Director, Regulatory Project Management

About the Role

Title:Director, Regulatory Project Management

Brisbane, CA; or Novato, CA; or Somerville, MA; or Woburn, MA; or Remote- United States

Why Join Us?

Be a hero for our rare disease patients 

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. 

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

We are looking for an experienced Director, Regulatory Project Manager to support the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management tools and processes, and communication.  We’ll look to you to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist us in driving our pipeline of rare disease programs into the hands of patients.  You’ll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx’s offices or other locations on occasion as needed.

Responsibilities:

  • Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx’s development and post-marketing activities
  • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
  • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
  • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
  • Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio to most effectively support global regulatory pathways
  • Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress / delays, and risks / issues
  • Facilitate regulatory filing team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required)
  • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

Requirements:

  • Bachelor’s or higher degree in a related field with >8-10 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline; PMP certification a plus
  • Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development
  • Direct hands-on experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval / post-approval
  • Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality
  • Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization and passion for novel project management tool building
  • Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; direct experience with OnePager and Veeva Vault RIM is a plus
  • Travel to Ultragenyx’s offices or other locations on occasion, as needed #LI-CS1 #LI-Hybrid

APPLY HERE

Senior Embedded Software Engineer – QT6

About the Role

Title: Senior Embedded Software Engineer – QT6

Location: Brecksville OH US

Type: Temporary

Workplace: Fully remote

Job Description:

Senior Embedded Software Engineer (C++/QT6/Cloud Connectivity)

Duration: Full-Time, 3–6 Month Contract
Location: Brecksville, Ohio (Local candidates preferred, but remote will be considered)

Job Overview:
We are seeking an experienced Senior Embedded Software Engineer for a 3 to 6-month project with expertise in C++ and QT6 for embedded systems. The ideal candidate must have strong experience in troubleshooting and improving existing applications, ensuring optimal performance and reliability. You will also work on integrating embedded systems with cloud-based services. The role requires daily stand-up meetings as part of an Agile, Scrum-based development process.

Key Responsibilities:

  • Develop and deploy embedded software using C++ and QT6.
  • Troubleshoot and optimize existing applications, applying improvements as necessary to enhance functionality and performance.
  • Integrate embedded systems with cloud-based services for seamless connectivity.
  • Collaborate with the development team in an Agile environment, adhering to Scrum processes.
  • Participate in daily stand-up meetings to provide progress updates and address any blockers.
  • Ensure code quality through peer reviews, testing, and best practices.
  • Full-time commitment to the project for 3–6 months.

Requirements

Key Requirements:

  • Strong proficiency in C++ and experience with QT6 for embedded development.
  • Proven ability to troubleshoot, analyze, and optimize existing embedded applications.
  • Experience with cloud connectivity and integrating embedded systems with cloud services.
  • Familiarity with Agile development methodologies and Scrum processes.
  • Strong communication skills and availability for daily stand-up meetings.

Preferred:

  • Local candidates with the abilty to travel in Ohio as needed are preferred. Remote candidates will also be considered.

USA Firmware provides engineering and staffing services. No external recruiting support is approved for this opportunity.

APPLY HERE

Senior Media Manager, Paid Search

About the Role

Title: Senior Media Manager, Paid Search

Location: US

Job Description:

Remote, US-Based

Office locations: San Diego, CA & Denver, CO

Senior Media Manager, Paid Search 

Overview:

For over 14 years, 85SIXTY has been helping clients transform the way they reach, acquire and engage with their customers through an integrated combination of data, technology, cross-channel strategies, and creative thinking. Some might call us a full-service digital consultancy, but we like to think of ourselves as a partner that can both drive strategy and orchestrate delivery. Founded in 2010 by a veteran in retail, eCommerce, and digital, 85SIXTY was built around a consultative, high-touch approach that allows us to work across a broad spectrum of areas to increase our value to our customers. We are supporting today’s forward-thinking brands in their journey towards growth, whether that be financially, operationally and/or strategically. Solving whatever is thrown our way and translating it into simple solutions is at the core of 85SIXTY. We are looking for team members who fit that ethos.

