Post job

RQM jobs - 30 jobs

  • RQM+ General Application Form

    RQM 3.7company rating

    Remote RQM job

    RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better. We don't make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency We are always interested in speaking to expert personnel with backgrounds in either Regulatory Affairs, Quality Assurance, Clinical Trials, Auditing, Medical Writing and Laboratory services.Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity VerificationAt RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.
    $36k-58k yearly est. Auto-Apply 60d+ ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Senior Chemist I

    RQM 3.7company rating

    RQM job in Mansfield, MA

    Job Description RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better. We don't make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency. Job Summary: The Senior Chemist I is designed for an experienced, independent chemist and will perform laboratory analyses and support scientific data interpretation. This role will be responsible for conducting a variety of analyses, interpreting data, and developing technical reports for customer projects. The Senior Chemist I will leverage strong scientific knowledge and experience to ensure accurate and efficient testing while maintaining a focus on meeting client and internal standards. This role requires the ability to work autonomously with minimal supervision, while still collaborating effectively with laboratory teams and other departments to meet project goals. Primary Responsibilities: Perform laboratory experiments to develop, optimize, and validate analytical methods (HPLC, GC, LCMS, GCMS). Prepare and analyze samples for routine testing, stability studies, and in-process controls, ensuring accuracy and reproducibility. Operate, calibrate, and maintain analytical instruments (e.g., HPLC, GC, LCMS, GCMS) and troubleshoot issues to minimize downtime. Support advanced analysis and writing of challenging, complex customer projects and related business needs. Collaborate with Laboratory Chemists, Study Directors, and Research & Development teams to ensure alignment with project goals and timelines. Review and assess data for trends and discrepancies and suggest improvements where applicable. Ensure compliance with regulatory guidelines, laboratory safety protocols, and best practices during all laboratory activities. Maintain thorough documentation of experimental procedures, results, and data interpretations. Contribute to the development of laboratory methods and procedures. Provide technical support and mentorship to junior team members as needed. Act as support on primary review report writing process and finalization. Champion laboratory safety protocols, regulatory compliance, and adherence to industry best practices, continuously evaluating and improving safety measures in the lab. Keep up to date with the latest scientific literature, emerging technologies, and industry innovations, ensuring that the laboratory maintains a competitive edge in scientific advancements. Any other duties and tasks as directed by the supervisor. Requirements: Bachelor's Degree in relevant field with 7+ years' experience; Masters 3+ years' experience; Ph.D. 0-2 years' experience. Proficiency in performing and interpreting laboratory experiments using techniques such as HPLC, GC, LCMS, GCMS. Advanced knowledge and understanding of analytical method development. Advanced knowledge and understanding of scientific report writing. Advanced knowledge and understanding of investigative and regulatory techniques. Advanced practitioner of all scientific methods and troubleshooting. Advanced practitioner of all software with a deep understanding of settings and features. Ability to be innovative and use the software to solve problems. Ability to perform well under pressure and work with minimum supervision. Demonstrate the ability to perform work accurately and efficiently Computer proficiency and experience with all MS products Computer skills proficiency and ability to learn new software. Detail-oriented self-starter with ability to manage multiple projects, work independently, and learn new disciplines. Excellent verbal and written communication skills. Demonstrates the drive and energy to be effective. Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning Supervisory Responsibilities: This position will have no supervisory responsibilities. Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds. Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information.
    $101k-132k yearly est. 5d ago
  • Sr. Account Manager, Skeletal Conditions (Chicago)

