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Senior Regulatory CMC Project lead

posted by: spj_bot

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

Main Responsibilities:

Job Skills

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AI Engineer - Generative AI and Agents

posted by: spj_bot

Azumo builds and operates production AI systems for companies ranging from seed-stage startups to Meta. We are hiring an AI Engineer to own what those systems do once they are live: retrieval pipelines, tool-using agents, evaluation harnesses, and the guardrails that keep them dependable in front of real users. The role is fully remote across Latin America, aligned to your client's working day.

You will not be building demos. Azumo has shipped production AI since 2016, and the work here starts where the prototype ends, making a system reliable, measurable, and affordable enough to put in front of customers.

Where this role sits

Azumo's engineering organization is built around four lanes. The Data Engineer lane owns pipelines, storage, and the retrieval layer. The Data Scientist lane owns the question and the method. The Software Engineer lane owns AI-augmented product delivery. This role is the AI Engineer lane, and it owns production behavior.

One question places the boundary: when the output is wrong, whose problem is it? "The method was inappropriate" is a Data Scientist question. "The system did the wrong thing with an appropriate method" is yours.

What you will build

Job Skills

demonstrable production professional grading terraform operates prototype reliability embedding validation operation containerized high throughput data engineer file github com code review hipaa test design window management computer science write backend self host San api design latin hosted tooling remuneration toolchain libraries career development open source teaching python testing code sanitization throughput reliable storage workflows philanthropy programming docker automated audit based systems data science infrastructure as code stage fallbacks software development layer budgets real time technical writing embedded tracking infrastructure human in the loop english support engineers e codebase generation function enforcement chunking software engineer error analysis production software
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Evaluation Specialist, Jr.

posted by: spj_bot

Gritter Francona is looking for an Evaluation Specialist, Jr. that will provide evaluation, performance measurement, data analysis, and reporting support for the design, implementation, evaluation, and scaling of an Elevated Risk Care Management (ERCM) Pilot focused on improving the coordination and effectiveness of suicide prevention-related care for Veterans at elevated risk.

The Evaluation Specialist, Jr. will support the development and implementation of evaluation systems that measure program activities, implementation progress, outcomes, and overall impact. Working closely with Government program leads, evaluation staff, clinical stakeholders, and the contractor team, this position will collect, organize, analyze, and communicate quantitative and qualitative information to support evidence-based decision-making.

The Evaluation Specialist, Jr. will contribute throughout the pilot lifecycle, including Concept, Explore, Design, Implement, Evaluate, and Spread phases. The position will support the integration of evaluation activities into program operations, assist with performance reporting, identify trends and lessons learned, and help translate evaluation findings into actionable recommendations for program refinement and potential national expansion.

Job Skills

secondary research evaluation staff data collection evaluation informed leadership evidence based inform evaluation health administration risk management decision make ira ul process improvement research integration program managers social sciences performance measurement performance indicators milestones performance monitor focus group visualizations health research performance reporting dashboards health care data quality continuous improvement translate operational analytical coordination key performance indicator subject matter targeted public health analytics behavioral data analysis content analysis quality improvement behavioral health presentations performance monitoring collaborate life insurance long term care coordination healthcare analytic communicate performance report operations collection stakeholder engagement surveys translating qualitative analysis instruments statistics technical writing toolkits program evaluation care plan disability refinement tracking retirement plan scale government plans coordinate support development planning structured interview performance measures track
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Elevated Risk Care Management - Project Manager

posted by: spj_bot

Gritter Francona is looking for a Project Manager that will provide comprehensive project management and implementation support for the design, launch, management, evaluation, and preparation for scaling an Elevated Risk Care Management (ERCM) Pilot focused on improving the coordination, effectiveness, and continuity of suicide prevention-related care for Veterans at elevated risk.

The Project Manager will serve as the single contractor point of contact for the Veterans Health Administration (VHA) for requests for subject matter expert (SME) support and matters related to contractor performance. The Project Manager will work closely with Government program leads, designated stakeholders, clinical teams, and contractor personnel to coordinate and execute approved activities throughout the pilot lifecycle, including Concept, Explore, Design, Implement, Evaluate, and Spread phases.