85SIXTY is looking for a Senior Media Manager, Paid Search with experience building and managing Paid Search, PMAX, Demand Gen, YouTube and GDN campaigns across Google and Bing. This role handles the day-to-day management and optimization across a portfolio of clients. 

This person will be responsible for working with internal and client team members to define goals that are backed by strategic media plans. This role is also responsible for executing paid search strategies and tactics, as well as devising methods for accurately measuring performance against client goals. 

The ideal candidate will have superior organizational, task management and time management skills. They will also have a keen eye for attention to detail and a strategic outlook that leverages critical thinking. Excellent communication skills and comfortability presenting performance reports and quarterly business reviews to clients will also be necessary for success in this role. 

85SIXTY has a highly collaborative approach and, as such, your digital media expertise will be combined with the knowledge of other team members to create an integrated client strategy rooted in performance. Our team members are located across the US based on client locations/support needs. We have office headquarters in San Diego and Denver, and encourage a hybrid in-person schedule for employees who live near those locations to foster cross-team coordination.

We have a focus on active lifestyle brands, eCommerce and Travel & Hospitality. Experience working with these types of brands as well as a personal affinity towards these categories is a plus. At times our client initiatives require campaign oversight outside of ‘standard working hours’ (aka – weekend check-ins), so ideal candidates for this role will be open to instituting a flex schedule. 

Responsibilities:

  • Collaborate with team members in strategically creating full-funnel integrated marketing campaigns across all channels where paid search is a piece of the larger puzzle.
  • Build and manage all campaign types within the Google and Bing ecosystems.
  • Analyze real-time results and optimize campaigns to improve performance.
  • Deliver campaign performance projections and analyses with an eye towards future implications.
  • Proactively help and collaborate with the paid search team across clients for QA, observations, improvement opportunities, and campaign builds as needed.
  • Communicate with account management, planning and analytics teams to manage, maintain and enhance performance across assigned accounts. 
  • Communicate directly with clients on performance, optimization and project status.
  • Manage and mentor 1-2 junior members of the Paid Search team, providing guidance on best practices and campaign management
  • Aid in new business development by conducting comprehensive account audits, introducing industry best practices, and providing actionable recommendations to optimize performance and drive results for potential clients
  • Oversee the creation, optimization, and troubleshooting of product data feeds within Google Merchant Center to ensure accurate and comprehensive listings for Shopping and Performance Max campaigns
  • Monitor, share and test emerging industry trends in digital marketing. Meet with and vet potential media and technology vendors. 
  • Collaborate with organic search teams on keyword research and landing page insights as needed for the accounts. Leverage other cross-channel learnings to influence paid search strategy. 

Desired Qualifications: 

  • Experience managing Google and Bing campaigns against client goals with an average of 6-figure monthly budgets per account.
    • Experience with product feed configuration and maintenance preferred.
    • Management of MetaSearch campaigns is favorable but not required.
  • 6+ years of paid search buying experience.
  • Demonstrated ability to execute performance driven paid media campaigns.
  • Knowledge of the general activation capabilities of all available paid media tactics.
    • Please note any background managing campaigns across other channels/platforms.
  • Strong computer skills including Google Sheets (pivot tables and formulas), Google Docs, and Google Slides.
  • Ability to seamlessly juggle multiple priorities and maintain strong attention to detail.
  • Self-directed, proactive, and capable of creating solutions and resolving issues.
  • Strong interpersonal skills and ability to work with cross-functional teams.
  • Comfort operating in a fast-paced, entrepreneurial, and fun environment.
  • Certification in Google Ads and Microsoft Ads. GA4 certification is a plus.
  • Experience managing Paid Social campaigns is a plus. 

