Xilis, Inc. is hiring a Remote Manufacturing Assembly Technician
\nXilis, Inc. is an innovation-driven biotech company developing its proprietary MicroOrganoSphere (“MOS”) Technology for functional precision oncology. Xilis’ MOS Technology enables rapid and scalable generation of patient tumor models that retain patient-specific tumor biology and tumor microenvironment, representing one of the most translationally-relevant ex vivo technologies for precision oncology drug discovery and development. Located in Research Triangle Park, Durham, NC, Xilis is building a functional precision medicine platform that incorporates scaled multi-modal profiling of therapeutic activity and AI/ML-enabled analytics to catalyze functional precision medicine drug discovery, development and diagnostics. Collectively, Xilis aims to harness its MOS Platform to enable development of the most effective therapeutics and guide them to the right patients at the right time.\n\n\nThe candidate will be a member of the Device Engineering team and will be a key contributor to successfully growing our business. The Manufacturing Assembly Technician (contract) will follow assembly drawings, instructions, and bill of materials to assemble our primary instrument and produce related consumables used in its operation. This is a unique opportunity to apply skills and experience in a business that will revolutionize cancer patient care.\n\n\nWe are looking for an individual who has a strong mechanical assembly and wiring background to help build, test, and inspect Xilis’ primary instrument, along with manufacturing and assembly of custom instrument consumables. The instrument is a benchtop medical laboratory device built from over 1500 custom and off-the-shelf parts, and the wiring consists of crimping pins, soldering, and assembling connectors for dozens of custom cables. We work in a fast-paced environment and are continually improving the design and performance of systems. Participating in the development and advancement of our instrument by making suggestions and applying previous experience is encouraged and appreciated.\n\n\n***This is a 6-12 months contract opportunity***\n\n\n\nResponsbilities\n* Assemble instruments according to the assembly drawings and instructions, ensuring that parts and subassemblies are manufactured correctly and fit properly when putting the product together.\n* Manufacturing of instrument consumables through use of laser cutters and micro-CNC machines.\n\n\n* Ensure that parts and products meet quality standards by following established guidelines to measure, test and inspect the product assembled.\n* Test finished products for defects and perform installation quality checks.\n* Requisition parts and materials on the approved Bill of Materials for instrument assembly.\n* Manage inventory following established guidelines and procedures including labeling and locating parts, picking parts from appropriate locations in specified quantities to fill kits or bins, delivering parts to work areas, and recording and communicating inventory levels.\n* Maintain a clean and organized work area and maintain all equipment according to maintenance plans and established procedures.\n* Mechanical assembly of small components.\n* Examine connections for correct fit.\n* Familiarity with basic electronic assembly or previous experience is required.\n\n\n\nRequirements\n* High school diploma or general education degree (GED)\n* 4-6 years related experience and/or training assembling complex instruments (electronics, mechanical sub-assemblies, pneumatics or other); or equivalent combination of education and experience\n* Must have the ability to problem solve and troubleshoot problems both independently and as part of a team.\n* Follow technical instructions, interpret engineering blueprints and technical terms\n* Be a collaborative team member\n* Work independently with limited amount of supervision\n* Ability to create and maintain detailed and accurate documentation\n* Ability to lift 50lbs\n* Ability to stand for the majority of an 8 hour day\n\n\n\n\n\nXilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!\nXilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!). \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Design jobs that are similar:\n\n
$95,000 — $125,000/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\nDurham, NC
👉 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 Senior Director Regulatory Affairs
\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\nThe Senior Director, Regulatory Affairs is a leader, who provides vision and direction in a fast-paced, dynamic, and competitive drug development environment. They report to the Executive Director of Regulatory Affairs and are responsible for contributing to the global company regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of Alpine’s therapeutic candidates. \n \nDuties and responsibilities:\n \n•Lead strategic regulatory activities to support cross functional product development teams in alignment with corporate and program goals.\n•Serve as the global regulatory lead for select development programs.\n•Develop and implement regulatory strategy for INDs, CTAs, BLAs; MAAs, NDAs; identify opportunities globally for expedited development. \n•Provide strategic regulatory input on clinical, including therapeutic indication(s), study designs, patient populations, pediatric development; CMC; and nonclinical development. \n•Prepare and coordinate authoring, review, and submission of high-quality regulatory documents, including Information Requests, IND/CTA submissions, BLAs/MAAs/NDA, Annual Reports/DSURs, briefing books for health authority interactions, clinical documents to ensure they are complete, well-written, and meet all relevant regulatory requirements. This may involve writing relevant sections of documents.