    Biomarin Pharmaceutical 4.6company rating

    Remote job

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Commercial Our Commercial organization leads our global sales and marketing strategies around the world. Our integrated team continues to solidify BioMarin's commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. SUMMARYThis position requires performance driven individuals with strategic problem- solving skills, high business acumen that can work collaboratively with multiple stakeholders. The ideal candidate will have sales experience in pediatric endocrinology clinics and/or comparable experience in rare disease. Experience launching a first in class therapy and building new therapeutic markets desired. The Account Manager must maintain a high level of knowledge within the disease states, product labeling. The primary call target is pediatric endocrinology, pediatric orthopedics, and genetics located both in Institutions and office-based setting. Targeted pediatricians with ACH patients will also be key call points in filling the funnel. Activities include disease state and product education to referring HCPs, office readiness for patient starting therapy as well as coordination of multiple departments/stakeholders and BioMarin's field based clinical support team. Skills required include account management, organizational, analytical, and problem-solving. Individuals must be flexible, and adaptable with sensitivity to the potential constraints of a commercial start-up. Must be goal oriented and accountable for their individual performance, while acting in a professional and compliant manner. Cold calling on all targeted specialties is a requirement. RESPONSIBILITES:The Account Manager will be responsible for: Achieving area sales objectives, market penetration, new patient starts, and revenue targets on a quarterly & annual basis Driving demand through clinical selling and education to referring and treating health care providers focusing on skeletal conditions. This includes cold calling on key accounts as needed for access. Implementing an effective business plan to guide strategy, tactics and track progress Developing and maintaining excellent working relationships with all key stakeholders including Pediatric Endocrinology, Pediatric Orthopedics, Genetics, and key referring physicians that could include Pediatrics Actively participating in disease awareness efforts and burden/natural history of disease through professional society meetings (local, state, regional), as assigned. Working with other members of the Skeletal Conditions Brand team, and facilitating appropriate collaboration with other functions, such as MSLs, Market Access team, Compliance, and other internal stakeholders, as needed Becoming an expert in the clinical data and verbalizing its significance to all stakeholders Proactively providing business insights to internal partners as to the clinical practices of assigned accounts Acting in compliance within a highly regulated industry and consistent with training, policies, guidelines, and their own best judgment while adhering to all company policies assigned to the Account Manager position Ability to work with ambiguity and remain agile as organization needs evolve SCOPE: Must be able to work some evenings and weekends, as needed, for educational events (both in person and virtual) Depending on geography, must have the ability to manage a multi-state territory with diverse customer base Overnight travel is required and will range from 40%- 60% depending on the geography and business needs of the individual territory Advanced virtual skillset required to balance travel demands with opportunities to meet healthcare providers and/or caregivers virtually. REQUIREMENTS: Bachelor's degree required PREFERRED EXPERIENCE: At least 5 years of sales experience in biotech/rare disease involving specialty products that are technically challenging and first in class Experience with office-based selling in complex model of referral health care providers to prescriber health care providers in newly created market Experience working in a field team model with field based clinical support and reimbursement hub model Pediatric Endocrinology, Genetics and/or Pediatric Orthopedics strongly preferred Experience in new product launches and preferably with first in class product Experience in a role that works directly with patients/families. Experience and committed to long sales cycle to ensure medical home is created The territory will include: Chicago, IL, Madison and Milwaukee, WI and surrounding areas. This is a remote position. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
    $107k-135k yearly est. Auto-Apply 36d ago
  • Senior Executive Assistant

