Goldbelt, Inc.

Biofab Product Management Support Specialist

Job Locations US-MD-Fort Detrick
ID
2023-11952
Category
Healthcare
Position Type
Regular Full-Time

Overview

Goldbelt Frontier fosters a collaborative environment where employees are encouraged to utilize and employ their operational and leadership skills. Many senior project managers and business analysts are subject matter experts in their respective fields. Frontier understands how to support multiple stakeholders to aid in developing and implementing national policies, strategies, and doctrine.

 

SUMMARY

 

The Product Management Support Specialist will provide support to the USAMMDA within the realm of the DoD’s acquisition process.  This position shall apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for product development. The position shall support the organization in the day-to-day medical product development activities according to U.S. Army, USAMRDC, USAMMDA, and DoD acquisition policies and regulations. Shall participate in Integrated Product Team (IPT), Working Group, Product Lifecycle Review Committee (PLRC), and Investigator meetings; as well as other meetings that are part of the acquisition process including, but not limited to, In Process Reviews and Milestone Reviews.

Responsibilities

ESSENTIAL JOB FUNCTIONS 

  • Organize and prepare for meetings, schedule teleconferences, create and distribute agendas, create meeting minutes to include draft/final minutes, and deliver assessments in the form of information products including packages and briefings to the organization. 
  • Coordinate and conduct site visits (e.g., clinical, vendors, testing facilities, manufacturing facilities). 
  • Coordinate the conduct of developmental testing as well as support and coordinate operational assessment and testing, to include delivery of test items such as test articles and manuals.   
  • Prepare and maintain project management integrated master schedules, Gantt charts, and action item lists for assigned programs, based on input from the organization, outside consultants, and key USAMRDC staff according to project management best practices and DoD guidelines to monitor program progress.   
  • Edit and maintain technical, budget, programmatic, administrative, and acquisition milestone documentation, to include program briefings IAW applicable DoD 5000 series regulations to ensure successful decision reviews, such as Business Case Analysis (BCA), Strategy Plans, Integrated Program Summary, Life Cycle Cost Estimates (LCCEs), Test and Evaluation Master Plans (TEMPs), and operating and maintenance instructions. 
  • Shall communicate and coordinate with internal and external stakeholders to meet program objectives and shall document their coordination; including the achievement of concurrence and/or non-concurrence with comment as directed by USAMMDA.
  • Shall populate and maintain tracking of action items/taskers for specified product development programs according to DoD, Army, USAMRDC, and USAMMDA policies and procedures. 
  • Monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate.
  • Support management of the progress of projects/products and provide recommendations on acquisition strategies, maturity, and risk of technologies, assess capability gaps for the focus areas for further development and/or investment.
  • Manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems. 
  • Provide support for all testing as well as all FDA and non-FDA regulated events. 
  • Monitor the progress of clinical projects and provide recommendations on impact to acquisition strategies, maturity and risk of technologies, ability to address capability gaps for the focus areas for further development and/or investment.  
  • Support the clinical projects to ensure the Grants Officer Representative and/or COR has auditable clinical tracking and status reports and meets acquisition regulatory requirements.
  • Conduct market research, support analyses, review existing tech base programs, and recommend acquisition strategies to strengthen and engage medical requirements and/or medical capabilities in support of force health protection and provide information packages based on the results of these analyses. 
  • Participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment. 
  • Support the management and execution of product evaluations and responses for the New Products and Ideas submissions. 
  • Perform other duties as assigned.

Qualifications

NECESSARY SKILLS AND KNOWLEDGE

  • Ability to apply interpersonal skills and knowledge of the DoD 5000 to products being supported.   
  • Have the capability to utilize Microsoft (MS) Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word, at an intermediate level. 
  • Have the capability of developing and updating schedules, as well as assist in the development of LCCEs. 
  • Capability of integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process.
  • Excellent communication skills, both verbal and written.

 

MINIMUM QUALIFICATIONS (education, experience, skills)

  • Bachelor's Degree in related field.
  • At least 16 years of related experience.
  • Ability to successfully pass a background check.
  • Experience, knowledge, and ability to execute using Microsoft Office Suite, Word, PowerPoint, and Excel, as well as Microsoft Outlook 

 

PREFERRED QUALIFICATIONS (education, experience, skills)

  • Master's Degree in related field.
  • Seven (7) years of experience with medical product development, DoD T&E requirements, and regulatory approval processes is preferred.
  • PMP certification or other project management training is a plus
  • Capability to apply DoD acquisition integration to specific developmental technologies including, vaccine technology and drug treatment therapies for infectious diseases of military relevance; and/or regenerative medicine; and/or blood and blood products and other combat casualty care products or devices; and/or post-traumatic stress disorder and traumatic brain injury; and/or medical support system and evacuation products and/or systems; and/or clinical and regulatory support.

Compensation for this position is:  $120,000.00-$125,000.00 Annually.

 

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.

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