\n•Lead regulatory aspects of clinical study executing including management of correspondence with health authorities and coordination with partner companies and vendors.\n•Ensure compliance of all Alpine activities with applicable global regulations, standards, and clinical practice guidelines. \n•Monitor regulatory developments within the industry globally, evaluate impact to Alpine’s programs, and provide actionable guidance to internal and external partners to adapt to and address the developments. \n•Identify and communicate with senior management and cross-functional teams regarding potential regulatory issues; propose risk mitigation strategies and resolutions. \n•Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise.\n•Supervise, mentor, and help develop the strategic and technical expertise of regulatory colleagues within the Alpine organization.\n \nQualifications:\n \n•BS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.\n•10+ years of experience in biotechnology or pharmaceutical industry with hands on experience and knowledge of the drug development process and regulatory submission and approval process required.\n•Experience working in a regulatory affairs leadership role with sole responsibility for a clinical-stage development program and marketing authorization applications, with experience as a manager/supervisor. \n•Late-stage clinical development experience and experience submitting BLAs, NDAs, and/or MAA is required.\n•CMC experience, including biologics, is desired.\n•In depth knowledge of FDA, EMA, and ICH regulatory requirements and guidelines specific to the areas of clinical research, nonclinical testing, product development, and labeling is required. \n•Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.\n•Demonstrated ability to develop/maintain strong working relationships with cross-functional internal and external teams, participate on and/or lead multifunctional teams, manage, and prioritize multiple projects and work independently.\n•Prior global regulatory experience required; experience in Asia Pacific and Latin America is desired.\n•Strong vendor management experience is desired. \n•Therapeutic area experience in autoimmune disease is desired.\n•Must be detail-oriented while also retaining the ability to see the big picture.\n•Must have effective technical/analytical skills to identify and solve problems independently.\n•Must be able to work in a fast-paced, timeline-driven environment.\n•Should have experience writing and developing SOPs.\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 is a Director level position with a compensation range of $230,000 to $270,000. Note that there is a strong preference for candidates to 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, Education, Senior and Marketing jobs that are similar:\n\n
$70,000 — $105,000/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\nRemote
👉 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.
Adverum Biotechnologies, Inc. is hiring a Remote Director Senior Clinical Development
\nThe Director/Senior, Clinical Development will provide scientific and technical expertise for assigned clinical programs and will bring experience in designing and conducting clinical trials. This position has primary responsibilities for setting strategy across the clinical development program, oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies. \n\n\n\nWhat you'll do: \n* Contribute as team leader and author in protocol development, clinical study reports, investigator brochures, periodic safety update reports, international regulatory submissions, interactions with US and Global Health Authorities\n* Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, contributes to scientific publication of study results\n* Serves as CD liaison/point-of-contact for inquiries from clinical operations, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation\n* Represents CD in sub-teams and addresses CD study or other program-specific questions, develops and provides input for clinical presentation slides and other materials for meetings and ongoing communication\n* Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, health authorities, scientists and KOLs, as well as internal groups, including regulatory research, operations, legal and business development\n* Participates in ongoing enhancements and development of team processes, structures, and tools\n* Develops and mentors study team members\n\n\n\nAbout you: \n* MD, PhD or OD required; PharmD with relevant experience may be considered\n* 5-10 years of clinical research and/or clinical development experience within the pharmaceutical or biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) Gene therapy and/or ophthalmology (retina) experience preferred.\n* Ability to proactively predict issues and solve problems\n* Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team\n* Diplomacy and positive influencing abilities\n* Committed to developing and mentoring team \n* Therapeutic area knowledge relevant to mechanism of action and retinal drug development\n* Understanding of US and Global Regulatory requirements\n\n\n\n\n$225,000 - $275,000 a yearThe salary range for this position is $225,000 USD to $275,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.\n\nAbout Us\nAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.\n\n\nAt Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation\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 Legal jobs that are similar:\n\n
$60,000 — $145,000/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\nRedwood City, CA
👉 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.
