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senior manager, regulatory sciences (biotech/pharma)

Our biotechnology client has an immediate need for a Sr. Manager, Regulatory Science on a full-time basis in their Los Angeles location.  You will primarily support the US regulatory aspects of regulatory affairs for their lead product, research & summarize regulatory intelligence, provide regulatory input for regulatory submissions and work closely with colleagues to compile & review submissions for completeness and quality.

 

This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.

 

Responsibilities:

  • FDA contact for assigned projects.
  • Participates in global regulatory team, study teams, and ad hoc meetings as a regulatory affairs representative.
  • Offer submission strategies and identifies potential regulatory risks.
  • Tactical support for the timely preparation, editing and review of submissions, including Health Authority Meeting Requests & Briefing Documents, IND/CTA amendments, NDAs/NDSs/MAAs and their respective amendments/supplements
  • Support creation of cover letters, forms, and other required documentation for applicable submissions including drafting of proposed US labels.
  • Liaises internally and externally on applicable submission documents including the uploading and routing of documents in EDMS and the review of documents.
  • Assist in the global strategy for potential new markets and regulatory intelligence for indications of interest.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Provide interpretation of new regulations, guidance documents and directives; and advises on impact on internal programs.
  • Compile and maintain global regulatory documentation databases or systems.
  • Archive global submissions and regulatory correspondence.
  • Complete CTA Questionnaires for all studies on monthly basis.
  • Build and maintain spreadsheets that will calculate and organize business metrics as required.
  • Compose or update standard operating procedures, work instructions, or policies as needed.
  • Support Global MAA with Regional Partners
  • Manage ex-US CTAs through local regulatory consultants
  • Excellent listening and communication skills, with an ability to accept direction and feedback

Required Skills:

  • Minimum of Bachelor’s degree
  • Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
  • Had prior US Regulatory Lead, FDA contact, or directly related experience, preferably in the oncology therapeutic area

 

 

Filed Under: Uncategorized

Principal / Senior Software Engineer (San Francisco OR Seattle)

This position could be filled either in our client’s San Francisco HQ office or their Seattle office.

 

Primary responsibilities:

  • Building high performance systems for personalization, optimization, and targeting
  • Coordinating with a research team to move prototypes into production
  • Contributing to algorithm design, research and scalability
  • Building systems with Hadoop and Spark (MLib, GraphX), Mesos, Marathon
  • Designing and implementing data pipelines to support data needs for machine learning (both batch and online), reporting, monitoring and alerting. (Crunch, Cassandra, HBase, Hive, Presto, no-SQL databases)
  • Software engineering in Java and optionally Scala
  • Working with rapid development methodologies such as Continuous Delivery and SCRUM
  • Automating tests at various levels, including end to end integration testing with synthetic known data, unit testing with JUnit, performance testing and tuning
  • Coordination with internal and external teams
  • Mentoring junior engineers

 

Minimum requirements:

  • BS/MS in CS, Electrical Engineering or foreign equivalent
  • At least 5+ years of software development experience
  • Expert in Java, Scala or any other object oriented language
  • Experience with HDFS and Spark
  • Proficient in data modeling with advanced knowledge of data structures
  • Additional language skills for scripting and rapid application development

 

Desired skills and experience:

  • Production experience with big data (high volume, high velocity) systems
  • Knowledge of numerical programming, data science, machine learning and/or statistics a strong plus
  • Familiarity with UNIX (systems skills a plus)
  • Working in a distributed environment and has dealt with challenges around scaling and performance

Filed Under: Uncategorized

.NET ENGINEER

The .Net Engineer implements and maintains core entertainment-based accounting and payroll applications. The position works closely with senior management, business analysts, and lead or principal software engineers to design, develop, and maintain software components and products that support business applications.

Responsibilities

  • Collaborate with Business Analysts to define requirements.
  • Create technical designs and architectural documents for implementation.
  • Learn complex relational database models and work within an established multi-tier application framework.
  • Lead and mentor a team of developers, perform code reviews, and hold daily scrum meetings.
  • Design, develop, implement, and maintain software components.
  • Identify opportunities to improve functionality.
  • Write complex SQL queries and stored procedures on SQL Server 2014.

Requirements

  • 7+ years of developing complex .NET-based applications using C# and .Net 3.5+.
  • 7+ years of developing applications using SQL Server 2008–2014.
  • Expert in .NET frameworks and features.
  • N-Tier application development expertise.
  • Strong analytical skills, attentive to detail, and excellent problem solving/troubleshooting.
  • Flexible to meet the demands of a rapidly changing environment.
  • Expert in developing in an SOA architecture (WCF, Web Services, REST).
  • Ability to work with teams in remote locations.
  • Performance expertise dealing with large datasets.
  • Skilled in ASP.NET, AJAX, JQuery, HTML, JavaScript, CSS, IIS, and JSON.
  • Experience in any of the areas below considered a plus:
    • NetTiers framework, ETL (Pentaho/SSIS), Deployment (InnoSetup).
    • Multi-tenant systems.
    • Windows Forms application development.
    • CodeSmith or other code generation frameworks.
    • Cloud Computing – Azure/AWS.
    • Visual Studio Online, Infragistics, Log4Net, Splunk, Symmetry Tax Engine.
    • Migration of .Net Frameworks, Conversion of SOAP to WCF.

Filed Under: Uncategorized

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13636 Ventura Blvd. Suite #425
Sherman Oaks, CA. 91423
818.762.0800
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