ProSidian Consulting, LLC
Senior Reg Ops Specialist SME | Healthcare and Life Sciences [HHS122027]
ProSidian Consulting, LLC, Washington, District of Columbia, us, 20022
Overview
Senior Reg Ops Specialist SME | Healthcare and Life Sciences (HHS122027). This is a full-time W-2 position supporting BARDA/ASPR within the Department of Health and Human Services (HHS). The role is located CONUS – Washington DC and the Mid Atlantic region and focuses on regulatory operations in the Healthcare and Life Sciences sector, including Medical Countermeasures development and regulatory documentation in support of BARDA missions.
Provide services and support as a Healthcare and Life Sciences Senior Reg Ops SME focusing on regulatory operations for clients such as HHS (BARDA/ASPR).
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 (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/licensure/clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Provide guidance and recommendations on key issues related to the area(s) identified above.
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.
Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
Develop work products (including 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, including solicitations, white papers, proposals, and post-award contract documents and deliverables).
Advise federal staff on the appropriateness and probability of success of Contractor proposed statements of work; make suggestions on ways to improve those statements of work.
Experience distilling complex information into informative and concise summaries, including risk/benefit analyses and balanced recommendations.
Participate in strategic discussions with USG to align new program areas with BARDA’s mission space.
Provide recommendations for project development level portfolio management and oversight as required.
Provide recommendations to develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; participate in market research efforts.
Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.
Provide subject matter expertise for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filing.
Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients.
Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews.
Qualifications
Desired Qualifications For Senior Reg Ops Specialist SME | Healthcare and Life Sciences (HHS122027):
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
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 (e.g., Lorenz or similar tools) and XML document creation.
Advanced knowledge of FDA and ICH submission requirements.
Ability to self-train in specialized areas (CSR publishing, PEUA, EUA).
Strong project management skills for submission coordination and timeline management.
Ability to design, review, and archive eCTD submissions, including original filings and amendments.
Knowledge of FDA regulatory frameworks, guidelines, and operational requirements.
Exceptional attention to detail in formatting, publishing, and dossier preparation.
Ancillary Details
Provide subject matter expertise for managing and submitting electronic dossiers to regulatory authorities and clients.
Liaise with regulatory affairs project managers and CROs to coordinate submission timelines and technical specifications.
Expertise in compliance with US publishing guidance and ICH specifications for electronic submissions.
Deliverables include properly formatted and compliant eCTD submissions, CSR publishing, and EUA filings.
Support BARDA Program Divisions by aligning with regulatory and operational requirements.
Provide training and guidance on publishing tools and FDA submission requirements.
Other Details
Work products shall be thorough, accurate, appropriately documented, and comply with established criteria. All employees shall conduct themselves to the highest standards of ethical and business conduct, ensuring duties are performed to meet milestones/delivery schedules.
Core Competencies
Teamwork –
ability to foster teamwork collaboratively as a participant, and effectively as a team leader
Leadership –
ability to guide and lead colleagues on projects and initiatives
Business Acumen –
understanding and insight into how organizations perform, including business processes, data, systems, and people
Communication –
ability to effectively communicate to stakeholders of all levels orally and in writing
Motivation –
persistent in pursuit of quality and optimal client and company solutions
Agility –
ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
Judgment –
exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
Organization –
ability to manage projects and activity, and prioritize tasks
Other Requirements
Business Tools –
understanding and proficiency with Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
Commitment -
to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
Curiosity –
the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
Humility –
exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
Willingness -
to constantly learn, share, and grow and to view the world as their classroom
Benefits and Highlights ProSidian Employee Benefits and Highlights:
Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That’s why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:
Competitive Compensation:
Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
Group Medical Health Insurance Benefits:
ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs. | Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.
Group Vision Health Insurance Benefits:
ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.
401(k) Retirement Savings Plan:
401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.
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. Currently these benefits include Vacation/Sick days – 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.
