IMVT Corporation is hiring a Remote Senior Manager IT Systems Admin
\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role:\n\nImmunovant is seeking an experienced IT System Administrator and Architect for our Veeva platform. In this role you will partner with Veeva and the business stakeholders to design, develop, implement and support Veeva solutions aligned with the best practices. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.\n\nKey Responsibilities: \n\n\n* Understand business requirements and convert them into functional and non-functional requirements\n\n* Lead end-to-end solutioning for Veeva platform in partnership with the business stake holders and third-party service providers. Configure and troubleshoot lifecycle, workflows, documents, and objects\n\n* Setup and manage document type tree/ hierarchies\n\n* Design and administer security roles including Dynamic Access Control (DAC) records as appropriate\n\n* Define and manage user access provisioning and de-provisioning for the Veeva platform\n\n* Manage Veeva platform and end-user licensing in partnership with the business/ functional stakeholders\n\n* Act as single point of contact for resolution of Veeva platform issues by coordinating with the business, IT Managed Services Provider (MSP), Veeva Application Management Services (AMS) and other third-party service providers\n\n* Analyze, implement, and document change and service requests.\n\n* Manage high priority requests and application downtime (planned & unplanned)\n\n* Ensure all Veeva modules remain fully validated during scheduled updates\n\n* Mentor and train functional area engagement teams on Veeva platform adoption.\n\n\n\n\nRequirements:\n\n\n* 7 to 10 years of experience at a life sciences, biotech, or pharmaceutical company providing business analysis and application implementation/ support in a fast-paced, demanding environment\n\n* Subject matter expertise in at least two Veeva Vault modules such as QualityDocs, RIM, eTMF, MedComms and PromoMats; experience in at least one of the regulated Veeva Vault modules a must.\n\n* Experience with Veeva CRM strongly preferred\n\n* At least two full life cycle Veeva Vault implementations\n\n* Certifications in Veeva Vault and Veeva CRM strongly preferred\n\n* Expertise in solution architecture design, technical integration design and Vault platform best practices\n\n* Thorough understanding of system validation and change management\n\n* BA/BS in Information Technology, business, or science\n\n* Strong attention to detail\n\n* Strong analytical, consulting, and problem-solving skills\n\n* Understanding of drug development from Phase 2 to launch\n\n* Multitasking ability to work on several projects\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n* Experience in Start-ups a plus.\n\n* Excellent communication and interpersonal skills.\n\n* Ability to work collaboratively with cross-functional teams.\n\n* Strong analytical and problem-solving skills.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required 10%\n\n\n\n\n \nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $170,000.00 - $185,000.00.\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Travel and Senior jobs that are similar:\n\n
$70,000 — $110,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
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When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Senior Director Controller
\nThe Role:\n\nReporting to the VP Finance, this position is responsible for the controller group, producing accurate and timely financial statements, overseeing the close process and all other accounting responsibilities such as T&E, chart of accounts etc. The Controller will be the ultimate reviewer of the CRO and CMO accruals. This role requires strong managerial capabilities to drive process improvement, system implementations and employee development.\n\nKey Responsibilities: \n\n\n* Finalize accurate and timely monthly, quarterly and annual financial statements (balance sheet and statement of income) in accordance with GAAP. Design and manage the monthly close process to ensure timely and accurate financial statements.\n\n* Design, implement and maintain a system of internal controls to ensure safeguarding of Company assets and accurate financial statements.\n\n* Establish and enforce accounting policies and procedures and operational strategies including the review and implementation of process and system improvements.\n\n* Ultimate reviewer of CRO and CMO accruals, overseeing improvements to CRO and CMO accruals processes to support growth of the business.\n\n* Manage a team including multiple direct reports and a larger group of indirect reports ensuring appropriate allocation of responsibilities and sufficient back-up support.\n\n* Serving as principal contact with independent auditors.\n\n\n\n\nRequirements:\n\n\n* Bachelor’s degree in accounting and Certified Public Accountant.\n\n* 15+ years of experience - some in public accounting (big four), at least 10 years of experience in the biotech industry and at least 6 years of experience as a controller.\n\n\n\n\n\n* Experience with financial reporting at a publicly traded company.\n\n* Experience with CRO and CMO +accruals is a must.\n\n* Demonstrated ability to organize an efficient and effective monthly closing process.\n\n* Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.\n\n* Team player, able to garner the respect of direct reports, peers, and superiors throughout the organization.\n\n* Strong communications and analytical skills.\n\n* Experience with NetSuite, Coupa, Expensify, Auxilius/Condor is preferred.\n\n\n\n\nWork Environment:\n\n\n* Remote-based\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (20%)\n\n\n\n\n \n\nCompensation is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $250,000.00 - $265,000.00.\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design, Travel, Accounting and Senior jobs that are similar:\n\n
