ProSidian Consulting, LLC
Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014]
ProSidian Consulting, LLC, Washington, District of Columbia, us, 20022
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. Our 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 Reg Ops Specialist SME | Healthcare and Life Sciences on a full-time basis. The ideal candidate will have relevant Healthcare And Life Sciences Sector Experience and functional and technical area expertise 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 (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. DESIRED QUALIFICATIONS
At least 10 years of experience in leading regulatory operations supporting drug, biologic, and device development regulated by the FDA. Expertise in FDA submission types and eCTD specifications. Knowledge of ICH guidelines for CTD dossiers and electronic publishing. 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. BENEFITS AND HIGHLIGHTS
ProSidian offers a range of benefits, including competitive compensation, group health benefits, pre-tax employee benefits, and performance incentives. Our growing list of benefits currently includes: 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. 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. Our 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 Reg Ops Specialist SME | Healthcare and Life Sciences on a full-time basis. The ideal candidate will have relevant Healthcare And Life Sciences Sector Experience and functional and technical area expertise 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 (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. DESIRED QUALIFICATIONS
At least 10 years of experience in leading regulatory operations supporting drug, biologic, and device development regulated by the FDA. Expertise in FDA submission types and eCTD specifications. Knowledge of ICH guidelines for CTD dossiers and electronic publishing. 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. BENEFITS AND HIGHLIGHTS
ProSidian offers a range of benefits, including competitive compensation, group health benefits, pre-tax employee benefits, and performance incentives. Our growing list of benefits currently includes: 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. 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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