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We are seeking a Senior Medical Writer (Early Development) - EMEA.
As a Senior Medical Writer within the Early Development team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
Essential Functions:
Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies (Phase 1, 1b and 2a)
May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
May assist in program management activities. Identifies and resolves out-of scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
Represents the department at project launch meetings, review meetings, and project team meetings.

We are seeking an Experienced Clinical Research Associate (CRA).
Position Overview:
Performs and coordinates different aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness.
Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

We are seeking a Country Approval Specialist
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.
You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
Responsibilities:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy;
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
Provides project specific local SIA services and coordination of these projects;
May have contact with investigators for submission related activities;
Key-contact at country level for either Ethical or Regulatory submission-related activities;
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation;
Achieves PPDs target cycle times for site;
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable;
May develop country specific Patient Information Sheet/Informed Consent form documents;
May assist with grant budgets(s) and payment schedules negotiations with sites;
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines;
Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner;
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs;
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

We're Hiring Project Manager.
Join our mission to nurture every child's potential! Founded by Shai Silberbusch, First Step Method is a leader in innovative child development, specializing in programs for children with special needs.
Position: Project Manager - Special Needs Sector  
- Lead the publication of our groundbreaking book on children with special needs.
- Drive visibility and engagement through strategic publicity and social media management.
- Build and maintain transformative partnerships in the educational sector

We are committed to providing our customers with reliable and secure services so we are building out our newly formed Site Reliability Engineering team.
As one of the first joiners to our Reliability Engineering Team, you will be responsible for building and leading processes to ensure the reliability, availability, scalability, and performance of our cloud infrastructure that runs our databases.
You will collaborate with different teams like Control Plane, Dataplane, Core, Security, Support and Operations and guide them to design and implement scalable, secure, highly available and fault-tolerant distributed systems.
You will also own the areas of incident management and response, post-mortem analysis including running blameless postmortems, and continuous improvement of our services.
You will be leveraging your software engineering expertise to develop software platforms and tools to optimize the operational and engineering efficiencies of our Cloud.
This role is a unique opportunity to make a significant impact on our elastic, limitless scale, high-performance, serverless Cloud.
What will you do?
Collaborate with various engineering teams to design and implement scalable, secure, and highly available systems for us.
Establish and manage service level objectives (SLOs) and service level agreements (SLAs) for our Cloud.
Ensure all the infrastructure components in our Cloud (including Dataplane, Control Plane and Core) have monitoring and alerting in place to ensure timely detection and resolution of incidents.
Enhance and refine incident response processes and post-mortem analysis for any outages in our Cloud including working with the support team to communicate to the impacted customers.
Continuously improve the reliability and performance of our services.
Plan, enable, and drive Chaos initiatives across Engineering teams, based upon internal priorities.
Manage on-call processes to respond to performance and reliability issues, and establish best practices for coordinating escalation to resolve issues and minimize downtime.

We are looking for a Senior Sales Engineer.
As the Senior Sales Engineer, youll be key to championing our solutions for our customers.
This means well depend on you to use your creativity and expertise to transform ambiguous and often complex opportunities into significant deals.
In this role, youll also support the growth of the business by providing technical sales support for customers, including pre and post-client interaction throughout the sales process.
If you enjoy challenging projects, using new technologies to reach strategic business goals, and leveraging your entrepreneurial spirit, then this is the role for you!
Working Conditions:
Remote/work from anywhere
Up to 20% domestic travel may be required.

We are looking for a talented and experienced embedded Linux expert to join our team.
The position includes board bring-up and Linux/Android customization for our next-generation platforms.
Primary duties:
BSP development including U-Boot, kernel and driver porting and integration
Board bring-up as well as debugging and validation of new hardware

We are currently seeking a Sales Engineer to become an integral part of its team, dedicated to offering technical guidance and assistance.
The ideal candidate will have the chance to cultivate connections with pivotal clients and play a crucial role in advancing the sales of our products. If you aspire to collaborate closely with our sales, product and R&D team, delivering technical expertise, demonstrations, and solutions to our customers, we would love to hear from you!
What will you do?
Providing technical guidance and support to prospects and customers
Explaining products and services to customers and work closely with them to understand their technical requirements and translate them into effective solutions.
Assisting with product demonstrations, presentations and webinars.
Provide training to clients, both in person and remotely, to ensure they can effectively use our products.
Respond to technical inquiries and provide in-depth information to clients.
Support the closing of deals by addressing technical concerns and objections.
Gather feedback from clients and the sales team to help improve our products and services.

Required Senior Developer Advocate
Remote
Full-time
About The Position:
Join our dynamic R&D team and unleash your creativity as a Developer Advocate! We are searching for a talented individual who can collaborate closely with our Engineering, Product and Marketing teams to introduce our product to the global market.
If you're passionate about producing technical content and fostering engagement within the developer community, while establishing a vibrant ecosystem around an innovative product, then this role is tailor-made for you!
An early-stage startup, we are building products for busy developers like you and help them to move fast with confidence by merge, code, and test right inside the IDE.
What will you do?
Create technical content like blog posts, tutorials, open-source projects, and documentation to aid developers in running quickly with us. Ensure consistent tone and style on our website and social media platforms.
Own and drive the strategy for developer-focused conferences and events, from planning to execution, to increase brand visibility and developer engagement.
Evangelize our products and technologies through engaging presentations, webinars, and workshops targeted at developers and decision-makers within Enterprise organizations.
Cultivate a community of developers who love our product- build and maintain the developer community, actively participate in discussions, answer questions, identify, and engage with top contributors and followers.
Collect product feedback and ideas from the community through open conversations and use this valuable input to refine our offerings, prioritize feature development, and enhance the overall user experience.

We are looking for a Senior Technical Program Manager (TPM) capable of managing the growing demand to stop and prevent cyber-attacks. The ideal candidate should be skilled in project management, and able to handle multiple high-visibility, high-pressure engagements, and cases simultaneously, as well as many of the day-to-day operations of the team. TPMs are also responsible for organizing and ensuring that the goals of the team are met to respond in the midst of a security crises. In order to be successful, you should be comfortable executing complex tasks and objectives and working across teams to produce results in ambiguous situations.  
mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can thrive at work and beyond.
Program management of multiple simultaneous engagements and projects, delivering status reports and comprehensive project summaries to managers and stakeholders, and coordinating customer and team resources needed to respond and execute.
Support of customer and internal needs (both pre- and post-onsite deployment), clearly communicating objectives and guidance to stakeholders, and ensuring alignment with organizational goals and timelines.
To strengthen the team's threat detection/response/mitigation capabilities, drive continuous improvement initiatives through complete pipelines including:
Collection of feedback and data collected from each escalation or incident.
Identification of target areas (in processes, tools, or methodologies).
Prioritization amongst other feature requests.
Building out requirements.
Delivering against execution strategies
Maintain a high-level understanding of the security tools and processes used to thoroughly answer customer concerns.
Accountable for the quality of own work; to be delivered within agreed procedures and timeframes, focused on internal and/or external customer needs, and managed through ambiguity.
Additional operational assistance with the needs of a growing business, including new offering development, internal rhythm of business communications, and field training.
Deliver status reports and comprehensive project summaries to managers and stakeholders, and coordinating customer and team resources needed to respond and execute.
Embody our Culture and Values