APPLY HERE

Paid Social Media Buyer

About the Role

Title: Paid Social Media Buyer (Enterprise)

Location: Remote Remote US

Type: Full-time

Workplace: Fully remote

Job Description:

100% Remote Position

Base Salary: $120-140K

Responsible for all aspects of executing paid digital media campaigns on networks like Facebook, Twitter, Snapchat, Pinterest, Google, YouTube, Bing, Outbrain, Taboola and more. This includes initial planning, implementation, monitoring, optimization, analysis and reporting.

This role will lead as the day-to-day subject matter expert (SME) for our clients, providing strategic recommendations, analysis, and reporting as well as responding to ad-hoc requests. You will be the one responsible to target customers, create compelling and engaging ads with our creative team and to deliver outstanding communication, service and campaign performance for our clients.

Additional Responsibilities include:

  • Assist in the development of media strategy and building paid media plans (including audience targeting and segmentation, messaging, budgeting, optimizations, etc.)
  • Leveraging our real-time data dashboards and a plethora of reporting tools, you will be tasked with communicating campaign performance to clients and creating a clear road-map for the future.
  • Analyze performance data and provide intelligent synthesis, interpretation and appropriate action plans based on conclusions
  • Continuously measure and optimize campaign performance while also establishing benchmarks and recommending future tests.
  • Communicate with clients on all elements of the campaign, including planning, performance, and project status
  • Prepare reports and present results to clients and management.
  • Maintain a high level of up-to-date knowledge of best practices and strategies in advertising networks (betas, ad network updates, innovation opportunities, etc.)
  • Use a data-driven approach to develop marketing strategies and marketing plans to support and achieve the client’s business objectives.
  • Build effective relationships with all clients
  • Gather data on consumer, competitor, and market conditions

Requirements

  • Bachelor’s degree in Marketing or related major required.
  • 5+ years of performance marketing experience in social is required.
  • Highly knowledgeable with automation tools (bidding and targeting), Google Analytics, and other management & ad creative testing tools.
  • Experience in scaling/increasing campaigns spends while maintaining or improving performance KPIs
  • Experience in maintaining and growing large spending accounts with significant optimizations and budgets
  • Ability to problem-solve and structure complex projects/plans with multiple stakeholders and deliverables
  • Ability to communicate effectively to all employee levels while understanding both the day to day and big picture
  • Ability to work in a fast-paced environment while managing time effectively

APPLY HERE

Senior Software Engineer ll, Visual Editor

About the Role

Title: Senior Software Engineer ll, Visual Editor

Location: US – Remote

Job Description:

Since 2016, dbt Labs has been on a mission to help analysts create and disseminate organizational knowledge. dbt Labs pioneered the practice of analytics engineering, built the primary tool in the analytics engineering toolbox, and has been fortunate enough to see a fantastic community coalesce to help push the boundaries of the analytics engineering workflow. Today there are 30,000 companies using dbt every week, 100,000 dbt Community members, and over 4,100 dbt Cloud customers. You can learn more about our values here.

This role is open to candidates located in the US and Brazil. Only candidates currently located in these countries will be considered.

About the Visual Editor Team: 

We are looking for a Senior Software Engineer II to join the Experience group. In this role, you will partner with product and design to create delightful and powerful tools for analytics engineers. We are building a tailor-made clients IDE, CLI, and a Low Code No Code (LCNC) platform that is deeply-integrated with the dbt ecosystem (including other dbt Cloud products), aiming to put more context at the fingertips of our users than they’re able to get in any other development environment. You will provide technical leadership to the team by doing. Data teams everywhere will use your work to create organizational knowledge and power their daily business decisions.

