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SynMeta could be a friendly computer code company in California that was designed from the bottom up to be a good place to figure. we tend to work on fascinating comes with sensible individuals, treat everybody royally
SynMeta is an equal opportunity company. We have based our HR philosophy on the values of trust, transparency and competency. By choosing the right people for the client’s projects we have ensured not only project success but also achieve complete client satisfaction.
The non-stress environment at our workplace puts work and play put in the right balance. This has helped us to sustain each team member’s interest in work, greater productive and far lesser attrition rates. We provide our personnel good and congenial work environment, transport and canteen facilities. Facilities for indoor games were arranged at the staff canteen.
The challenges associated with each client’s project have put our project readiness in question. To counter this challenge effectively we have taken measures to enhance the readiness of personnel for the present and future project challenges.
The in-house training’s and expert interactive sessions have been made part of the employee orientation and on-job training activities. At SynMeta , skill development by conduct of job enrichment programs is a continuous activity.
The routine at SynMeta includes outings, celebration of birthdays, and arrangement of get-together parties at regular intervals of time. It has been integral to our work culture that good working conditions and healthy social life is a big booster of employee’s productivity, and keeps them focused at work.

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SAS Programmers (Wilmington, DE)

REQUIREMENT:

• Conduct statistical programming work of clinical data using SAS Version 9 or above
• H1B Sponsorship available
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Participate in the review of ‘Statistical Analysis Plan’ and other documents essential to the conduct of statistical programming work for clinical trials;
• Generate analysis data sets according to CDISC standard and SAP
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS. Conduct adhoc analyses.
• Validate programs and associated results produced by other programming colleagues.
• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, time line and deliverable are met;
• Develop standard SAS macros for efficient analyses of clinical data supervised by senior programmers.
• Function as lead programmer in individual project teams for oversight of timeline, quality, and delivery.
• For Levels II and III, participate in TLF shell preparation and review, and assist statistician for SAP preparation.

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Drug Safety Associate (Pea-pack, NJ)

REQUIREMENT:

• Support the submission and distribution of reports and relevant tracking Support distribution and tracking of distribution of Follow-Up letters;
• H1B Sponsorship available
• Support inspection preparedness activities policies and practices as per Company SOPs;
• Consistently apply Archiving policies as per Company SOP.
• Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
• Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
• Working knowledge of technology required for Patient Safety
• Establishing Dossier Plans for the assigned Global submission types as needed to support the life cycle of one or more products. The candidate will be responsible for: generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and time lines against established KPIs.
• Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• Support development of departmental work practices, process enhancements, and associated training materials.
• Develop/maintain associated process tools and relevant training documentation.

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Medical Writer Specialist (West Chester Pa or Raynham Ma)

The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas (i.e. spine, trauma, and cranio-maxiofacial areas) and/or medical devices (mostly mechanical implants and instruments such as plates, screws, meshes, cages, etc.) in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Note: I don’t think it is absolutely critical that the person has experience in these particular devices. It would be nice, but not absolutely necessary, as long as they have experience in mechanical type devices versus electrical / chemical / biological products. Also, many MDs would likely have a good appreciation of the therapeutic areas but if their specialties / experience is more pharmacological, they still don’t seem like the best fit. I also don’t think it is necessary to have an MD.

Key Job Activities:

• Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Performs scientific writing (e.g. abstracts, manuscripts, presentations).
• Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
• Ensures documents are produced in accordance with European law (i.e. Medical Device Directive (MDD), a.k.a. 93/42/EEC), procedures, internal and external guidelines (e.g. MEDDEV 2.7.1) – this is a key guidance document that I did not see once on the resumes, and electronic templates.
• Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
• Expert knowledge of clinical research, device– (drug side is minor & potentially negligible need in this business unit) development processes, regulatory requirements, good clinical and data management practices.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Performs MAUDE data base reviews
• Communicates with various departments (e.g. (European) Regulatory, Product Development (typically bioengineers or mechanical engineers), Clinical Research, Quality) to identify the necessary clinical and technical information.

Job Qualifications

Education
• Ph.D plus 1 to 2 years of related medical device experience (e.g. medical writing, regulatory affairs, clinical research, engineering)

• BS/BSN or MS plus 4 to 5 years of relevant medical device industry experience

Knowledge/Requirements

• Excellent English language skills, especially writing and proofreading.
• H1B Sponsorship available
• Clinical, scientific or research background, highly preferred.
• Experience writing CERs, highly preferred.
• Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
• Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
• Expert understanding of scientific or clinical research and methods.
• Understanding of statistical data and good data management practices.
• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).

