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Director, Head of Drug Product Development and Manufacturing

  Director, Head of Drug Product Development and Manufacturing

  • Biopharmaceutical corporation is looking to hire a MS/PhD with 10+ years of pharmaceutical drug product development experience in gene therapy and biologics, including experience in early stage and late stage development programs, and launch/commercial stage products.

            Pay: High salary

            Job Type: Permanent

            Location: Telecommute 

            Travel Required: 10 - 30%

   Responsibilities

  • Leads formulation development for AAV gene therapies including drug product process development, packaging development, tech transfer support, and drug product characterization
  • Guides, designs and executes activities from early phase development through lifecycle management, for both gene therapy and therapeutic programs
  • Direct external CMOs for drug formulation development and drug product manufacturing
  • Supports GMP manufacturing including PIP, data monitoring and data analysis, troubleshooting manufacturing issues, and deviation closeout as appropriate
  • Maintains currency with applicable global regulations and industry standards. Prepare source documents to support regulatory filing, review the dossier

 Required experience

  • MS/PhD and 10+ years of pharmaceutical drug product development experience in gene therapy and biologics, including suspension, fill/finish, and prefilled syringe
  • Experience in early stage and late stage development programs, and launch/commercial stage products
  • Willingness to travel 10-30%
Clinical Development Head, Medical Device and other products

  Clinical Development Head, Medical Device and other products   

  •   An international biopharmaceutical corporation is looking to hire a Medical Doctor who has developed medical devices or biopharmaceutical products. 

        Pay: High salary, bonus, stock.

        Job Type: Permanent

        Location: Boston area

        Travel Required: 25%

    Primary role 

  • Lead a clinical development team.
  • Provide leadership & support on medical device/combination products programs in areas of clinical development and medical leadership within Medical Devices CoE. Supports development and execution of medical & clinical strategy for medical devices and combination products.
  • Assure clinical study design and data generated meets regulatory authority requirements, stakeholder requirements, and quality standards for medical devices and combination products
  • Contribute to the clinical study design for medical devices and combination products
  • Lead safety review input for medical devices and combination products
  • Understand closely device development and execution of clinical program and studies to support novel drug delivery devices and combination products.
  • Demonstrate in-depth knowledge of global regulatory/industry rules and guidance’s (e.g. ICH, GCP, promotional guidelines and labeling) to drive the strategic approach to medical device approval and clinical trial application process.

      Responsibilities 

  • Lead a team of clinical development professionals engaged medical device and combination product development
  • Plan strategically, implements and executes medical device programs and work streams
  • Work cross functionally to drive the strategy and collaborate to ensure implementation for device clinical programs or company initiatives
  • Represent medical devices and combination products perspective in the clinical sub-team of Global Product Teams (GPTs)
  • Collaborate with GPT Lead, Global Clinical Development Lead, Medical Director to ensure that all development and product support activities for medical devices are coordinated and consistent
  • Provide scientific advice within cross-functional device team leveraging scientific expertise and providing guidance in support of brands and product launches.
  • Review clinical protocols and clinical study reports for scientific and medical accuracy.
  • Participate in drug safety surveillance for development projects.
  • Provide expert medical advice / leadership to the project teams on medical devices and combination products for the development of Phase I-IV programs.
  • Engage with KOLs and PIs in peer to peer discussions to support clinical trials, advisory boards, and scientific exchange.
  • Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
  • Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
  • Contribute towards developing target product profiles and play a critical role in crafting the target device profiles.
  • Review and evaluate resource needs and influence for appropriate prioritization of programs
  • Provide input and rationale to influence cross-functional team
  • Ensure performance standards are realistically set and attained for internal and external resources
  • Engage with therapeutic area leadership and global clinical development leadership across the organization to integrate medical device and combination product knowledge with drug development knowledge within development process.
  • Align with team members from other functional areas regarding planning, implementation, tracking, analysis and report of milestones. Participates in due diligence activities
  • Remain up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
  • Participate in Research and Development, department and/or corporate wide task forces as appropriate
  • Provide credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.