Synthego is hiring a Remote Senior Strategic Account Manager
\nDo you believe that bioengineering represents the future of medical diagnostics and therapies, with CRISPR/gene editing serving as just the initial breakthrough? We are seeking an experienced, consultative sales professional to join our team, someone who finds inspiration in our mission and can contribute to our established start-up's collaborative, dynamic, and innovative culture. We would like to hear from you if you're enthusiastic about articulating the value of Synthego's cutting-edge platform technologies.\n\n\nAs a Senior Strategic Account Manager, you'll play a pivotal role in driving the growth of our Cell and Gene Therapy business by positioning our Research Use, IND enabling, and Clinical product portfolios. You'll identify, nurture, and grow key client relationships in this position. As an individual contributor, you'll actively engage in outbound sales and prospecting initiatives while collaborating closely with our internal support teams to ensure seamless execution. This role offers an exciting opportunity to directly impact and drive our business forward in the rapidly evolving biotech landscape."\n\n\n\nWhat You'll Do: \n* Serve as the primary point of contact for existing and new accounts ordering Synthego’s RUO, IND enabling, and GMP product lines for the Western US Region \n* Conduct prospecting activities to build a funnel for preclinical and clinical business.\n* Identify clinical upsell opportunities and drive revenue growth.\n* Own the entire opportunity funnel, from opportunity creation to purchase order receipt, while collaborating with the RUO/GMP Product, Quality, and Operations teams.\n* Provide customer and market feedback to the product management and marketing teams to support the expansion of the product roadmap and commercial strategies \n* Leverage emotional and social intelligence to effectively interact with internal and external customers, fostering positive relationships and driving team collaboration across various functions.\n* Learn and evangelize the value proposition of Synthego’s Bench to Clinic synthetic biology products, supporting and improving the cell therapy process through data-driven decisions.\n* Focus on revenue growth, with the goal of establishing Synthego as the primary supplier for genome editing products and services.\n* Continuously build strong relationships with established commercial companies, non-commercial institutions, and universities with cell therapy programs, from bench scientists to senior leadership.\n* Map account structures, including functional areas and personnel, and identify and manage client profiles critical to closing a deal – influencers, budget owners, decision-makers, executive sponsors, etc.\n* Travel approximately 25% of the time for on-site customer meetings.\n\n\n\nAbout You: \n* 5+ years key account / large corporate technical sales experience in biotechnology / Life Sciences or a cell therapy company.\n* Strong experience in sales process management and professional sales techniques (e.g. Challenger, SPIN, Miller Heiman), negotiating 5-8 figure contracts and supply agreements, developing and executing strategic and tactical plans for account growth\n* Strong existing network of contacts and working relationships within large biopharma accounts within your assigned territory that can be leveraged to find the ideal customers for Synthego’s GMP product and service offering\n* Strong working knowledge of the Cell and Gene Therapy process\n* Deep cell biology knowledge needed to understand the customer research focus. Able to find areas of fit with the Synthego platforms, manage the technical conversation and sales process. Note that Synthego does not use an FAS support model.\n* Collaborate closely with Marketing, Sales Operations, Product Management, Technical Support, Research, Operations, and other functions to optimize the balance between customer needs and Synthego capabilities.