Product Management Support Blood SME - WPAC

Goldbelt Apex, LLC; Frederick (MD); On-site; USD 100,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off

Job summary

Goldbelt Apex is seeking a Product Management Support Blood SME - WPAC to serve as senior subject-matter expert in blood products, transfusion medicine, and related operations. You will advise product managers on advanced medical product development and participate in regulatory strategies and testing.

This role includes reviewing technical documentation, collaborating on IPTs, and traveling up to 30% to support DoD acquisition lifecycle and fielding activities.

Qualifications

• Subject-matter expertise in blood/blood products, transfusion medicine and related operations.
• Ability to provide independent senior-level technical analysis and recommendations.
• Experience with FDA-regulated medical products and regulatory considerations.

Responsibilities

• Serve as senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology and transfusion medicine.
• Advise product managers on advanced medical product development.
• Support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding and training.
• Review technical and regulatory documentation.
• Participate as senior SME on IPTs and communicate risks/recommendations to leadership.

Skills

Blood products

Transfusion medicine

Combat casualty care

Medical product development

Clinical studies

FDA-regulated products

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.

Goldbelt APEX is looking for a Product Management Support Blood SME - WPAC.

Responsibilities

Essential Job Functions

• Serve as senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology and transfusion medicine.
• Advise product managers on advanced medical product development.
• Support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding and training.
• Review technical and regulatory documentation.
• Participate as senior SME on IPTs and communicate risks/recommendations to leadership.

Qualifications

Necessary Skills and Knowledge

• Blood and blood products.
• Transfusion medicine/hematology.
• Combat casualty care and traumatic hemorrhage.
• Medical product research/development.
• Clinical/nonclinical studies.
• FDA-regulated medical products.

Minimum Qualifications

• Demonstrable subject-matter expertise in blood/blood products, blood research/operations, transfusion medicine and/or combat casualty care.
• Ability to provide independent senior-level technical analysis and recommendations.

Preferred Qualifications

• Current WPAC Blood SME incumbent.
• Military blood program experience.
• Combat casualty care product development.
• FDA biologics/drug/device experience.
• CMC experience.
• DoD acquisition lifecycle experience.
• Ability to travel up to 30%.

Pay and Benefits

The annual salary for this position is $100,000 to $165,000.

• At Goldbelt, we value and reward our team's dedication and hard work. We provide 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.