- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory leadership on the ... approval for five medicines, we are always conducting new clinical trials, and we are working to create an...and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Medtronic (Annapolis, MD)
- …team is looking for a highly motivated and skilled individual to join our Clinical Research, Medical Science, and Regulatory Affairs Organization. In this role, ... develop presentations for advocacy to regulators. + . Works with project manager to maintain and update the Global Regulatory Policy SharePoint, including providing… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** Reporting to the Senior Manager , Regulatory Affairs , Microbiology, the Staff Regulatory Affairs Specialist is responsible for the ... devices and in vitro diagnostic devices in both domestic and international clinical markets. This position interfaces with multiple projects and functional teams… more
- Johns Hopkins University (Lutherville, MD)
- The Department of Otolaryngology is seeking a **_CO_** **_Clinical Nurse Manager_** the Clinical Nurse Manager collaborates with the Medical Director and Clinic ... development. In partnership with the Clinic Supervisor, the Nurse Manager provides oversight to the clinical staff...Environmental of Care. + Work with the JHH Regulatory Affairs Office, JHHS Compliance Office, JHU CPA, and Office… more
- Merck (Annapolis, MD)
- …Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of ... GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is fully informed… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …+ Reimbursement:submissions, payment issues, policy statements, HTA submissions + Medical/Scientific Affairs : clinical study development support and execution + ... **Job Description Summary** The HEOR Senior Manager for the Diagnostic Solutions business is accountable...BD while informing the broader scientific strategy with Medical Affairs . The HEOR BU resource is responsible for ensuring… 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 ... with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience… more
- TestPros (Silver Spring, MD)
- …Public Trust Clearance Job Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to an FDA project. The ideal ... regulatory requirements. + Collaborate with cross-functional teams, including Regulatory Affairs , Product Development, and Project Management, to ensure quality… more
- Edwards Lifesciences (Annapolis, MD)
- ** Manager , Medical Safety Officer - Transcatheter Heart Valve...heart of everything we do. As part of our Clinical Affairs team, you'll foster internal and ... external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance...and be part of our inspiring journey. As the Manager , Medical Safety Officer within our THV business unit,… more
- BioLife Plasma Services (Towson, MD)
- …customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to ... Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for...Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health… more
- Johns Hopkins University (Baltimore, MD)
- …General Internal Medicine (GIM) as well as acts as coordinator of Faculty Affairs for GIM. This position also provides support for the Associate Administrator, and ... Provide administrative support for various directors within the division (eg clinical directors, research director, program director, and fellowship director) as… more
- CSL Plasma (Halethorpe, MD)
- …appropriate physician the duties of "laboratory director", "technical consultant", or " clinical consultant" as prescribed by the Clinical Laboratory Improvement ... for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides training to other… more
- Bayer (Baltimore, MD)
- …coordinated cross-functional approach. The ARAD will provide support to key accounts for clinical , operational and financial aspects of our products. The goal is to ... and conduct business reviews with relevant stakeholders and support accounts on Clinical , Financial and Operational topics related to Bayer's product portfolio; +… more
- Merck (Annapolis, MD)
- …align with customer needs and business priorities + Partner with Regional Sales Manager to develop and execute effective business strategy to reach and exceed ... priorities for lasting success + Meet with key opinion leaders in both clinical and university settings to discuss our company's portfolio as well as potential… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position reports directly to the Senior Vice President of Quality & Regulatory Affairs and will have strong working relationships with VP General Manager ... with other functional leaders (Product Development, Operations, etc.) and Site General Manager to develop and maintain a meaningful and robust Quality and Patient… more