\n* Comfortable operating with uncertainty, the fast-paced and constant evolution of a start-up company, and competitive environments\n* Highly detail-oriented and needed to manage within a regulatory / GMP environment. \n* Strong verbal and written communication and presentation skills\n\n\n\nNice to Haves: \n* 10+ years overall technical sales experience in an FDA regulated market\n* Prior experience with GMP products and / or working knowledge of regulatory requirements of API in US and EU (i.e. ICH Q7).\n* Previous experience working as a bench scientist or researcher in cell therapy\n* Hands-on experience with CRISPR or genome engineering / SynBio products/services\n* Advanced degree in a Life Science field\n\n\n\nCompany Perks & Benefits \n* Equity options \n* Medical, dental, and vision benefits\n* 401k Program\n* Paid parental leave\n* Flexible paid time off\n\n\n\n\n$140,000 - $160,000 a yearBase salary listed is dependent on experience. This role includes quarterly commission bonuses.\nThe company does not provide immigration sponsorship for this position.\n\nAbout Us\n \nSynthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.\n\n\nThe company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.\n\n\nBy providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to API, Senior, Marketing and Sales jobs that are similar:\n\n
$55,000 — $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\nRedwood City, CA
👉 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.
\nTo support the continued growth of our clinical development capabilities, MindMed is seeking an experienced Data Manager or Senior Data Manager to oversee outsourced studies and be responsible and accountable for managing all Data Management deliverables at a consistently high standard concerning cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).\n\nAdditionally, the position would involve managing Real-World Data management assets, including anonymized Electronic Health Records, Medical Claims, patient registries, national surveys, and other emerging data types, enabling company scientists to maximize the use of data for a wide range of applications. They will also manage and catalog Clinical data assets, including historical and ongoing clinical trial data.\n\nResponsibilities:\n\n\n* Serve as DM lead managing assigned study project(s) ensuring overall deliverables/timelines and vendor responsibilities are met and providing oversight of CROs, and other vendors\n\n\n\n\n\n* Represent Data Management on cross-functional study teams\n\n* Oversee multiple concurrent studies while participating in special projects or process improvement initiatives\n\n* Translate clinical protocols into electronic case report forms and develop in conjunction with CRO DM the associated data validation specifications (e.g., edit checks, custom functions and reports)\n\n* Work with multiple external data vendors and facilitate importation of multiple data types into MindMed’s database\n\n\n\n\n\n* Facilitate UAT for database builds and migrations to manage any impacts from mid-study updates to the EDC database and other data collection systems\n\n* Perform data reviews for quality issues, identify general data trends and facilitate data review meetings with relevant cross-functional team members\n\n* Develop technical specifications for data management programming and communicate needs to data management and other technology partners.\n\n* Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.\n\n* Participate in Protocol Deviation review meetings and other data cleaning activities.\n\n\n\n\nRequirements:\n\n\n* Bachelor's degree or equivalent\n\n* 3+ years of direct experience in clinical data management within the biotech or pharmaceutical industry\n\n* Proficient in multiple EDC platforms (InForm, RAVE, Oracle Clinical, or similar) and IRT, with strong understanding of database design, database concepts and related processes (database builds, updates, locks, etc.)\n\n* Knowledge of ePRO/eCOA instruments and their use in clinical studies.