- Serve as a SME in the area of Blood and Blood Products, Blood Research, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, brain injury, hematology, and transfusion medicine.
- Provide top level technical expert support to WPAC and work closely with the advanced development team to support the DoD acquisition requirements for medical product development.
- Act as integral member of Integrated Product Teams (IPT) in support of medical product development and acquisition in the combat casualty care product portfolio.
- Actively involved in the review process of clinical protocols and associated clinical trial documents, various regulatory applications, DoD acquisition documentation and Food and Drug Administration (FDA) documentation.
- Perform highly specialized technical tasks including design and evaluation of non-clinical studies, clinical trial designs, review of non-clinical study reports, and technical inputs into the chemistry, manufacturing and controls of biologics, drugs and devices.
- Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
- Support numerous efforts and effectively prioritize and multi-task requirements.
- Maintain current knowledge of relevant technology and industry developments.
- Participate in various meetings both internally and externally to the organization.
- Attend and participate in periodic site visits, off-site meetings and briefings, sub-working group meetings and investigator meetings.
- Participates in special projects as required.
- Masters' Degree in related scientific discipline; Ph.D. preferred.
- 6+ years of related experience.
- Experience in medical product development.
- Experience with various stages of FDA-regulated product development.
- US Citizen.
- Ability to obtain T1 (Public Trust) - NACI Clearance.
- Must be able to pass background and drug testing.
- Position may be flexible (remote work, hours, part-time/full-time) for the right person.
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Technical Subject Matter Expert - Frederick, United States - KurzSolutions
Description
The City of Clustered SpiresThe Community - Frederick, Maryland
Frederick, Maryland has a little bit of everything for everybody. With a rich, detailed history in the Civil War there are museums aplenty that will entertain and impress those of all ages, or if a bit of treasure hunting is more what you're interested in then look no further than Frederick; well, maybe look a little deeper, within Frederick. Their stores have an incredible variety of old and new, chic to antique in any which way you'd like to go. In addition to those incredible bouts of adventure within itself, be sure to enjoy the rich variety of performing and visual arts. Then again, if you're looking for actual adventure to get your blood pumping, you'll have to check out the vast opportunities for hiking, biking, camping, golfing and fishing in any of their stunning parks.
Explore Frederick here.
About the Facility - Fort Detrick
The Clinical Research Associate/Clinical Trial Monitor will be located at Fort Detrick in Frederick, Maryland in support of a contract with the Office of Regulated Activities (ORA) under the U.S. Army Medical Research and Development Command (USAMRDC). ORA is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing medical products for the Warfighter. ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.
Facility Address: 810 Schreider St, Fort Detrick, Frederick, MD 21702
RESPONSIBILITIES (listed are included but not limited to)
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