ProSidian Consulting, LLC
Vaccine and Biologic Development SME | Healthcare and Life Sciences [HHS128033]
ProSidian Consulting, LLC, Washington, District of Columbia, us, 20022
Vaccine and Biologic Development SME | Healthcare and Life Sciences
ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. ProSidian Seeks a Vaccine and Biologic Development SME | Healthcare and Life Sciences to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This is a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Vaccine and Biologic Development SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA). RESPONSIBILITIES AND DUTIES Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development; advanced clinical development; analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing. Serve as advisor(s) on Technical Evaluation Panels (TEPs). Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed. QUALIFICATIONS Subject Matter Expert (SME) in vaccine and biological drug development, particularly in regulatory studies and licensure programs. Expertise in the advanced development and acquisition of vaccines and biological drugs within BARDA’s mission. 10+ years of experience for Vaccine and Biological Drug Development SME. EDUCATION / EXPERIENCE REQUIREMENTS / QUALIFICATIONS Doctoral degree(s) in medicine or pharmacy (PhD, MD, PharmD, or equivalent). Extensive experience in regulatory studies, licensure programs, and advanced development in vaccines and biological drug. SKILLS REQUIRED Experience in the application of regulatory frameworks for vaccine and biological drug development. Knowledge of the FDA approval processes, regulatory submissions, and licensure programs. Expertise in the management and oversight of vaccine and biological drug development from preclinical through clinical phases. ProSidian Consulting is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
#J-18808-Ljbffr
ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. ProSidian Seeks a Vaccine and Biologic Development SME | Healthcare and Life Sciences to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This is a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Vaccine and Biologic Development SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA). RESPONSIBILITIES AND DUTIES Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development; advanced clinical development; analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing. Serve as advisor(s) on Technical Evaluation Panels (TEPs). Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed. QUALIFICATIONS Subject Matter Expert (SME) in vaccine and biological drug development, particularly in regulatory studies and licensure programs. Expertise in the advanced development and acquisition of vaccines and biological drugs within BARDA’s mission. 10+ years of experience for Vaccine and Biological Drug Development SME. EDUCATION / EXPERIENCE REQUIREMENTS / QUALIFICATIONS Doctoral degree(s) in medicine or pharmacy (PhD, MD, PharmD, or equivalent). Extensive experience in regulatory studies, licensure programs, and advanced development in vaccines and biological drug. SKILLS REQUIRED Experience in the application of regulatory frameworks for vaccine and biological drug development. Knowledge of the FDA approval processes, regulatory submissions, and licensure programs. Expertise in the management and oversight of vaccine and biological drug development from preclinical through clinical phases. ProSidian Consulting is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
#J-18808-Ljbffr