The position requires strong project management, stakeholder coordination, healthcare implementation, clinical workflow, documentation, and communication skills. The Project Manager will ensure that project activities remain organized, on schedule, appropriately documented, and aligned with Government objectives and requirements.

Job Skills

professional business administration evidence based project management communication structures project governance dashboards timelines subject matter public health integrated system project coordination finalization training stakeholder project resource professional project communication skills operations standard operating procedure reach disability toolkits care plan coordinate support development project plans manage project documentation decision make project evaluation services public mitigation plan operational coordination behavioral health administration health project performance project implementation project governance selected sites government integrated project track leadership project risks risk management ul integration phase life insurance corrective actions performance monitoring project schedule workflows collaboration program management technical documentation stakeholder engagement integrated team tracking retirement plan integrated operating planning ira performance measures health administration mental health deliberate communicate project life basic milestones management schedules project manager working groups health care continuous improvement translate long term templates care coordination schedule resource constraint technical writing corrective action site selection scale workflow plans onboarding collection execute
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Elevated Risk Care Management - Program Manager

posted by: spj_bot

Gritter Francona is looking for a Program Manager to provide comprehensive program and project management support for the design, launch, management, evaluation, and preparation for scaling an Elevated Risk Care Management (ERCM) Pilot focused on improving the coordination, effectiveness, and continuity of suicide prevention-related care for Veterans at elevated risk.

The Program Manager will serve as a key contractor resource supporting Government program leads and designated stakeholders throughout the full pilot lifecycle, including Concept, Explore, Design, Implement, Evaluate, and Spread phases. The position requires strong healthcare program management expertise, clinical workflow understanding, implementation experience, stakeholder coordination skills, and the ability to translate complex program requirements into actionable plans, deliverables, and operational tools.

Job Skills

professional business administration evidence based project management communication practical clinical transition planning primary care dashboards governance timelines public health integrated system finalization standard operating procedure coordinating reach disability toolkits care plan refinement coordinate support development manage decision making project documentation care management decision make cross functional mitigation plan performance measurement communications operational coordination behavioral health communicate level communications project governance selected sites integrated plans government integrated project track leadership risk management leadership clinical ul social clinical phase tests approaches program manager life insurance corrective actions performance monitoring workflows collaboration federal system program management stakeholder engagement integrated team retirement plan integrated operating planning ira performance measures administration public meeting minutes version control social sciences mental health deliberate life basic milestones management schedules health care translate long term care coordination technical writing site selection scale workflow plans onboarding collection execute
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Systems Engineer III - C

posted by: spj_bot

**Position is contingent upon contract award.

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

The Acquisition Systems Engineer provides comprehensive systems engineering and technical acquisition support to Marine Corps Systems Command acquisition programs throughout the systems engineering lifecycle. The position supports the planning, execution, documentation, and management of Systems Engineering Technical Reviews (SETRs), Test and Evaluation (T&E) activities, requirements management, risk management, and technical documentation development.

Job Skills

sharepoint requirements traceability business administration data package programs < small business technical support services results lifecycle collaboration tool support government technical reviews timelines work environment STD related technical discipline system requirement test test system performance system specification documentation development read specifications work product teams test datum engineering support facilities test results remain < li><li reduction engineering analysis microsoft office decision make cross functional > provide specification documentation system engineering data and development preparation documentation supporting problem solve level integrated microsoft project work breakdown structure systems and experience supporting systems engineer draft system verification projection calendars < p><ul><li strong technical requirement traceability field service li > reporting activities li><li engineering technical secret clearance development review requirement specification quality assurance occupational health electrical engineering resolution integrated master > experience acquisition process government technical review integrate product team track certified service verification tests traceability matrix risk management disabled systems li><li > qualifications skills logistics ability to engineering management interface requirements incident report life insurance corrective actions management tools engineering guidance collaboration > < groups < engineering system program management setrs test technical documentation > minimum planning execution scrum supports government support engineering test strategy tracking aerospace engineering technical support mechanical engineering products data data management systems engineering nbsp management integrated product technical analysis skills < test reports management process operational testing requirement management computer engineering templates > ability test execution consulting technical writing change management master plans technical management
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Program Analyst - C

posted by: spj_bot

**Position is based on contract award

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

The Acquisition Program Analyst provides comprehensive acquisition and programmatic support services to Department of Defense (DoD) and Marine Corps acquisition programs. The position supports Acquisition Category (ACAT) programs, Abbreviated Acquisition Programs (AAPs), Middle Tier Acquisition efforts, and Other Transaction Authority (OTA) initiatives throughout the acquisition lifecycle in accordance with applicable Federal Acquisition Regulation (FAR), Defense Federal Acquisition Regulation Supplement (DFARS), DoD 5000 series guidance, and Marine Corps Systems Command acquisition policies.