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Business Analyst (LA, California)

REQUIREMENT
• The Regulatory Compliance IT team is looking for a Senior IT Systems Analyst. In this role, you will work with both IT teams and other internal organizations to gather requirements associated with Regulatory Compliance applications such as Actimize, FircoSoft, Bridger, WorldCheck and internal systems. The Senior IT Systems Analyst reviews and communicates business objectives and translates into technology specific requirements. The positions will also collaborate closely with business and technical resources in support of various testing activities and phases. This position will be responsible for leveraging advanced analytical, research and problem solving skills to define innovative technology solutions in cooperation with developers to meet business objectives.
• The Senior IT Business Systems Analyst will also perform analysis and design activities on complex IT initiatives by eliciting, defining, validating and translating business functional, non-functional and information objectives, then validating them when implemented, as well as preparing status updates on a regular basis to all stakeholders.
• The ideal candidate will possess a deep and broad understanding of Information Technology best practices and processes. Additionally a strong and demonstrated strength in analysis and support of a broad spectrum of BSA/AML and Regulatory systems is required.
• 30% Illicit, analyze, validate and manage technical requirements definition, flows and deliverables for projects. Perform this by working with business partners to understand work effort requirements and then translate into IT actionable tasks.
• 30% Working closely with the IT team to deliver business requirements. Partner closely with technical teams supporting data movement, application development and testing. Diligently support and lead where needed various activities between the teams to ensure the business and technical requirements and objectives are met. Ensure appropriate project documentation is compiled and proper review and approvals from respective teams as gathered and collated.
• 10% Contribute to the the overall system(s) design. Evaluate current processes and procedures to ensure relevance and accuracy. Make recommendations for changes and keep documentation current.
• 10% Perform as the subject matter expert on the various AML systems and processes assigned. Inclusive of this is gathering a deep understanding of the data within the systems and business processes supported by the system(s).
• 10% Build critical working relationships with the business and users communities through gathering a thorough understanding of the business models and processes employed.
• H1B Sponsorship available

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QA Engineer - Mobile testing (Redwood City, CA)

• End Client/Customer: EROS:
• 4+ years in QA
• Manual testing – mobile app
• Strong communication and documentation skills
• White box testing
• Experience with Linux Commands.
• Knowledge of Quality Assurance principles, methods and processes
• Solid understanding of mobile technologies and applications
• 2+ years of experience in mobile application testing or equivalent software technologies
• Experience working in an Agile environment
• Significant experience designing and executing QA black box test conditions
• Experience testing and validating functionality, user flows and visual designs
• Ability to learn quickly and work in a fast paced environment with quick turn around
• Highly organized and detail oriented
• Automation
• H1B Sponsorship available

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Test Automation Engineer (Jamaica Plain, MA)

The Test Automation Engineer will work for 6+ months as part of the project team which consists of developers on the IT side and Informaticions on the user side. He/she will review and automate a catalog of ~400 test cases (Regression, UAT…) whenever feasible.
Deliverables:
• Feasibility Analysis.
• Strategy including prioritization to automate existing test cases with SELENIUM.
• SELENIUM scripts to automate manual test cases.
• Coach the development team in writing SELENIUM scripts.
• Provide guidance and rules to determine which test cases can and should be automated and which not.
• Creates reports containing test metrics and status for the management team.
• Assesses quality of existing scripts on a different project.
Requirements:
• CSTE or CSQA certification.
• H1B Sponsorship available
• Minimum of 5 years of professional QA experience.
• Minimum of 2 years of professional experience using SELENIUM.
• Familiarity with formalized test methodology and associated artifacts.
• Knowledge of J2EE development environment.
• Excellent communication and facilitation skills.
Desirable:
• Knowledge of Agile Testing Practice
• Knowledge of relational database design structure concepts.
• Knowledge of SQL statement syntax.

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UX Designer for Our Mobile Apps (LA)

Summary:

The Senior Web Designer is responsible for the design, development and maintenance of web applications and components. The primary focus is to support and maintain the envato.com public web site. A deep understanding of the site architecture (both functional and technical) and how it supports the business vision and processes will be vital. Will identify, design and implement web site enhancements by working closely with a team of internal marketing/sales stakeholders, and with external digital ad agency and application vendors. Adheres to KBHIT processes/methodologies including request management, application development and release management.

Duties and Responsibilities:

Works closely with a team of internal marketing and sales stakeholders as well as with and external digital ad agency and application vendors to define a compelling design for the site that is maintained throughout the site navigation, content and features. Employs a variety of methods to present conceptual designs/solution (wireframes, mock-ups, detailed visual designs, and graphics).

Requirements:

  • Bachelor’s Degree in Management Information Systems, Business Administration, Computer Science or equivalent experience
  • Minimum 5 years’ experience in web user interface design and web application development with management responsibilites.

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Senior Web Designer (LA)

Summary:

The Senior Web Designer is responsible for the design, development and maintenance of web applications and components. The primary focus is to support and maintain the envato.com public web site. A deep understanding of the site architecture (both functional and technical) and how it supports the business vision and processes will be vital. Will identify, design and implement web site enhancements by working closely with a team of internal marketing/sales stakeholders, and with external digital ad agency and application vendors. Adheres to KBHIT processes/methodologies including request management, application development and release management.

Duties and Responsibilities:

Works closely with a team of internal marketing and sales stakeholders as well as with and external digital ad agency and application vendors to define a compelling design for the site that is maintained throughout the site navigation, content and features. Employs a variety of methods to present conceptual designs/solution (wireframes, mock-ups, detailed visual designs, and graphics).

Requirements:

  • Bachelor’s Degree in Management Information Systems, Business Administration, Computer Science or equivalent experience
  • Minimum 5 years’ experience in web user interface design and web application development with management responsibilites.

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