such as medical writing, regulatory affairs , or scientific communication + Strong presentation and public ... via email only and have not been interviewed by the KGS hiring manager , feel free to contact_ _KGSrecruiting@koniag-gs.com_ _to verify its validity._ **Koniag IT… more
- CSL Plasma (Halethorpe, MD)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... appropriate physician the duties of "laboratory director", "technical consultant", or " clinical consultant" as prescribed by the Clinical Laboratory Improvement… more