$82,500 — $155,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
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When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Vedanta Biosciences is hiring a Remote Senior Systems Administrator
\nTitle: Senior Systems Administrator\n\nLocation: Cambridge, MA\n\nReports to: Head of IT Infrastructure & Operations\n\n \n\nAbout Vedanta Biosciences:\n\nVedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.\n\nThe Role:\n\nThe Senior Systems Administrator will support a Microsoft-centric computing environment consisting of Windows 2012/2016/2019/2022 servers for both corporate and GXP environments and associated Microsoft Cloud Technologies. This role will also assist in the support and administration of Azure, AWS, and Oracle fusion cloud. This position will report to the Head of IT Infrastructure & Operations. This role requires someone to be fully onsite, though some amount of remote work may be permissible in the future.\n\nHere’s What You’ll Do:\n\n\n* Administer, configure, and maintain Microsoft Azure services, ensuring the optimal performance and security of cloud resources.\n\n* Implement and manage M365 applications, including Exchange Online, SharePoint, and Teams.\n\n* Manage and maintain on-premises servers running Windows Server operating systems.\n\n* Administer storage solutions such as direct attached, SAN and NAS, ensuring data availability and integrity.\n\n* Design and implement solutions that seamlessly integrate on-premises infrastructure with Microsoft Cloud Technologies.\n\n* Implement and monitor security measures for both cloud and on-premises environments.\n\n* Conduct regular security assessments and audits and apply best practices to mitigate risks.\n\n* Manage user identities, roles, and access controls within both on-premises Active Directory and Azure Active Directory.\n\n* Implement and maintain multi-factor authentication and conditional access policies.\n\n* Utilize monitoring tools to proactively identify and resolve issues in both cloud and on-premises infrastructure.\n\n* Respond to incidents, conduct root cause analysis, and implement preventive measures.\n\n* Install, maintain, and upgrade server level hardware and software.\n\n* Conduct routine preventative maintenance on hardware and software systems.\n\n* Collaborate with cross-functional teams to understand business requirements and provide technical solutions.\n\n* Create and maintain comprehensive documentation related to systems architecture, configurations, and security policies.\n\n* Provide timely and effective support for servers and infrastructure during business hours as well as after-hours, as needed.\n\n* Assume additional responsibilities as requested.\n\n\n\n\nRequirements:\n\n\n* 5+ years of experience in a Microsoft IT environment, biotech industry and/or GMP experience preferred.\n\n* BS preferred, preferably in a relevant field such as Computer Science or Information Technology. Microsoft or AWS certifications a plus.\n\n* Experience with Microsoft M365 Suite, Azure, Intune, MFA, Microsoft System Center, Microsoft Hyper-V, Microsoft Exchange Online, Microsoft Defender Suite, Dell Servers, EqualLogic, and Synology SAN’s as well as Veeam backup solutions.\n\n* Scripting and automation skills using PowerShell or other relevant tools.\n\n* Technical experience working with Windows server computer systems.\n\n* Strong understanding of cybersecurity principles and best practices.\n\n* Possess excellent verbal and written communication skills with an ability to influence others.\n\n* Ability to function in a fast-paced, service-oriented environment. Ability to prioritize multiple projects daily and adjust to shifting priorities.\n\n* Strong planning, project management, and organizational skills.\n\n* Strong sense of urgency and a high-energy level.\n\n* Familiarity with analyzing, working with, and presenting data.\n\n* Possess a “hands-on” tactical approach.\n\n* Creative and proactive approach to problem solving.\n\n* Strong analytical abilities, resourcefulness, and attention to detail.\n\n* Ability to work independently and as part of a team with a proactive and positive style that fosters collaborative working relationships. Outstanding sense of customer service.\n\n* Deep personal commitment to integrity, excellent judgment, and the highest standards of ethics.\n\n* Must display the highest level of diplomacy, tact, and discretion, with comfort in handling and maintaining confidential information.\n\n* Ability to quickly get up to speed and master new applications and software is critical.\n\n* Ability to provide on-call and off-hours support as needed.\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Cloud, Microsoft and Senior jobs that are similar:\n\n
