Job Description
Overview:
Please note that this position is contingent upon the successful award of a contract currently under bid.
Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.
Summary:
Goldbelt APEX is looking for a Medical Advisor Support – WRPBH.
Responsibilities:Essential Job Functions:
- Provide medical/scientific SME support for medical devices, diagnostics, drugs, biologics, blood products, medical countermeasures, PTSD/TBI, or related medical solutions.
- Provide clinical management expertise for clinical research and clinical trials.
- Review protocols, IND/IDE packages, CMC documentation, safety data, and regulatory submissions.
- Support FDA, EPA, DoD, DHA and JTS coordination.
- Participate as a substantive IPT SME.
Necessary Skills and Knowledge:
- Clinical research and medical product development.
- FDA-regulated products.
- Clinical trial design/oversight.
- Regulatory strategy.
- Ability to review complex medical/scientific data and provide senior-level recommendations.
Minimum Qualifications:
- Medical degree, doctorate, other advanced degree, OR certification in a medical, scientific, or technical field related to the applicable medical product development area.
- Ability to apply DoD acquisition knowledge with relevant clinical/scientific expertise.
- Travel: Up to 20%
Preferred Qualifications:
- Current WRPBH/DHA medical advisor incumbent.
- PTSD/TBI, neuroscience, neurology, psychiatry, or Warfighter performance experience.
- Clinical trial experience.
- FDA/IND/IDE experience.
- CMC/GMP knowledge.
- Military medicine experience.
Pay and Benefits
The annual salary for this position is $100,000 to $160,000.
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
Numbers & Facts
| Location | Fort Detrick, Maryland |
| Job Type | Full-time |
| Industry | Other/Not Classified |
| Salary | $100,000–$160,000 Per Year |
| Company Size | 500 to 999 employees |
| Year Founded | 1974 |
| Website | http://goldbelt.com |
About Company
Goldbelt, Incorporated is an urban Alaska Native, for‐profit corporation headquartered in Juneau, Alaska. Incorporated on January 4, 1974 following the Alaska Native Claims Settlement Act (ANCSA), Goldbelt’s primary mission is to manage assets and conduct business for the benefit of its more than 3,600 shareholders. Goldbelt first ventured into the logging and timber industry but later expanded its operations into tourism, which still remains an integral part of its operations. Today, the majority of Goldbelt’s revenue and income derives from government contracting and services.
Goldbelt’s shareholder base consists of Alaska Natives who are of Tlingit and Haida descent. The Tlingit and Haida tribes are the indigenous people of Southeast Alaska, whose rich history spans more than ten thousand years in the region. Goldbelt shareholders own the entire 272,000 shares of Goldbelt stock, representing assets in excess of $100 million in addition to over 32,000 acres of land in the vicinity of Juneau. Goldbelt seeks to honor and preserve the Tlingit culture - its history, art, dance, legends, and the traditions of its Alaska Native shareholders. Learn more about Goldbelt Heritage.
The company is named after a richly mineralized zone in Southeast Alaska that encompasses 33,000 acres of Goldbelt’s land holdings— an area that stretches along the mainland from Frederick Sound to Berners Bay. Learn more about Goldbelt Lands.
Skills
- Building Systemsunmatched
- Clinical Researchunmatched
- Clinical Trialunmatched
- DoD Acquisitionsunmatched
- Documentationunmatched
- Environmental Protection Agency (EPA)unmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Health Information Technologyunmatched
- Healthcareunmatched
- Hospital/Healthcare Constructionunmatched
- IDE (Integrated Development Environment)unmatched
- Internet/IP Telephonyunmatched
- JTS (Java Transaction Services)unmatched
- Medical Diagnosisunmatched
- Medical Equipmentunmatched
- Medical Office Administrationunmatched
- Medical Productsunmatched
- Medicineunmatched
- Militaryunmatched
- Neurologyunmatched
- Neuroscienceunmatched
- Post Traumatic Stress Disorder (PTSD)unmatched
- Product Developmentunmatched
- Psychiatry and Mental Healthunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- United States Department of Defense (DoD)unmatched
- Willing to Travelunmatched
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