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Leader Regulatory Affairs CMC (drug substance)

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 CMC Regulatory Consultant specializing in drug substance 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 Regulatory CMC Department is looking for a senior consultant with drug substance development experience, he/she will mainly be responsible for leading the regulatory strategy.

Main Responsibilities:

Job Skills

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Security Analyst II

posted by: spj_bot

Location: National Capital Region (Pentagon, Mark Center, Crystal City, and other Government facilities)
Clearance Required: Active Top Secret/SCI Clearance
Travel: Local NCR travel may be required

 

**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 War 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!

We are seeking a highly motivated Security Analyst II to support the Washington Headquarters Services (WHS) Security Enterprise Services Directorate (SESD). The successful candidate will provide professional security support services, policy analysis, administrative security management, inspections, compliance oversight, and customer support to Department of War organizations and senior leadership. This role requires strong analytical skills, attention to detail, and the ability to manage multiple security programs simultaneously in a fast-paced environment.

Job Skills

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Local Clinical Project Manager

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Trial Manager (CTM), you will serve as the central point of contact for clinical studies in France, ensuring the successful planning, execution, and close‑out of clinical trials. You will work closely with internal stakeholders, investigational sites, CROs, and regulatory authorities to deliver studies on time, within budget, and in compliance with applicable regulations and quality standards.

Key Responsibilities

Job Skills

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Assurance Quality Management Support

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a QMS Support Manager, you will support a strategic site transformation project by ensuring the successful integration of quality management systems and documentation processes following the transfer of activities to the Gidy site. You will play a key role in document harmonization, training, quality oversight, and change management while ensuring compliance with GMP requirements and project timelines.

Key responsibilities :

  • Quality management of new business requirements
  • Implementation of defined processes and support to requestors
  • Supplier monitoring and follow-up
  • Management of quality events related to supplier management: Change Controls, deviations related to the process, including compliance with timelines, supplier notifications, supplier complaints
  • Management of process-related documentation
  • Participation in continuous process improvement initiatives
  • Contribution to QMS (Quality Management System) department activities
  • Participation in inspections and audits, including the management of action plans
  • Support to business functions in monitoring and adhering to the process

Requirements

Job Skills

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Analyst / Senior Analyst - Data Governance & Lineage

posted by: spj_bot

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning, and AI. Our business value and leadership have been recognized by various market research firms, including Forrester and Gartner.

We are looking for an Analyst / Senior Analyst to support a large-scale enterprise data governance program with one of our leading clients.

Responsibilities:

  • Document data lineage from Tier 1 consumption points through analytical data stores to systems of origin, capturing findings in the client's preferred tooling.
  • Support the design, development, and deployment of ADS components, data pipelines, and data quality controls (DQ rules, variance analysis, anomaly detection, comprehensiveness checks) on GCP.
  • Contribute to data modeling and target-state landscape design, support SME interviews, and work closely with engineering teams and business data office stakeholders day-to-day.
  • Operate as the bridge between engineering, enterprise architecture, and data office stakeholders, and present findings and recommendations directly to senior client leadership.
  • Bridge business and technical requirements by translating insights from the business data office into actionable engineering tasks.

Requirements

Job Skills

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Pharmacokineticist Expert

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As an Operational PK/PD Expert, you will provide operational support to the Global Early Phases Clinical Expert and contribute to the development, registration, and commercialization of products across the portfolio.

Responsibilities include:

Job Skills

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Pharmacovigilance Officer

posted by: spj_bot

Rejoignez Excelya, où l’audace, l’attention portée aux autres et l’énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse. Vous jouerez un rôle clé dans le domaine qualité en pharmacovigilance, vous garantissez la conformité des processus et contribuez activement à l’amélioration continue, en lien étroit avec les parties prenantes internes et externes.

Vos missions principales :

  • Assurer la gestion qualité des déviations PV (RCA, CAPA, conformité des processus et délais).
  • Identifier les risques qualité et mettre en œuvre des actions correctives adaptées.
  • Contribuer à la documentation qualité PV et au plan qualité annuel.
  • Soutenir le système qualité (QMS) via le suivi des CAPA, KPI, déviations et changements.
  • Participer aux audits/inspections et garantir la conformité des partenaires et fournisseurs.

Requirements

Job Skills

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Senior Digital Marketing Consultant

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Main Responsibilities:

  • Assess consumer engagement, digital marketing, omnichannel, content, data, and measurement maturity to identify capability gaps and opportunities.
  • Define a consumer engagement strategy by prioritizing target audiences, journeys, and high-impact activation opportunities.
  • Integrate SEO, GEO, and AI/LLM discoverability into content, channel, and activation strategies.
  • Design consumer journey blueprints and translate them into actionable roadmaps and campaigns.
  • Lead the implementation roadmap, including governance, milestones, KPIs, dependencies, and decision-making processes.
  • Develop and launch a consumer strategy pilot, measuring performance and driving optimization.
  • Collaborate cross-functionally with Marketing, Communications, Medical, Sales, and agencies to ensure effective and compliant execution.
  • Ensure pharmaceutical compliance and ethical standards while upskilling marketing teams through training and best-practice sharing.

Requirements

Job Skills

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Global Clinical Project Manager

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Global Clinical Project Manager, you will be responsible for leading global clinical study teams and ensuring the successful execution of international Phase I–III clinical trials from study synopsis to study archiving. You will oversee timelines, budget, quality, CROs, vendors, and cross-functional teams while ensuring compliance with regulatory requirements and GCP standards.

Key Responsibilities

Job Skills

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Logistics Analyst II

posted by: spj_bot

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!

Location: Stafford, VA

 

Description:

Logistics Analyst II supports the Program Manager Expeditionary Radars (PM ExR) Program Management Office (PMO) by providing logistics support to the PM ExR APM Logistics in preparation for Independent Logistics Review Assessments (ILAs) and in preparing other logistics-related documents, as needed.

Required Clearance: An active DoD Secret clearance.

 

Primary duties will include:

Job Skills

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