$60,000 — $90,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nCambridge, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Dyne Therapeutics is hiring a Remote Chief Information Officer
\nRole Summary:\n\nThe Chief Information Officer (CIO) is a key role responsible for defining and evolving Dyne’s technology and digital strategy, vision, and roadmap in line with the business strategy, to drive innovation, efficiency, and competitive advantage to enable organizational success, growth, and commercial readiness. This role requires an understanding of and deep experience with the full drug development lifecycle from research and development through commercialization. This role requires a strategic leader experienced with preparing an organization’s integrated technology infrastructure for commercialization and taking products to market. This leader is responsible for developing an IT roadmap, identifying, and executing on initiatives that drive tangible business outcomes that accelerate drug development timelines, ensure data integrity, compliance, and operational effectiveness.\n\nThis is a full-time position based in Waltham, MA without the possibility of being remote.\n\nPrimary Responsibilities Include:\n\n\n* Collaborate closely with cross-functional leaders to develop comprehensive strategies that drive business success and operational excellence, optimizing product development, and establishing commercialization processes\n\n* Align technology initiatives with the overarching business objectives, guaranteeing that Dyne’s corporate technology supports its operations and objectives including digital transformation, cybersecurity, and commercial readiness\n\n* Provide the strategies and technology solutions to enable the launch of products globally\n\n* Implement commercial, manufacturing and supply chain, and ERP business processes and systems\n\n* Lead and grow a strong global IT team, fostering a culture of innovation, collaboration, and continuous improvement, providing mentorship and professional development opportunities to team members to enable efficient and scalable operations, with particular focus to building of commercial capabilities\n\n* Define the operating model to enhance IT's capabilities\n\n* Continue to scale robust governance protocols to ensure product/platform compliance, policy development, and management of risks\n\n* Continue to scale a robust IT Security organization to protect Dyne’s assets and ensure global regulatory and privacy compliance\n\n* Evolve the cross-functional technology governance body to ensure alignment of technology and business goals\n\n* Develop an enterprise AI Strategy and prioritization framework and an enterprise data management strategy including retention and governance standards\n\n* Evolve and right size the ITGC, IT SOX, and SEC Cybersecurity controls\n\n* Responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems.\n\n* Partner with Finance to develop and lead the IT portfolio budget, ensuring sufficient resources are allocated for technology investments, returns are realized, and future investments are balanced across business needs, while providing a stable and efficient support operating model\n\n* Direct the development of the IT sourcing strategy and provide executive oversight for strategic vendor and partner relationship management\n\n* Provide strategic direction for cybersecurity program using a risk-based approach, direct internal and external services to execute on a proactive strategy, and ensure program agility to adapt to and evolving threat landscape\n\n* Drive commercial readiness in IT processes and related business processes to ensure business achieves timely benefits from investments\n\n* Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are optimized for business needs, operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines\n\n* Foster strong relationship[s, including proactive planning and cultivation of external partnerships\n\n\n\n\nEducation and Skills Requirements:\n\n\n* Bachelor's degree or equivalent experience in technology or related field\n\n* Twenty plus (20+) years related experience, including 5+ years as a strategic IT executive within a biotech\n\n* Commercial biotech build experience across commercial, manufacturing and supply chain, and ERP business systems in a strategic, head of IT or CIO role\n\n* Demonstrated initiative and ability to navigate ambiguity, and the ability to grow as the company scales in size\n\n* Experience building a commercial ready IT infrastructure, processes, and controls\n\n* Working expertise of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance\n\n* Expert knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization\n\n* Ability to translate business needs into a strategic IT roadmap, communicate that roadmap at all levels of the organization, and effectively implement that roadmap into operational success for the organization\n\n* Experience supporting all levels, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals\n\n* Expert knowledge of vendor management and technology business management processes and methodologies\n\n* Extensive experience with software development life cycle in regulated environment\n\n* Excellent communication skills (verbal, written, presentation) and ability to communicate well with stakeholders at all levels\n\n* Ability to lead both independently and in a team-oriented, collaborative environment\n\n* Ability to conform to shifting priorities, demands and timelines through analytical, and problem-solving capabilities\n\n* Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors\n\n\n\n\n \n\n \n\n \n\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Finance and Senior jobs that are similar:\n\n
