ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
IGP is recruiting for a Senior Product Manager to assist our government customer with supporting the US Army Medical Research and Development Command (USAMRDC) in Frederick, MD. The Senior Product Manager will support the U.S. Army Medical Materiel Development Activity’s (USAMMDA) Force Health Protection (FHP) Division in its mission to make available to DoD personnel Investigational New Drugs (INDs) under approved treatment protocols.
***Contingent upon contract award***
This support will include the following tasks:
- Provide scientific review and technical support to the FHPDivision products in support of the Director, Deputy Director, and Product Managers in the FHP
- Respond to technical and scientific related questions related to products in the FHPportfolio in the areas of infectious diseases, bio-threats or molecular diagnostics.
- Review the regulatory requirements for inventorying, archiving, storing, and transporting INDvaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices.
- Support the planning, development, and review of Expanded Access INDprotocols and their rollouts. Support FHP involvement in any Emergency Use Authorization (EUA) as needed.
- Develop and maintain expertise and training in Good Clinical Practice regulations.
- Demonstrate superior knowledge of and be able to provide top level technical reviews of Good Laboratory Practices (GLP) reports, annual reports, and similar data for products in the FHP Working knowledge of Current Good Manufacturing Practices (cGMP).
- Ensure compliance of the FHPportfolio of Expanded Access protocols with all applicable FDA, DoD, and local regulations and requirements.
- Review and analyze technical documents and make recommendations to ensure that sound scientific processes are used to support the Special Immunizations Program (SIP) portfolio of investigational vaccines. Ensure those processes and any deliverables meet all federal regulatory requirements for the use of investigational products.
- Maintain current knowledge of relevant technology and industry developments.
- Participate in special projects as required.
REQUIRED QUALIFICATIONS:
- Masters’ Degree in science discipline such as virology or microbiology
- 10 years’ related experience in scientific knowledge in areas of infectious diseases, bio-threats or molecular diagnostics.
- Experience as a scientific subject matter expert, responding to technical and scientific questions and provide support of the review of regulatory requirements for product compliance, inventory management, archiving, and storage of vaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices
- Proven understanding of FDArules and regulations regarding IND protocol submission, product compliance and management
- Working understanding of Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Current Good Manufacturing Practices (cGMP).
- US Citizenship required
- Ability to obtain a NACI public trust
PREFERRED QUALIFICATIONS:
- Doctoral Degree preferred
***Contingent upon contract award***
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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