     Required experience

  • MD w/8+ years exp in devices, pharmaceuticals or biotechnology industry
  • Clinical practice experience 3-4 years minimum
  • Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities
  • Experience with the Medical Device Regulation (MDR) and clinical evaluation
  • Experience in designing and conducting clinical trials
  • Experience with product development and design control in device and combination products 
  • Availability to travel up to 25% of time
ERP Practice Director

Pay: $125000 - $175000 base + commission plan

Job Type: Permanent

Location: open

Remote Option:

Travel Required: Yes

National healthcare consulting firm wants to build a healthcare ERP services practice. They have been successful in staff augmentation for HIS implementations, legacy support, interim CIO placement, project management and clinical advisory. They are looking to expand into ERP and are looking for an experienced Lawson or Peoplesoft sales professional to develop their hospital ERP business and then segue into more of an operations/BD role as the ERP Practice Director. This is an excellent opportunity for a successful sales professional who would like to move into operations and management.

Key to the job:

Experience selling ERP to hospitals

Data Warehouse Engineer

Pay: $90,000 to $120,000 negotiable

Job Type: Permanent

Location: TX, MA or remote

Remote Option: Yes

Travel Required: minimal

Health system has recently acquired 9 hospitals and is beginning a large data integration project. They need to hire two Data Warehouse Engineers as soon as possible.

 

Job: Data Warehouse Engineer 

Summary

Health System’s Software Development department is looking for a driven, pragmatic Data Engineer with real-world experience creating and maintaining enterprise-grade data solutions in the cloud. Utilizing industry-leading technologies and modern architectural concepts, the Data Engineer will provide expertise in multiple areas including data systems design, web-based workflows (ETL), advanced analytics, BI, Big Data, cloud storage and cloud processing.

Key Responsibilities

  • Design, build and implement enterprise-grade data solutions for large-scale, multi-tenant web applications
    • Produce high-quality, well architected solutions with an upfront focus on testing and long-term support
    • Ensure best practices and industry standard patterns are utilized whenever possible
    • Actively review existing code and other developers' work and provide feedback
    • Collaborate with developers and analysts on technical and functional designs
    • Work with the Product Owner and key stakeholders to fully understand functional requirements for enhancements and new products
    • Assist with project scoping, sprint and release planning
    • Work with QA and DevOps to perform unit/integrated testing and assist with development of automation strategies and tools
    • Collaborate with DevOps to help identify areas for performance improvement
    • Advocate Agile Software Development principles and practices
    • Participate and assist in conducting daily scrum meetings
    • Contribute to team body of knowledge by educating colleagues on industry developments and new client-side technologies

Qualifications

Education
• BA/BS/MS in Computer Science or related 4+-year technical degree

Experience
• 3+ years of experience in data engineering, or equivalent DBA + software development

Skills (Please note: Employer is looking for a solid mix of the following; employer doesn’t expect candidate to know all of these.)
• Solid background in computer science and mathematics
• Proficient with relational database management systems, preferably Microsoft SQL Server
• Proficient with SQL and preferably with T-SQL
• Demonstrated experience developing and supporting high performance batch extract, transform, cleanse and load processes using industry standard tools such as SQL Server Integration Services
• Experience with SQL Server Analysis Services and Data Analysis Expressions (DAX)
• Experience with BI tools such as SQL Server Reporting Services, Power BI, Tableau
• Experience with real-time data processing and integration in the cloud (IoT) with technology like Microsoft Azure Stream Analytics
• Knowledge and some experience with Big Data technologies such as Hadoop, HDInsight, Azure Data Lake
• Proficient in object-oriented programming concepts and development techniques
• Proficient with at least one OO language, preferably C#
• Experience with server-side frameworks and environments such as ASP.NET MVC, Python, PHP, Node
• Knowledge of ORM tools like Entity Framework, NHibernate, Dapper
• Knowledge of service-oriented architecture (SOA) and related architectural styles using REST, SOAP, RPC, XML,
• Experience with modern distributed version control systems like Git
• Experience with test, build, deploy (CI) software such as Microsoft Team Services, Bamboo, Jenkins, TeamCity, etc.
• Experience with an integrated development environment (IDE), preferably Visual Studio
• Experience working in an Agile-based development environment and knowledge of different methods such as Scrum, Feature-driven development (FDD) and Kanban

Also: Great to have knowledge of data management (querying, extraction, validation) within Lawson Financial application databases including General Ledger, Supply Chain Management/Materials Management, Accounts Payable, Human Resources, Payroll/Personnel.