$70,000 — $130,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
IMVT Corporation is hiring a Remote Director Clinical Procurement & Supplier Management
\n \n\nOrganization Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\nThis exciting, newly created role in Procurement will be responsible for leading the category management, sourcing, negotiations, and supplier management for all outsourced services related to the company’s clinical development pipeline and operations, while working cross functionally with internal stakeholders to ensure effective sourcing strategy, selection, contract negotiations, spend management, and resolution of supplier related issues. This leadership role requires keen business facing skillsets and acumen, as well as significant experience interfacing with, and managing, CROs and ancillary vendors across clinical development areas (e.g., Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Central Lab, TMF, etc.). Driving cross-functional collaboration with Immunovant’s leadership, this role will lead procurement initiatives, requests for proposals, supplier selection, contract negotiations, and ongoing business oversight for new and existing vendors.\n\n \nKey Roles and Responsibilities:\n\nBusiness Partnership:\n\n\n* Interface with and facilitate (as needed) across Immunovant’s functional areas to develop requirements and provide guidance/training to Business Owners (BOs) and stakeholders on the end-to-end sourcing process.\n\n* Partner early in cross-functional (Development, Legal, Finance, Program Management, etc.) business planning by effectively fostering relationships internally to maximize timely Procurement support for clinical programs, initiatives, and outcomes.\n\n* Establish clear external outcomes, deliverables/milestones, and payment structures within outsourced services and partners to effectively support the clinical programs and functions.\n\n* Ensure applicable vendors execute services as committed, and support issue resolution for clinical outsourced\n\n* Contribute and support the planning of clinical programs, supplier budgets, timelines, risk management, and financial implications for new or current programs.\n\n\n\n\n \n\nSourcing Process & Supplier Management Leadership:\n\n\n* Develop and execute sourcing strategies for outsourced services in the clinical pipeline.\n\n* Facilitate vendor selection across clinical development and operations teams (e.g. CROs and ancillary vendors).\n\n* Engage with BOs, stakeholders, vendors, and legal team to facilitate review of CDAs, CTAs, MSAs, Consulting Agreements, SOWs, Amendments/Change Orders, and other documents as required.\n\n* Lead the RFx and vendor bidding process for outsourced services, including RFP development, bid comparison analysis, bid defense meetings, and vendor scorecards, as well as manage any changes to existing programs (change orders, scope, etc.).\n\n* Manage the contracting process end-to-end working with key BOs, Legal, and Finance by optimal facilitation, review, and negotiations for outsourced services leveraging appropriate tools and guidance to support the functional areas.\n\n* Manage communication with outsourced vendors with respect to new and/or ongoing procurement support for programs, trials, etc.\n\n* Utilize expertise in total cost of ownership to facilitate and provide stellar negotiations leadership while focusing on “win-win” solutions between Immunovant and outsourced partners.\n\n* Manage supplier enablement/onboarding and purchase orders in system of record.\n\n* Support or lead (as needed) supplier relationship management needs, including metrics/KPI development, scorecards, etc. for business review meetings with key partners.\n\n\n\n\n \n\nProcurement Operational Excellence:\n\n\n* Foster clear, consistent, and open collaboration internally and externally.\n\n* Identify and pursue continuous improvement and constructive change to support higher levels of procurement execution, including development of best practices and timely communication of key learnings.\n\n* Support the issue escalation process at the operational level and ensure timely escalation to senior\n\n* Collaborate with BOs, Legal, and Finance to drive the development of key document templates, training / awareness, negotiation / escalation parameters, processes, systems & tools to support Procurement growth and the clinical pipeline.\n\n* Collaborate with the Clinical and Quality organizations on developing updated procedures on selection, onboarding, and maintenance of outsourced partners.\n\n\n\n\n \nRequirements:\n\n\n* Bachelor’s or Master’s degree with an emphasis on biotech/pharma, life sciences, outsourcing, supplier management, or business partnering.