\n\n* Working knowledge of CDSIC Standards\n\n* Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects\n\n* Knowledge of compliance, privacy, and safety pertinent to real-world data analytics\n\n* Ability to multi-task, work independently, and act with appropriate accountability\n\n* Readily adapt to new environment, technologies, and processes\n\n* Strong teamwork and collaboration skills\n\n* Excellent written and verbal communication skills\n\n\n\n\nDesired Skills:\n\n\n* Experience in data management or analysis using biomedical/patient health data/real world data/clinical data/novel data streams\n\n* Experience with Data hub platform and interfaces\n\n* Experience in manipulating large amounts of data\n\n* Experience working with privateb and sensitive personal information\n\n* Medidata accreditation\n\n* Experience with data visualization tools (eg, TIBCO Spotfire, elluminate, Power Bl, Tableau, SAS JMP etc.)\n\n* Computer programming skills in Python/Pyspark, R, SQL\n\n* Experience with cloud and high-performance computing environments (AWS, GCP)\n\n\n\n\nWorking Conditions and Travel:\n\n\n* This is a 100% remote position with ~10% travel requirement based on business needs\n\n\n\n\nThe starting base pay range for this position is $114,000.00 - $148,520.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.\n\nEmployees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:\n\n\n* 100% paid health benefits including Medical, Dental and Vision for you and your dependents\n\n* 401(k) program with company match and immediate vesting\n\n* Flexible time off\n\n* Generous parental leave and some fun fringe perks!\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 Travel, Cloud and Senior jobs that are similar:\n\n
$60,000 — $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\nDurham, North Carolina, 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 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
👉 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 Research Data Sciences Co Op
\nRole Summary:\n\n\n\nThe Data Sciences team at Dyne Therapeutics is seeking a Co-Op student to participate in research on innovative therapeutics for rare neuromuscular disease. You will apply your computational skills to the engineering and analysis of data in our drug discovery programs. You will apply your skills in machine learning and data engineering on complex multi-omics and preclinical datasets. In partnership with biology and bioinformatics scientists, you will contribute to insights about novel therapeutic mechanisms and their impact on disease. The successful candidate will be collaborative, detail-oriented, enjoy learning new skills and working in a fast-paced environment.\n\nDyne’s Co-Op Program offers students the opportunity to learn and work at a cutting-edge company in the biotech industry. Through the course of the co-op, you will gain a broad understanding of a variety of experimental and bioinformatics research methods in therapeutic discovery and development.\n\nThis role is for a period of 6 months, beginning in July.\n\nThis role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area. \n\n \n\nPrimary Responsibilities Include:\n\n\n\n\n* Implementation of computational methods and data engineering for omics data sets such as Next Generation Sequencing (NGS). \n\n* Evaluation of computational methods for classification of therapeutic R&D data for understanding of patient population and disease biology. \n\n* Management, integration, and visualization of preclinical and translational data.\n\n* Analytical method development with regular communication of progress to the project team and accurate documentation of technical work.\n\n* Presentation of learnings and findings at the end of the Co-Op term\n\n\n\n\n \n\nEducation and Skills Requirements:\n\n\n\n\n* Undergraduate student in a relevant field, such as bioinformatics, cheminformatics, applied mathematics, or computer science or equivalent experience \n\n* Programming experience in R and/or Python; familiarity with code management and notebook IDE such as jupyter \n\n* Experience with statistical and machine learning methods, such as supervised and unsupervised classification\n\n* Interest in working with biological data types, such as biomolecular sequence, transcriptomics and proteomics\n\n* Understanding of relational databases, SQL, json, or other data management structures\n\n* Strong organizational skills and solid written and oral communication \n\n\n\n\n\n\n#LI-Onsite
\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.
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.