Pre-Tax Payment Programs:
Pre-Tax Payment Programs currently exist in the form of a Premium Only Plan (POP). These Plans offer a full Flexible Spending Account (FSA) Plan and a tax benefit for eligible employees.
Purchasing Discounts & Savings Plans:
We offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy on a daily basis.
Security Clearance:
Security Clearance requirements for Engagement Teams handling sensitive engagements in the Federal Marketplace; a Security Clearance is a valued asset in your professional portfolio.
Referral Bonus:
ProSidian pays up to $5k for referrals employed for 90 days for candidates submitted through our Referral Program.
Performance Incentives:
Performance incentives are associated with each new client that each employee works to pursue and support.
Flexible Spending Account:
FSAs help you pay for eligible out-of-pocket health care and dependent day care expenses on a pre-tax basis.
Supplemental Life/AD&D:
Optional supplemental life insurance; D&D covers death or dismemberment from an accident.
Short- and Long-Term Disability Insurance:
Disability insurance plans to provide income protection during recovery.
------------ ------------ ------------
Additional Information
- See Below Instructions On The Best Way To Apply
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 veteran status, or any other protected factor. All your information will be kept confidential according to EEO guidelines.
ProSidian Consulting has made a pledge to the Hiring Our Heroes Program of the U.S. Chamber of Commerce Foundation and the “I Hire Military” Initiative of The North Carolina Military Business Center (NCMBC) for the State of North Carolina. All applicants are encouraged to apply regardless of Veteran Status.
Furthermore, we believe in " HONOR ABOVE ALL " - be successful while doing things the right way. The pride comes out of the challenge; the reward is excellence in the work.
FOR EASY APPLICATION USE OUR CAREER SITE LOCATED ON http://www.ProSidian.com/ OR SEND YOUR RESUME’S, BIOS, AND SALARY EXPECTATION / RATES TO CAREERS @ PROSIDIAN.COM.
ONLY CANDIDATES WITH REQUIRED CRITERIA ARE CONSIDERED .
Be sure to place the job reference code in the subject line of your email. Be sure to include your name, address, telephone number, total compensation package, employment history, and educational credentials.
Risk Management | Compliance | Business Processes | IT Effectiveness | Engineering | Environmental | Sustainability | Human Capital
Job Location Mid Atlantic | CONUS - Washington DC
#J-18808-Ljbffr
Provide services and support as a Healthcare and Life Sciences Senior Reg Ops SME focusing on regulatory operations for clients such as HHS (BARDA/ASPR).
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 (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/licensure/clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Provide guidance and recommendations on key issues related to the area(s) identified above.
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.
Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
Develop work products (including 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, including solicitations, white papers, proposals, and post-award contract documents and deliverables).
Advise federal staff on the appropriateness and probability of success of Contractor proposed statements of work; make suggestions on ways to improve those statements of work.
Experience distilling complex information into informative and concise summaries, including risk/benefit analyses and balanced recommendations.
Participate in strategic discussions with USG to align new program areas with BARDA’s mission space.
Provide recommendations for project development level portfolio management and oversight as required.
Provide recommendations to develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; participate in market research efforts.
Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.
Provide subject matter expertise for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filing.
Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients.
Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews.
Qualifications
Desired Qualifications For Senior Reg Ops Specialist SME | Healthcare and Life Sciences (HHS122027):
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
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 (e.g., Lorenz or similar tools) and XML document creation.
Advanced knowledge of FDA and ICH submission requirements.
Ability to self-train in specialized areas (CSR publishing, PEUA, EUA).
Strong project management skills for submission coordination and timeline management.
Ability to design, review, and archive eCTD submissions, including original filings and amendments.
Knowledge of FDA regulatory frameworks, guidelines, and operational requirements.
Exceptional attention to detail in formatting, publishing, and dossier preparation.
Ancillary Details
Provide subject matter expertise for managing and submitting electronic dossiers to regulatory authorities and clients.
Liaise with regulatory affairs project managers and CROs to coordinate submission timelines and technical specifications.