\n\n* 10+ years’ experience in the pharmaceutical/biotech/CRO industry preferred, with a minimum of seven (7) years of direct end-to-end clinical outsourcing\n\n* Must have experience in the procure-to-pay (P2P) process and working in a P2P system. Coupa experience is a plus.\n\n* Excellent interpersonal skills and demonstrated ability to be independently business facing and influence across all levels.\n\n* Ability to build consensus and strong partnerships internally and externally. Must be highly team oriented and comfortable working with cross-functional teams.\n\n* Excellent analytical skills and effective written and verbal communication skills.\n\n* Experience working on clinical trials and working knowledge of GCP preferred.\n\n* Knowledge in clinical budgeting/forecasting and eRFx systems a plus.\n\n* People management experience highly desirable.\n\n* Demonstrated ability to drive oversight, performance and relationship management with CROs and other clinical service providers.\n\n* Highly skilled in establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and focus on delivery and commitments.\n\n* Excellent leadership and influencing skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.\n\n* Flexibility to adapt to the dynamic needs of a rapidly growing biotech company.\n\n* Strong understanding of the drug development lifecycle.\n\n\n\n\n \nWork Environment\n\n\n* Immunovant’s headquarters is located in New York, New York. This position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment.\n\n* Domestic or international travel may be required (<10%).\n\n\n\n\n \n\n \n\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Consulting, Travel, Finance and Legal jobs that are similar:\n\n
$70,000 — $165,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alpine Immune Sciences is hiring a Remote Associate Director Clinical Documents
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences (AIS) is seeking an Associate Director-Clinical Documents (eTMF) to serve as an operational lead for management and oversight of the trial master file (TMF) system at AIS. This person works in partnership with the study teams in order to ensure trial documents are complete, high quality, and appropriately filed within the TMF system. \n \nDuties and responsibilities:\n· Establish strategy for development and management of paper and electronic Trial Management File (eTMF) system through project management and hands-on participation in the configuration and maintenance of the eTMF for each study.\n· Support authoring of TMF Management Plans and provide TMF Indices; work with study teams to check and verify these plans.\n· Provide guidance on best practices for clinical trial records handling, retrieval, and archival procedures.\n· Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to TMFs.\n· Participate in and oversee the quality control of documents (paper and electronic) submitted to the TMF.\n· Support the coordination of the transfer of study specific TMF from CROs into the AIS TMF, if applicable.\n· Educate and support study teams and designated study team content owners in understanding their TMF-related responsibilities, requirements, and expectations; act as an ad-hoc member of the study team, as necessary.\n· Act as a point person for study team TMF questions and manage close-out of TMF related issues.\n· Provide TMF metrics: timeliness, completeness, and quality of TMF documentation and content, and the risk level of outstanding items as requested.\n· Identify any corrective actions which must be assigned and addressed.\n· Provide document records to users (e.g., internal staff and/or auditors) for review including archived records. \n· Oversee the provision of the required documents at the time of regulatory authority inspection or internal audits.\n· Respond to TMF and non-TMF internal and external information inquiries related to clinical trial records.\n· Identify opportunities for continuous improvement.\n· Manage in-line QC functions for TMF documentation including site regulatory documentation to evaluate and report whether deliverables are completed per contracted services and are in compliance with all appliable local, federal, and international regulations, guidelines, AIS policies, SOPs, and work instructions.\n· Manage, mentor and train individuals reporting into this position, if applicable.\n· Actively support inspections and audits.\n· Resource planning to support TMF activities.\n· Perform other duties as assigned.\n \nQualifications:\n· Bachelor’s degree preferred, or equivalent knowledge/experience gained through a minimum of 8 years’ experience in the clinical trial setting required.\n· Must have strong knowledge of clinical drug development processes. \n· Understanding of the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials. \n· Experience in successfully working with TMF systems.\n· Demonstrated successful setup and management of TMF systems. \n· Thorough knowledge of CFR, ICH/GCP, and GDPR/data privacy requirements. \n· Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.\n· Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions. \n· Ability to anticipate issues and outcomes and respond strategically, proposing “outside the box”, goal-oriented solutions to challenges in alignment with project and company objectives and values.