Erasca is hiring a Remote Sr Manager Assoc Director Regulatory Affairs
\nPosition Summary: \n\nReporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials. This role requires an independent, self-directed, and highly motivated clinical regulatory professional.\n\nPosition Responsibilities:\n\n\n* Represent regulatory on study and program teams throughout study conduct and product development.\n\n* Prepare and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA)\n\n* Serve as the primary contact with the FDA, and lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.\n\n* Provide oversight of regulatory submissions to assure technical accuracy, compliance, and completeness.\n\n* Provide regulatory support for company compliance initiatives, including SOP development, Veeva and documentation initiatives, etc.\n\n* Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance.\n\n* Keep current on US and OUS regulations that apply to company products and processes.\n\n* May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs Head or Regulatory Affairs program lead\n\n* Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.\n\n\n\n\nPosition Requirements:\n\n\n* Undergraduate degree required; advanced degree preferred.\n\n* 4+ years of experience in pharmaceutical or biotech regulatory affairs including clinical regulatory affairs for oncology products.\n\n* Ability to translate regulatory requirements into practical workable plans.\n\n* Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies.\n\n* Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.\n\n* Ability to build strong relationships with co-workers of various backgrounds and expertise.\n\n* Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.\n\n* Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.\n\n* Strong learning orientation, curiosity, and passion for science and patients.\n\n\n\n\n \n\nThe anticipated salary range for this position is $190,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. \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
$60,000 — $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\nSan Diego, California, 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 Senior Director Associate General Counsel
\n \nCompany Description:\n\nImmunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compounds, batoclimab and IMVT-1402, are novel, fully human, monoclonal antibodies targeting the neonatal Fc receptor (FcRn). Both are optimized as a subcutaneous injection with potential flexibility in dosing and approach and are designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.\n\n \n\nDue to our growth, we are seeking an Associate General Counsel to join the Immunovant legal department, occupying a position of significant responsibility and reporting directly to Immunovant’s Chief Legal Officer. This individual will work cross-functionally and throughout the organization to provide a broad array of legal and compliance support. The attorney will support Immunovant’s development programs and its multiple clinical trials, SEC filings, and provide counsel and guidance on privacy, business development/alliance management and strategic transactions. High-quality performance in this role will contribute meaningfully to Immunovant’s overall success.\n\n \nKey Responsibilities:\n\n\n* Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams\n\n* Coordinate transactional workflows to ensure consistent and efficient delivery of legal support\n\n* Draft and negotiate a broad range of agreements with a particular emphasis on clinical development agreements and related matters\n\n* Serve as a generalist on complex legal and compliance matters for Immunovant, adding legal and business value across all functional areas\n\n* Maintain frequent contact with all functions within the company while managing requests and prioritizing projects\n\n* Develop and present materials on relevant legal and business issues\n\n* Support business development, securities offerings, and other transactions\n\n\n\n\n \nRequirements:\n\n\n* Juris Doctor degree from an ABA-accredited law school and admission to at least one state bar\n\n* 10+ years of relevant experience including biotech/biopharma/pharma experience in an in-house setting and 15+ years of overall legal experience\n\n* Significant transactional experience and exemplary drafting and negotiating skills on a wide range of agreements\n\n* Excellent judgement and ability to asses risks and benefits and convey them in a clear and concise manner\n\n* Strong work ethic and ability to work independently, yet collaboratively, at all levels of the organization with minimal supervision\n\n* Self-motivated, self-starter, and independent\n\n* Excellent productivity, organizational, and time management abilities\n\n* Demonstrated ability to quickly grasp scientific and technical concepts\n\n* Agility and flexibility to handle multiple tasks in a fast-paced, dynamic, biotech environment\n\n* Effectively handle all job office equipment and software (including computer, Microsoft Office, SharePoint, and Slack)\n\n* Outstanding attention to detail and ability to react and respond quickly and effectively\n\n* Ability to exercise initiative and sound judgment and identify opportunities for improvement\n\n* Excellent written and verbal communication skills\n\n* Strong interpersonal skills\n\n* Creative problem solver and ability to think “out of the box”\n\n\n\n\n \nWork Environment:\n\n\n* The position is remote (work from home)\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Travel as required (<5%)\n\n\n\n\n \n\nCompensation is based on a number of 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 $280,000.00 - $300,000.00.\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 React, Microsoft, Senior and Legal jobs that are similar:\n\n
$60,000 — $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
👉 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.
