ProSidian Consulting, LLC
Senior Reg Ops Specialist SME | Healthcare and Life Sciences [HHS122027]
ProSidian Consulting, LLC, Washington, District of Columbia, us, 20022
Senior Reg Ops Specialist 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. We help forward thinking clients solve problems and improve operations. Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes. ProSidian Seeks a Senior Reg Ops Specialist SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Executive Consultant/SME II Mid Level Professional aligned under services related to NAICS: 541611. Seeking Senior Reg Ops Specialist SME candidates with relevant Healthcare And Life Sciences Sector Experience to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. JOB OVERVIEW
Provide services and support as a Healthcare And Life Sciences (Senior Reg Ops Specialist 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) to include white papers/market research abstracts, technical proposals, and budget proposals. 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. Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission. DESIRED QUALIFICATIONS
At least 15 years of progressive experience in regulatory operational activities supporting FDA-regulated product development. Deep expertise in FDA submission types, eCTD specifications, and advanced regulatory operations. Strong leadership in submission management. EDUCATION / EXPERIENCE REQUIREMENTS / QUALIFICATIONS
Bachelor’s degree or equivalent qualification in a relevant field. Additional certifications or training in regulatory operations and publishing software preferred. SKILLS REQUIRED
Superior competency in MS Word, Adobe Acrobat, and PDF toolsets. Experience with electronic publishing software and XML document creation. Advanced knowledge of FDA and ICH submission requirements. Ability to self-train in specialized areas. Strong project management skills for submission coordination and timeline management. BENEFITS AND HIGHLIGHTS
ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. We invest in our employees to help them stay healthy and achieve work-life balance. Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans. 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor’s appointment, or any number of events in your life. 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.
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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. We help forward thinking clients solve problems and improve operations. Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes. ProSidian Seeks a Senior Reg Ops Specialist SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Executive Consultant/SME II Mid Level Professional aligned under services related to NAICS: 541611. Seeking Senior Reg Ops Specialist SME candidates with relevant Healthcare And Life Sciences Sector Experience to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. JOB OVERVIEW
Provide services and support as a Healthcare And Life Sciences (Senior Reg Ops Specialist 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) to include white papers/market research abstracts, technical proposals, and budget proposals. 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. Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission. DESIRED QUALIFICATIONS
At least 15 years of progressive experience in regulatory operational activities supporting FDA-regulated product development. Deep expertise in FDA submission types, eCTD specifications, and advanced regulatory operations. Strong leadership in submission management. EDUCATION / EXPERIENCE REQUIREMENTS / QUALIFICATIONS
Bachelor’s degree or equivalent qualification in a relevant field. Additional certifications or training in regulatory operations and publishing software preferred. SKILLS REQUIRED
Superior competency in MS Word, Adobe Acrobat, and PDF toolsets. Experience with electronic publishing software and XML document creation. Advanced knowledge of FDA and ICH submission requirements. Ability to self-train in specialized areas. Strong project management skills for submission coordination and timeline management. BENEFITS AND HIGHLIGHTS
ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. We invest in our employees to help them stay healthy and achieve work-life balance. Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans. 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor’s appointment, or any number of events in your life. 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.
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