\n· Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.\n· Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.\n· Ability to review and analyze performance metrics through various systems.\n· Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.\n· Experience giving presentations in both department and multidisciplinary settings. \n \nEssential Traits: \n· Leads by example and learns from mistakes.\n· Effectively pivots to meet changing demands in priorities when business needs dictate.\n· Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.\n· Clearly communicates milestones, risks, mitigations, and essential feedback.\n· Values the input of colleagues. \n· Works efficiently without compromising quality.\n· Continually seeks self and team improvement.\n· Innovates and eliminates redundant, inefficient, and manual processes where feasible.\n\n\n#LI-remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position has a compensation range of $165,000 - $200,000. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Education jobs that are similar:\n\n
$60,000 — $100,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Cerevel Therapeutics is hiring a Remote Director Clinical Trials Transparency and Disclosure
\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder. \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\nThe Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevel’s transparency and disclosure activities (eg, clinical trial results postings, document redactions, and layperson results summaries). The Director will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.\n\n\n\nKey Responsibilities\n* Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team\n* Establish strategic plans and objectives for Cerevel’s global clinical trials transparency and disclosure capabilities\n* Lead the development of Cerevel’s overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary\n* Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations\n* Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends\n* Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (eg, plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teams\n* Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans\n* Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents\n* Lead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as needed\n* Ensure lean writing practices for regulatory documents such as clinical trial protocols, Investigator’s Brochures, and Clinical Study Reports to minimize CCI and PPD\n* Act as a subject matter expert during regulatory inspections\n\n\n\nRequired Qualifications\n* Minimum of 8 years experience in the biotech or pharma industry; including a minimum of 5 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience.\n* Experience writing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)\n* Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations\n* Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)\n* Experience working with CTIS preferred\n* Understands the clinical drug development process, including clinical trial design, operations and results analysis\n* Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support\n* Ability to evaluate and recommend process improvement and suggest/implement best practices\n* Outstanding oral and written communication skills\n* Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize\n* Flexible; adapts work style to meet organization needs\n* Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite\n\n\n\nDesired Qualifications\n* Recent neuroscience experience (within 2 years)\n* Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects\n* Prior experience working in Clinical Development, Clinical Operations, or Medical Writing\n* 2+ years’ managing direct reports\n\n\n\nEducation\n* Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:\n\n
$50,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Prilenia is hiring a Remote Director Senior Director Quality
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. \n\n\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\n\n\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.\nThe position will report to the Chief Operating Officer.\n\n\n\nRoles and Responsibilities:\n* Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.\n* Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.\n* Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.\n* Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.\n* Lead preparations for regulatory inspections and ensure ongoing inspection readiness.\n* Provide GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.\n* Identify any training requirements to meet the quality standards and ensure training is completed.\n* Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.\n* Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.\n\n\n\nQualifications:\n* 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies. At least part of the time should have been in a small to medium sized biotech or pharma company.\n* In-depth understanding and application of GxP principles, concepts, practices, and standards.\n* Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.\n* Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements. \n* Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.\n* Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.\n\n\n\nSkills:\n* Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.\n* Pragmatic and practical approach; understanding of “fit for purpose” approach. \n* Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.\n* Highly independent. \n* Experience working in virtual and global setting.\n* Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.\n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in Europe. \n* Flexible schedule with interactions across Israel, North America and Europe time zones.\n* Occasional travel is expected.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nEurope