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    Senior Executive Assistant to the COO The Senior Executive Assistant provides high-level, strategic administrative support to the Chief Operating Officer (COO) and plays a critical role in supporting the broader Research & Development (R&D) and Operations organizations. This position is essential to optimizing executive effectiveness, managing complex priorities, and ensuring seamless coordination across senior leadership, cross-functional teams, and external stakeholders. The ideal candidate is proactive, highly organized, discreet, and thrives in a fast-paced, dynamic environment. Key Responsibilities Provide comprehensive executive administrative support to the COO, enabling focus on strategic priorities and operational excellence Support the broader R&D and Operations leadership teams through coordination, scheduling, and administrative partnership as needed Optimize executive workflows and proactively streamline schedules for maximum efficiency and impact Manage highly dynamic calendars, serving as a trusted gatekeeper while balancing business priorities, sensitive matters, and urgent requests Anticipate executive needs and proactively resolve scheduling conflicts and last-minute changes with professionalism and discretion Prepare, coordinate, and support internal and external meetings, ensuring leaders are well-prepared and debriefed to maximize effectiveness Partner closely with senior leaders and cross-functional stakeholders across R&D and Operations to facilitate communication and alignment Plan and manage complex travel arrangements (domestic and international; commercial and private) and manage expense reporting Maintain a strong understanding of business context, operational priorities, and R&D initiatives to provide informed, strategic support Serve as a trusted liaison on behalf of the COO and leadership team, cultivating strong relationships across the organization Collaborate with the broader Executive Assistant team on special projects, strategic initiatives, and coverage as needed Assist with planning and execution of team and/or company events, executive offsites, and leadership retreats Handle highly confidential information with the utmost discretion and integrity Required Qualifications 5+ years of experience supporting C-level or senior executives, preferably within technology, manufacturing, or life sciences industries Exceptional time management, organizational, and prioritization skills Strong interpersonal skills with the ability to build trust and credibility at all levels, including senior leadership and cross-functional partners Excellent verbal and written communication skills Proven ability to manage multiple priorities and projects simultaneously in a fast-paced environment Demonstrated problem-solving skills and sound judgment, with the ability to escalate issues appropriately High attention to detail and commitment to accuracy Ability to work independently with minimal supervision while remaining highly responsive; works with urgency Resilient, adaptable, and willing to step in where needed to support team and business needs Experience with expense management, complex travel coordination, and presentation development Demonstrated track record of professional success and a positive, can-do attitude Preferred Experience Bachelor's degree or equivalent experience, preferred Experience supporting complex organizations such as R&D, Operations, Engineering, or Manufacturing, preferred Prior experience working with senior leadership teams and cross-functional stakeholders, strongly preferred Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: $128,800.00 - $193,200.00 To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $54k-75k yearly est. Auto-Apply 5d ago
  • Contractor - Talent Acquisition Coordinator

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    Temporary Assignment: Contractor - Talent Acquisition Coordinator Pay Rate: $25-$30 per hour Estimated Duration: 12 months What you get to do daily In this role, you will interact directly with executive management, hiring managers, candidates, and outside vendors. The Talent Acquisition Coordinator will collaborate cross-functionally with various departments across the entire PacBio global organization. You will contribute to the overall success of PacBio by aggressively driving the recruiting process, producing quality output, with a high level of professionalism. Keys to your success in this role Your ability to thrive in a fast-paced, rapidly changing environment. You are meticulous with attention to details. You are a self-starter. You approach your work with a sense of ownership. Your ability to create exceptional experiences for candidates and hiring teams. What's in it for you You will get to be part of a team of curious, action oriented, customer focused, professionals who care deeply about each other. Our mission is to enable the promise of genomics to better human health. Responsibilities: Scheduling: High-volume scheduling of phone, video, and in-person interviews. Reserving conference rooms and coordinating meetings. Travel: Organize travel arrangements for candidates - flights, car rental, and hotel accommodations. Process candidate travel expenses. Greet and assist candidates to ensure positive onsite interview experiences. Documentation of processes as needed. Identify opportunities for improving hiring manager and candidate experiences and scheduling efficiency; make process recommendations to achieve operational excellence. Identify and troubleshoot issues and escalate as appropriate. Required Qualifications: High School diploma or equivalent. Proficient in MS Outlook, Word, and Excel. Ability to work in a fast-paced, high-volume scheduling environment. Strong attention to detail and accuracy; excellent follow-through skills. Must have strong initiative and the ability to work independently. Ability to effectively partner and collaborate with peers to deliver positive candidate and hiring manager experiences. Strong organizational and prioritization skills, ability to balance several priorities from multiple sources, flexibility and adaptability in dealing with rapidly changing priorities and demands. Ability to exercise sound judgment with the ability to recognize and handle sensitive/confidential information. Outstanding customer service skills. Excellent interpersonal, written, and verbal communication skills. Preferred Experience: Experience with Workday Recruiting is a plus. Experience as a talent acquisition coordinator or administrative assistant, preferred. Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $25-30 hourly Auto-Apply 9d ago
  • Therapeutic Specialist, Seattle North

