OTHER

FEED

UNKNOWN

TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system. The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.

Overview:
Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs.   Summary:The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.

Responsibilities:
Essential Job Functions:<ul><li>Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.</li><li>Serve as a subject matter expert in regulatory affairs at the working group-level to inform</li><li>innovative regulatory approaches to develop MCMs against emerging threats.</li><li>Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS</li><li>regulatory office on critical programmatic and project level regulatory challenges.</li><li>Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authorities</li><li>Provide input to Sponsors' regulatory documents for submission to FDA or other National</li><li>Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National </li><li>Regulatory Authority requirements and with the eCTD submission format, as applicable.</li><li>Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.</li><li>Contribute to the modification, development and implementation of internal policies and procedures.</li><li>Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.</li><li>Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies</li><li>Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.</li><li>Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.</li><li>Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.</li><li>Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious</li><li>Disease (EID), and other relevant emerging and re-emerging threat spaces.</li><li>Travel for presentations and seminars, and to observe and provide regulatory assessments of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).</li><li>The contractor shall receive debriefs at the Secret level on Biannual Threat Briefs and be able to assist on course of action development in support of IPT's.</li></ul>

Qualifications:
Necessary Skills and Knowledge:<ul><li>Strong communication skills, effectively communicating ideas, requirements, and scientific knowledge; and self-starter.</li></ul>Minimum Qualifications:<ul><li>Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. </li><li>Experience in developing and implementing regulatory strategies and overseeing regulatory filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).</li><li>Experience with providing critical review of documentation supporting regulatory applications.</li><li>Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines).</li><li>Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity.</li><li>Mastery of FDA and other relevant regulatory authorities' requirements for clinical study development and implementation and marketing and post-marketing. Contractors shall have experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.</li><li>Clearance: Secret</li></ul>Preferred Qualifications:<ul><li>Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired and will be at no cost to the Government.</li></ul> Pay and Benefits 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.

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.

Goldbelt, Inc.

Regulatory Affairs Manager V

Administrative Skills

Auditing

Biology

Clinical Trial

Communication Skills

Contract Review

Disease

Document Management

Documentation

Documentation Review

Drug Development

Due Diligence

Epidemiology

FDA (Food and Drug Administration)

FDA Requirements

Government

Government Funding

ICH Regulations

Internet/IP Telephony

Maintain Compliance

Manufacturing

Marketing

Medical Products

Negotiation Skills

Nursing

Pharmacodynamics

Pharmacokinetics

Pharmacy

Policy Implementation

Presentation/Verbal Skills

Product Development

Professional Services

Public Health

Quality Metrics

Regulations

Regulatory Compliance

Regulatory Submissions

Request for Proposals (RFP)

Requirements Management

Research Protocols

Scientific Research

Secret Clearance

Seminars

Software Administration

Strategic Analysis

Strategic Planning

Technical Support

Time Management

Vendor/Supplier Evaluation

Veterinary Medicine

White Papers

[AW]-iCims

The Brain Health Analyst assists with tracking research initiatives, identifying emerging scientific developments, and supporting development of strategic information products used by DoD leadership to assess progress in brain health and neurotrauma research. The Brain Health Analyst provides scientific and analytical support to the Blast Injury Research Coordination Office (BIRCO) within the Defense Health Agency (DHA) and U.S. Army Medical Research and Development Command (USAMRDC).

YEAR

Overview:
Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As healthcare IT experts, Apex is committed to building systems that enable healthcare organizations to communicate and exchange data seamlessly across disparate systems and devices.   Summary:The Brain Health Analyst provides scientific and analytical support to the Blast Injury Research Coordination Office (BIRCO) within the Defense Health Agency (DHA) and U.S. Army Medical Research and Development Command (USAMRDC). This position supports the Government in monitoring and analyzing Department of Defense (DoD) research activities related to brain health, neurotrauma, and cognitive injury associated with blast exposure. The Brain Health Analyst assists with tracking research initiatives, identifying emerging scientific developments, and supporting development of strategic information products used by DoD leadership to assess progress in brain health and neurotrauma research. The position contributes to coordination of research activities across DoD organizations, federal agencies, academia, and industry partners supporting blast-related brain health research.

Responsibilities:
Essential Job Functions:<ul><li>Provide analytical support to the Government in monitoring brain health and neurotrauma research activities related to blast injury across the DoD research enterprise.</li><li>Collect, analyze, and synthesize information on research programs, projects, and performers supporting brain health research related to blast exposure.</li><li>Conduct literature reviews and scientific analyses to identify emerging trends, knowledge gaps, and opportunities in brain injury and neurotrauma research.</li><li>Support development of executive-level information products including briefings, technical summaries, reports, and communication materials related to brain health research.</li><li>Assist with maintaining research tracking databases, knowledge repositories, and data collection systems used to monitor DoD brain health research activities.</li><li>Support tasking coordination by gathering research information, drafting responses, and assisting the Government in responding to requests for information related to brain health research initiatives.</li><li>Assist in development of strategic planning products including research roadmaps, gap analyses, white papers, and briefing materials related to blast-related brain health research.</li><li>Support planning and execution of BIRCO meetings, working groups, and research coordination events by preparing background materials, documenting discussions, and tracking action items.</li><li>Coordinate with DoD organizations, federal research agencies, academic institutions, and industry partners to gather information supporting brain health research coordination.</li><li>Assist in preparing scientific summaries and communication products that translate complex research findings into clear information for leadership and stakeholders.</li></ul>

Qualifications:
Necessary Skills and Knowledge:<ul><li>Knowledge of neuroscience, neurotrauma, brain injury research, or related biomedical research areas.</li><li>Strong analytical and scientific writing skills with the ability to translate research findings into executive-level communication products.</li><li>Experience reviewing and synthesizing biomedical research literature and research program information.</li><li>Ability to support coordination across multiple research organizations and stakeholders.</li><li>Strong organizational and data analysis skills supporting research tracking and reporting.</li></ul>Minimum Qualifications:<ul><li>PhD or Master’s degree in neuroscience, biomedical sciences, psychology, public health, physiology, or a related scientific discipline.</li><li>Experience supporting brain injury, neurotrauma, or blast-related research programs.</li><li>Minimum 5 years of experience supporting biomedical research analysis, research coordination, or scientific program support within DoD, federal agencies, academia, or industry.</li><li>Experience conducting literature reviews, preparing scientific analyses, or supporting research program tracking.</li><li>Clearance: Favorable adjudicated Tier 1 (NACLC); able to obtain a CAC.</li><li>Must be a U.S. Citizen.</li></ul>Preferred Qualifications:<ul><li>Familiarity with DoD medical research programs or defense health research initiatives.</li><li>Experience preparing executive-level briefings, reports, and scientific summaries.</li><li>Experience supporting research portfolio tracking or strategic research planning activities.</li></ul> Pay and BenefitsThe salary range for this position is $115,000.00 to $145,000.00 annually.  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.

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Regulatory Affairs Manager V Goldbelt, Inc.

Brain Health Analyst Goldbelt, Inc.

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