General
• Strong analytical and decision-making skills
• Excellent oral and written communication skills
• Strong desire to seek out and learn new technologies and development practices
• Ability and willingness to adapt quickly to changing priorities and requests
• Ability to thrive under pressure and take control of urgent and demanding issues

About Development department

“HealthCare System is working on something profoundly different. We have an unwavering commitment to enhancing care delivery with the use of cutting edge technology and we are looking for highly skilled engineers with the desire to apply their talents to something genuinely valuable. It's time to truly advance the way we provide care. 

“The Software Engineering team is focused on advanced web-based application development utilizing industry leading predictive modeling and cloud computing to provide elegant, innovative solutions in a myriad of care settings. We believe in a culture of trust, open communication and regular collaboration that allows the cultivation of team harmony. Our environment values hard work, creativity and a devotion to learning. We love to be challenged, have an innate need to solve problems and enjoy unparalleled satisfaction from delivering beautifully crafted solutions.”

Infor Lawson Technical Analysts

Pay: to $96,000 plus full benefits

Job Type: Permanent

Location: Dallas area or remote

Remote Option: Yes

Travel Required: No

We are looking for Infor Lawson Technical Analysts (one for HR/Payroll area and 2 for FSCM; e.g., MM, GL, Inv., PO, AP etc.) for a leading, national health care system. These permanent health system jobs can be located in Dallas or in a remote location. All jobs offer competitive salaries and excellent benefits. This health system has acquired new hospitals and is upgrading, optimizing and installing Infor ERP.

Keys to the jobs:

  • Ability to do internal Lawson Application programming (i.e., a combination of MF Cobol, workbench tools, VB Script, Java Script, Jquery, HTML, PHP or C#) or have strong v11 experience. SQL programming (reports, queries) is preferred, as is interface/integration development

Education:  Bachelor’s Degree preferred. 

Experience (Type & Length): 5+ years of related experience.

Certification/Licensure: Certifications in Lawson/Infor are a plus.

Software/Hardware:  Knowledge of PCs, MS-Windows and Healthcare Information Systems.

Consulting Sales Reps

Pay: open - $100,000+ base

Job Type: Permanent

Location: open

Remote Option:

Travel Required: Yes

Consulting firm looking to add to their sales team. Looking for sales reps with a good track record of selling consulting contracts for staff augmentation to hospitals and health systems. Experience selling to Cerner hospitals is key.

Business Intelligence Developer

Pay: $80-110,000 DOE

Job Type: Permanent

Location: Boston area

Remote Option: No

Travel Required: No

Qualifications:

  • Knowledge and experience with database design principles including referential integrity, normalization, and indexing to support application development.
  • Strong understanding and experience in development activities for all aspects of Software Development Life Cycle (SDLC).
  • Understanding of agile processes.
  • Excellent interpersonal and communication skills.
  • Outstanding attention to detail and ability to meet deadlines.
  • Self starter with the ability to multitask in a dynamic work environment.
  • Proven experience developing business intelligence solutions in one of the following frameworks:
    • Business Objects
    • QlikView
    • Microstrategy
    • Cognos
    • Hyperion.
  • 5 years working in healthcare or life sciences preferred.
  • 7 years relevant work experience working in a business intelligence developer role.
  • 5 years experience in Microsoft SQL Server 2005 and 2008 RDBMS, Microsoft SQL Server 2005 and 2008 Integration Services (SSIS), Microsoft SQL Server Reporting Services (SSRS) and Microsoft SQL Server Analysis Services (SSAS).
  • Expert knowledge of SQL programming languages.
  • Exceptional candidates will have proven experience with some or all of the following technologies: web services, ASP.Net, C# , QlikView and familiarity of Microsoft Amalga.

Qualifications: Bachelors degree; Computer Science, MIS or Mathematics are preferred majors.

* Some key factors to help a candidate stand out would be experience working with Azure and EDW development.

Cerner Revenue Cycle Analysts

Pay: $75/hr - $95/hr

Job Type: Contractor or Permanent

Location: Anywhere

Remote Option: No

Travel Required: different options including mostly remote

Need experienced builders in any of the following:

 

Cerner Registration

Cerner Scheduling

Cerner Charge Services

Cerner CPA

Cerner CPM

Cerner HIM

Cerner Case Management

 

Start immediate

Long term