Xilis, Inc. is hiring a Remote Quality Assurance Specialist
\nXilis, Inc is a Duke spinoff founded by Duke professors David Hsu (M.D./Ph.D) and Xiling Shen (Ph.D) in Durham, North Carolina. The company has been developing cutting-edge Patient-Derived Micro-OrganoSpheres (MOS) technology for precision cancer diagnostics and drug development. Xilis’ transformative platform recreates patient-specific tumors in their 3D and environmental complexity at micro-scale ex vivo, allowing ultra-high-throughput, clinically-relevant, and affordable experimental selection of the safest, most effective drugs for each and every patient in a matter of days. The company aims to transform cancer care by ensuring each and every patient gets treated in a timely manner with the single most appropriate drug available to them. We are supported in this mission by top Silicon Valley and New York venture firms that are leaders in the healthcare space and have invested in top precision medicine companies including Foundation Medicine and Guardant Health. \n\n\nRole\n Xilis is looking to hire a Sr. Quality Assurance Specialist to support the further development of the Quality & Compliance programs. This hands-on individual partners across functions to develop and support program development, integration, implementation, and process improvement activities. The primary responsibilities of this position will be to consult with department representatives, project teams, and management to ensure compliance of deliverables and products. As part of the Quality & Compliance team, you will be responsible for developing, maintaining, and executing procedures, overseeing operations, and providing consultation on the implementation of Quality & Compliance programs. \n\n\n\nResponsibilities\n* General administration of company policies and procedures.\n* Ensures that the organization operates within established policies/procedures and complies with applicable governmental regulations (GMP, CLIA, EMA, etc.)\n* Assist in the development and execution of the quality schedule \n* Develops, maintains, and provides expertise on site quality and/or business systems, tools, data, procedures, and processes on an ongoing basis\n* Work directly with Xilis teams to provide process oversight and to support them in their efforts to comply with company standards and regulatory requirements\n* Provide expertise and guidance with the interpretation of policies, regulatory requirements, and / or internal processes\n* Schedule, plan, conduct, and document internal and supplier audits\n* Supports regulatory and customer audit/inspection readiness of the organization; review audit outcomes to ensure appropriate and timely corrective actions are implemented (as applicable)\n* Supports the compilation, analysis, and reporting of metrics, including identification of trends and/or root cause to help develop and deploy new initiatives and process improvements\n* Uses existing procedures to solve routine or standard problems and uses data to make Quality decisions. Where procedures may not exist, identify compliant solutions and / or develop appropriate procedures.\n* Create and maintain risk assessments to ensure program / project risks are identified, assessed, mitigated, and closed.\n* Conducts Quality-focused training sessions to educate team members; training may include aseptic practices, deviations investigations, data integrity, quality risk management, and change management.\n* Performs quality reviews of technical documents to assure the accuracy, completeness, and clarity of the documents and ensure that documents meet relevant requirements\n* Manages, tracks, and reports status of Quality Systems programs including Deviation Management, Corrective Action and Preventive Action (CAPA), Change Control, and Quality Risk Management.\n* Support validation activities by creating, contributing, reviewing, and / or approving associated deliverables\n\n\n\nRequirements\n* 5+ years of experience working in the biotech or pharmaceutical industry; preferably with CLIA experience\n* Experience leading deviation investigations through to root cause and CAPA development\n* Prior auditing experience in a regulated environment\n* Strong interpersonal communication and time management skills\n* Strong written and oral communication skills with the ability to convey information in a clear and concise manner to entry-level staff and executive management\n* Highly effective team and interpersonal skills, including the ability to work across scientific disciplines\n* Excellent organizational skills and attention to detail\n* A flexible attitude with respect to work assignments, tight timelines, and new learning opportunities\n* Participation in the development of department goals, objectives, and key performance indicators\n* Exceptional analytical and problem-solving skills with the proven ability to think strategically\n\n\n\n\n\nXilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!\nXilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!).
\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\nDurham, NC
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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.
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.
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