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Tempus is hiring a Remote Principal Design Quality Engineer
\nPassionate about precision medicine and advancing the healthcare industry?\n\nRecent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.\n\nResponsibilities:\n\n\nSupport the development of new or improved In Vitro Diagnostics products and Laboratory Developed Tests as core team Design Quality Engineering lead; providing collaborative, solution-oriented technical guidance and support to the team\n\nAssist in the determination of appropriate deliverables and generating project timelines.\n\nSupports the sustainability and life cycle management of existing products\n\nEnsures compliance with quality system and regulatory requirements related to product and process\n\nProvide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development\n\nEvaluate adequacy of specifications for new or modified process designs.\n\nSupport product and customer requirement definition and development\n\nParticipate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.\n\nRecommends design or test methods and statistical process control for achieving required levels of product reliability.\n\nReviews and analyze performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.\n\nPerforms design change control activities including impact assessments, reviews, and approvals\n\nTakes lead role in CAPA, non-conformances, and planned deviations activities such as investigation, implementation, or verification of effectiveness as required\n\nSupports risk management activities in collaboration with the Risk Manager as they relate to product development and post market surveillance requirements\n\nReview the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities)\n\nSupport development master validation plans and reports.\n\nProvide technical support (subject matter expert) during audits (internal and third-party)\n\nPrepare documentation to support design history files and regulatory submissions ensuring documents are complete and accurate\n\nMaintain DHF and Propose, plan and execute improvement projects, as required for product sustainability\n\nDevelop/update departmental procedures and other controlled documents.\n\nParticipate in Material Review Board (MRB) and Change Review Board meetings, as required.\n\nTrain and mentor new employees. Provide guidance and direction to the team.\n\nPlans, executes, and works with minimal supervision and independent judgment\n\n\n\n\nQualifications:\n\n\nMust have experience working with all classes of Medical devices preferably IVDs in a QE role. Previous CDx experience a plus\n\nAbility to demonstrate proficiency in design of experiments, IVDD/IVDR requirements, Risk management file generation and remediation, problem analysis and resolution.\n\nDemonstrates leadership skills to handle sustaining product support activities involving Complaint investigations and Change controls.\n\nExtensive cross-functional team experience, including technical and non-technical work.\n\nStrong interpersonal and communication skills.\n\nStrong leadership skills and ability to work in a team environment\n\nHighly motivated hands-on engineer with a proven record of meeting timelines and goals\n\n\n\n\nEducation and Experience:\n\n\nB.S. degree in Degree in a chemistry, biology, or engineering discipline is a plus with 7+ years of experience working in a regulated environment in the in-vitro diagnostic, medical device, biotech or pharmaceutical industry. \n\nAdvance knowledge of applicable regulations including: 21 CFR Part 820, ISO 13485, ISO 14971\n\n\n\n\n\nExperience with process validation, analytical methods validation, and equipment qualifications.\n\n\n\n\n\nDemonstrated success in delivering results on several technical challenges.\n\n\n\n\n\nWorking knowledge of medical device domestic and international standards.\n\n\n\n#LI-SH1\n#LI-Hybrid\n#LI-Remote\n#LI-Onsite \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Engineer jobs that are similar:\n\n
$65,000 — $115,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nChicago, Illinois, United States
👉 Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
Alector is hiring a Remote Senior Director Biostatistics
\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of CNS diseases.\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n$250,000 - $290,000 a yearBase salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAlector was named on Fortune’s "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022. \nAmong the things you'll discover at Alectorfrom your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nUnited States
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