Job Skills

business administration project management adms reviews setrs coordination < small business scheduling acquisition technical support services topic 7 technical reviews work environment STD IMP groups rwgs read product teams reviews otrrs < li><li < li reviews and 7 0 microsoft office mitigation administrative support organizational skill < reporting tool acquisition management communications system engineering federal acquisition regulation supplement m verbal communication microsoft project program analysis draft < p><ul><li field service secret clearance development review quality assurance integrated master sharepoint microsoft government employer integrate product team track certified service leadership risk management management logistics disabled program managers integration microsoft team li><li > depending on qualifications skills logistics editing life insurance technical solutions workflows suite sharepoint program management scrum tracking development integrated integrate master plan review boards accounting development and meeting minutes data management master scheduling risk management tool technical editing management naval messages handle system related discipline scheduling analytical management process presentations templates procurement federal regulation schedule consulting technical writing development implementation
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Configuration Manager II - C

posted by: spj_bot

**Position contingent upon contract award

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

The Configuration Manager provides comprehensive configuration management and technical documentation support to Marine Corps Systems Command acquisition programs. The position supports the management and control of system baselines, engineering documentation, hardware and software configuration items, engineering changes, and technical data throughout the acquisition lifecycle in accordance with Department of Defense (DoD), Department of the Navy (DoN), and MCSC configuration management policies and procedures.

Job Skills

professional traceability business administration accounting system tracking systems small business support services communication edit work environment STD control processes standard operating procedure security management read product teams secure data e coordinate support development manage system configuration microsoft office textile technology controlled plan system engineering operational control coordination problem solve libraries lifecycle processes firmware draft archives storage field service engineering documentation process engineering engineering change secret clearance requirement specification validate systems processes government configuration audit track configuration item configuration management disabled lifecycle management qualifications skills logistics life insurance corrective actions security requirements program management technical documentation textile engineering management technical configuration manager tracking physical configuration revisions integrated review boards textiles planning accounting engineering changes validation engineering facilities data management design review management generate reports analytical certification analysis management process configuration audits controlled documents audit consulting technical writing change management plans documentation technical audits
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Senior ML Engineer

posted by: spj_bot

Location: New York, United States (Office) - Must be able to work office based in NYC

On-Site | Full-time

Compensation: $300K - $375K

Our client, a premier venture accelerator backing high-growth technology and emerging-tech startups, is seeking an experienced and self-directed Senior Machine Learning Engineer to join their in-house engineering team in New York City.

Reporting directly to the Chief Technology Officer (CTO), the Senior Machine Learning Engineer will take full ownership of features throughout the product lifecycle—from requirements definition to production deployment. This onsite role requires an entrepreneurial mindset and deep technical execution to turn loosely defined problems into robust, production-ready machine learning and LLM-based systems without reliance on large engineering teams or dedicated project managers.

Key Responsibilities

Job Skills

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Technical Writer/Editor

posted by: spj_bot

Gritter Francona is looking for a Technical Writer/Editor that will be responsible for researching, writing, editing, and reviewing a broad range of written materials supporting the Veterans Health Administration (VHA) National Center for PTSD's educational media initiatives. The Technical Writer/Editor develops clear, accurate, and accessible content that translates scientific evidence, clinical protocols, and technical information into plain language materials for Veterans, trauma survivors, caregivers, healthcare providers, and the general public.

Working collaboratively with project managers, subject matter experts (SMEs), scriptwriters, video producers, graphic designers, and Government stakeholders, the Technical Writer/Editor ensures all written products are evidence-based, technically accurate, grammatically sound, and consistent with the National Center for PTSD's mission of providing compassionate, trauma-informed, and culturally sensitive educational resources. Written materials must maintain a serious yet hopeful tone that encourages treatment engagement while communicating complex behavioral health concepts in an understandable and engaging manner.

Job Skills

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