Functional Oracle Cloud P2P Analyst

Atlanta, GA

6+ Months

This person should have extensive Accounts Payable Oracle EBS/ Cloud experience. This includes iExpense. The client needs someone who understands the Purchasing module end to end. This client utilizes the AP Automation tool Baseware and are looking for someone with extensive experience working with the software. This person needs to have strong communication skills as they will be working with the business users throughout the duration of the project.

Required:

Oracle Cloud/ EBS

Procure to Pay

Accounts Payable

iExpense

Basware

Project Management

Accounting

CMC Regulatory Affairs Consultant
Remote
12+ Months

Candidates should be located in USA. W2 candidates only

Duties and Responsibilities:

• Proactively manage CMC aspects including overseeing preparation and submission of CMC submissions - including clinical trial applications.
• Develop and assess CMC content to ensure it is complete, well-written, and meets all pertinent requirements.
• Stay up-to-date on current and evolving regulatory CMC requirements - apply this knowledge to assigned projects, and provide regulatory direction to the Quality, Manufacturing, Process Development and other functional groups and stakeholders.
• Head projects with cross-functional teams and acts as the main regulatory CMC contact for assigned projects.
• Participate in the design, development and execution of regulatory strategies, regulatory risk management and contingency plans.
• Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development.
• Assist with FDA and other global regulatory authority interactions for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications as well as other submissions with relevant CMC information.

Required:

• Bachelor's Degree or higher required (life sciences disciplines strongly preferred).
• 10+ years’ experience in life sciences
• 5+ years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
• Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.
• Cell and Gene therapy experience preferred.

Enterprise Azure Data Architect

Location - Trumbull, CT

6+ Months

2 Rounds of Interview

Only EST / CST based resources.

Required Skills – Synapse, Azure Data Factory, Azure Data Lake, ETL/Data warehousing, and SQL.

Required

A bachelor's degree in data analytics, data science, computer science, or a related field is required. Master's is preferred

A minimum of ten (10) years of progressively complex experience in a directly related area, during which both professional and technical capabilities have been clearly demonstrated

A minimum of seven (7) years of data & analytics solution architecting, design, and implementation experience with various relevant Microsoft platforms (predominantly with Azure), tools, technologies, patterns, and techniques

A minimum of five (5) years of experience must be as a Senior/Lead level with relevant job functions and technologies is required. Experience working closely with senior business leaders is a must

Hands-on experience using Data, Analytics, BI, and Visualization tools (SQL/No-SQL, Excel, PowerBI, SSRS, Tableau, etc), relational (SQL, Oracle, etc.) as well as non-relational databases (MongoDB, etc.), and all relevant data structures and schemas (Flat, Hierarchical, Network, Relational, Star, Snowflake, etc.) is a must

Azure Data Analytics, Data Science, or related cloud solutions certification is a big plus

Technical skills:

Thorough understanding and experience with Descriptive, Diagnostic, Predictive, and Prescriptive analytics

Ability to discover, analyze, and find data patterns and turn them into data products that can add value to the business decision making

Demonstrates ability to extract meaning from and interpret data using a variety of tools and methods from statistics and machine learning

Determines methods of statistical analysis and applies statistical techniques to determine measures of central tendency, correlation, sample size, the significance of differences, etc.

Experience with business or process analysis, and post-production support processes

Strong knowledge of data modeling, data designs, and data migration

Should be capable to support all phases of analytical development from identification of key business questions, through data collection and ETL

Knowledgeable in cloud and/or big data experience

Deep understanding of dimensional modeling, Designs of data warehouses, data mart, operational data stores, cloud data architecture, data security (including encryption, tokenization, vaults, etc.), and modern processing techniques using data pipelines

Familiarity with Azure (Synapse, Data lake, Data Catalogue, Databricks, Data Factories, LogicApps, etc.), O365 (Power Platform, especially Power BI), and SQL Server

Experienced in working with and exploiting big data; distributed computing; predictive modeling; mathematics; statistics; machine learning; story-telling; and visualization

Research pertinent literature in a designed project area and analyzes the applicability of concepts

Knowledge and experience with MS Office 365 suite, SharePoint Online, DevOps, GitHub, MS Teams, etc.

Experience with Agile projects and deliveries

General Business skills:

Ability to lead and mentor junior resources, if required

Clear communication to translate and explain business requirements to technology & vice-versa. Ability to produce and present presentations to the leadership An analytical & methodical mindset with a problem-solving attitude is extremely important for the success of this role

Clear, concise written, verbal, and presentation skills. Must be a team player who can earn a team’s respect quickly. Ability to take initiative and be innovative

Ability to complete projects and achieve results in an ambiguous work environment

Demonstrated organizational savvy and maturity, for working effectively across different organizational units and business groups