Expertise in compliance with US publishing guidance and ICH specifications for electronic submissions.
Deliverables include properly formatted and compliant eCTD submissions, CSR publishing, and EUA filings.
Support BARDA Program Divisions by aligning with regulatory and operational requirements.
Provide training and guidance on publishing tools and FDA submission requirements.
Other Details
Work products shall be thorough, accurate, appropriately documented, and comply with established criteria. All employees shall conduct themselves to the highest standards of ethical and business conduct, ensuring duties are performed to meet milestones/delivery schedules.
Core Competencies
Teamwork –
ability to foster teamwork collaboratively as a participant, and effectively as a team leader
Leadership –
ability to guide and lead colleagues on projects and initiatives
Business Acumen –
understanding and insight into how organizations perform, including business processes, data, systems, and people
Communication –
ability to effectively communicate to stakeholders of all levels orally and in writing
Motivation –
persistent in pursuit of quality and optimal client and company solutions
Agility –
ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
Judgment –
exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
Organization –
ability to manage projects and activity, and prioritize tasks
Other Requirements
Business Tools –
understanding and proficiency with Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
Commitment -
to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
Curiosity –
the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
Humility –
exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
Willingness -
to constantly learn, share, and grow and to view the world as their classroom
Benefits and Highlights ProSidian Employee Benefits and Highlights:
Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That’s why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:
Competitive Compensation:
Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
Group Medical Health Insurance Benefits:
ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs. | Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.
Group Vision Health Insurance Benefits:
ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.
401(k) Retirement Savings Plan:
401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.
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. Currently these benefits include Vacation/Sick days – 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.
Pre-Tax Payment Programs:
Pre-Tax Payment Programs currently exist in the form of a Premium Only Plan (POP). These Plans offer a full Flexible Spending Account (FSA) Plan and a tax benefit for eligible employees.
Purchasing Discounts & Savings Plans:
We offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy on a daily basis.
Security Clearance:
Security Clearance requirements for Engagement Teams handling sensitive engagements in the Federal Marketplace; a Security Clearance is a valued asset in your professional portfolio.
Referral Bonus:
ProSidian pays up to $5k for referrals employed for 90 days for candidates submitted through our Referral Program.
Performance Incentives:
Performance incentives are associated with each new client that each employee works to pursue and support.
Flexible Spending Account:
FSAs help you pay for eligible out-of-pocket health care and dependent day care expenses on a pre-tax basis.
Supplemental Life/AD&D:
Optional supplemental life insurance; D&D covers death or dismemberment from an accident.
Short- and Long-Term Disability Insurance:
Disability insurance plans to provide income protection during recovery.
------------ ------------ ------------
Additional Information
- See Below Instructions On The Best Way To Apply
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 veteran status, or any other protected factor. All your information will be kept confidential according to EEO guidelines.
ProSidian Consulting has made a pledge to the Hiring Our Heroes Program of the U.S. Chamber of Commerce Foundation and the “I Hire Military” Initiative of The North Carolina Military Business Center (NCMBC) for the State of North Carolina. All applicants are encouraged to apply regardless of Veteran Status.
Furthermore, we believe in " HONOR ABOVE ALL " - be successful while doing things the right way. The pride comes out of the challenge; the reward is excellence in the work.
FOR EASY APPLICATION USE OUR CAREER SITE LOCATED ON http://www.ProSidian.com/ OR SEND YOUR RESUME’S, BIOS, AND SALARY EXPECTATION / RATES TO CAREERS @ PROSIDIAN.COM.
ONLY CANDIDATES WITH REQUIRED CRITERIA ARE CONSIDERED .
Be sure to place the job reference code in the subject line of your email. Be sure to include your name, address, telephone number, total compensation package, employment history, and educational credentials.
Risk Management | Compliance | Business Processes | IT Effectiveness | Engineering | Environmental | Sustainability | Human Capital
Job Location Mid Atlantic | CONUS - Washington DC
#J-18808-Ljbffr