- Cardinal Health (Washington, DC)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- 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
- Merck (Rockville, MD)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… 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)
- …a qualified and experienced Medical Technologist who serves as the Quality Assurance Manager at the Washington DC VA Medical Center, Pathology & Laboratory Medicine ... of the organization as it applies to quality management in a clinical laboratory setting. Responsibilities Duties/Tasks - Develops and recommends policy and… more
- Bayer (Washington, DC)
- …to make a real difference, there's only one choice.** **Director US Medical Affairs Women's Healthcare** The Director US Medical Affairs Women's Healthcare will ... and participate in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an… more
- Johns Hopkins University (Baltimore, MD)
- …JHU equivalency formula. **Preferred Qualifications** + PhD + Extensive experience with clinical research sciences, regulatory affairs . + Extensive ... _Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the Program._… more
- Johns Hopkins University (Lutherville, MD)
- …Medicare and Medicaid Services, and Environmental of Care. + Work with the JHH Regulatory Affairs Office, JHHS Compliance Office, JHU CPA, and Office of Billing ... The Department of Otolaryngology is seeking a **_CO_** **_Clinical Nurse Manager_** the Clinical Nurse Manager collaborates with the Medical Director and Clinic… 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
- TestPros (Silver Spring, MD)
- …and regulatory requirements. + Collaborate with cross-functional teams, including Regulatory Affairs , Product Development, and Project Management, to ensure ... Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to...compliance issues. Qualifications: + Bachelor's degree in Quality Assurance, Regulatory Affairs , Life Sciences, or a related… more
- Sumitomo Pharma (Washington, DC)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Washington, DC)
- …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 (Washington, DC)
- …+ 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
- 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