In this role, you can expect to:

  • Build and maintain dbt Cloud clients including the new LCNC platform, IDE and CLI app layer, backend services, performance, and scalability while relentlessly expanding its feature-set and capabilities
  • Manage trade-offs, priorities, and deliverables by applying your experience in bringing projects to successful completion
  • Work with product to define and instrument important usage metrics and KPIs for the cloud based clients
  • Enable teammates to build confidently and quickly via high-leverage tooling, mentorship, and your experience and knowledge of industry trends and practices
  • Define quality standards and drive the overall reliability of our services
  • Support the career development of team members by providing mentorship and coaching on design patterns, backend architecture, and technical decision-making

Qualifications:

  • Have 5-8+ years experience as a software engineer
  • Minimum requirement of Bachelors degree in related field (computer science, computer engineering, etc.) OR
  • Completed enrollment in engineering related bootcamp

You are a good fit if you: 

  • Have experience with using Python or Go to create scalable full-stack applications. For example, you have built services for applications with complex workflows
  • Enjoy working closely with product and design
  • Value interacting with end-users and deeply understand their needs
  • Understand how to make tradeoffs to ship useful features today without sacrificing long-term quality
  • Prefer to work in the backend, but have experience with the frontend and can reason about the end-to-end system
  • Have experience collaborating with multiple teams (e.g,. infra, upstream services, etc.) to drive projects and features to completion

You’ll have an edge if you: 

  • Have worked on an application similar to this one, such as a visual design tool, an analytics application, or an IDE
  • Have experience scaling applications, especially those with runtimes in Kubernetes and AWS</li>
  • Have experience working in a distributed company

APPLY HERE

UX – UI Designer

About the Role

Title: UX / UI Designer

Location: Remote, Worldwide

Job Description:

What are we all about?

We are a team of builders and researchers on a mission to empower enterprises and developers worldwide to access and build on decentralized systems.

Our expertise covers several domains: Ethereum and Starknet protocol engineering, layer-2, cryptography research, protocol research, decentralized finance (DeFi), security auditing, formal verification, real-time monitoring, smart contract development, and dapps and enterprise engineering.

Working to solve some of the most challenging problems in the blockchain space, we frequently collaborate with renowned companies, such as Ethereum Foundation, Starknet Foundation, Gnosis Chain, Flashbots, Forta Protocol, Lido, EigenLayer, Open Zeppelin, RISCZero, Aleph Zero, and many more.

Today, we are a 350+ strong team working remotely across 66+ countries.

View all our open positions here: https://www.nethermind.io/open-roles

Are you the one?

We’re seeking a talented UX / UI Designer for our Blockchain Block Explorer project. The ideal candidate possesses strong UX skills, robust UI capabilities, and an understanding of Web3 builders’ needs. Experience as a Web3 user is essential, and hands-on experience with Block Explorers is a plus. This role involves crafting UX/UI to make the blockchain world more accessible and appealing to the general public, while also improving technical features aimed at Web3 builders. If you’re up for this challenge, we’d love to have you apply and join our team.

Responsibilities:

  • Collaborate with product management and engineering teams to define, ideate, and implement innovative design solutions for product direction, visuals, and user experience
  • Execute all visual design stages from concept to final hand-off to engineering
  • Conceptualize original ideas to simplify complex design challenges
  • Create wireframes, storyboards, user flows, process flows, and site maps to effectively communicate design ideas
  • Present and defend designs and key deliverables to peers and executive-level stakeholders
  • Establish and promote design guidelines, best practices, and standards
  • Implement industry best practices by studying competitors and integrating optimal presentation of technical data for web3 builders and developers, with cooperation with the production manager to ensure efficiency.

Skills:

  • Strong UX design expertise with solid UI skills
  • Prior experience as a UI/UX Developer or similar role
  • Proficiency in UI design software and wireframing tools
  • Demonstrable UX portfolio showcasing a user-centered design approach
  • Deep understanding of design principles and best practices
  • Ability to collaborate effectively with cross-functional teams
  • Excellent communication skills and presentation abilities
  • Solid grasp of blockchain technology and its application in design
  • Proficiency in the blockchain industry is a must, alongside a personal interest in Web3 as a user.

APPLY HERE