    Insmed, Inc. 4.9company rating

    Remote or Seattle, WA job

    At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for a Therapeutic Specialist, Seattle North & Alaska on the Commercial team to help us expand what's possible for patients with serious diseases. Reporting to the Regional Director, you'll in this role, you will develop, lead, and execute a sales plan with specific goals and targets to maximize sales growth in the current rare disease market. What You'll Do: In this role, you'll have the opportunity to : * Maintain exceptional knowledge of: disease state, product, customer, orphan/rare and specialty drug market, competitive landscape and the broader healthcare market place. * Demonstrate high performance driven by common values of trust, respect, and commitment to winning the right way (culture of compliance). * Foster an entrepreneurial spirit with a focus on ownership to maximize individual and company goals, establishes open and honest communication with peers and leadership. * Collaborate with cross functional partners (Market Access, Patient Support) to achieve shared business objectives in a compliant manner. * Identify and establish appropriate business relationships with emerging thought leaders and customers; demonstrated ability to recognize and devote the necessary amount of time and resources needed to engage with HCPs. * Demonstrate expert knowledge of Insmed products & disease states, customer base (HCP), business strategy and competitive environment; stay abreast of key market access issues/trends. * Perform all company business in accordance with all regulations and company policy and procedures. * Demonstrate high ethical and performance standards with all business contacts in order to maintain Insmed's exceptional reputation. Who You Are: You have a bachelor's degree with a minimum of 3 years of biotech/pharma product promotion. You are or you also have: * Experience successfully launching biotech/pharma products with a proven track record of success in exceeding goals. * Portfolio selling experience preferred. * Specialty disease experience &/or rare-orphan experience preferred. * Strong business partnerships in the Pulmonary and/or Infectious Disease community desired. * Preferred experience working compliantly in patient support models. * Strong analytical skills with the proven ability to effectively analyze data to appropriately integrate into strategic planning. * Demonstrated business acumen and a track record of accountability in exceeding territory results. * Customer relationships, interpersonal and communication skills with the established ability to effectively work with diverse audiences and influence cross functionally. * High learning agility and scientific acumen * Must have excellent communication skills (verbal and written) Where you'll Work This is a fully remote role, field based position. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Travel: This position involves frequent travel (up to 30%) for depending on the size of the geography. #LI-JTI #LI-Remote Pay Range: $155,000.00-201,500.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: * Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) * Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration * 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance * Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities * Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at *********************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
    $44k-62k yearly est. Auto-Apply 30d ago
  • Staff Engineer, Software, Test

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health. We are now entering the century of biology and genomics is at the heart of the next revolution. Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team. Position Summary: As a Staff Software Engineer in Test at PacBio, you will play a crucial role in ensuring the quality and reliability of software applications integral to our genomic sequencing platforms. You will collaborate closely with software developers, product managers, and bioinformatics scientists to develop and execute comprehensive test plans leveraging test automation as well as white box and black box testing. Your contributions will directly impact the accuracy and efficiency of our cutting-edge sequencing systems, empowering scientists and researchers worldwide. Responsibilities: Develop and enhance test automation and tools for multiple DNA sequencer instrument control systems as part of development and release cycles. Develop and implement test plans, test cases, and test scripts to validate software functionality, performance, and usability leveraging automated testing, white box and black box approaches. Conduct thorough testing of software applications, including functional, regression, integration, and system testing. Identify, document, and track software defects and work closely with development teams to resolve issues. Collaborate with cross-functional teams to ensure alignment on quality standards and requirements. Participate in design and code reviews to provide input on potential issues and improvements from a quality perspective. Contribute to the continuous improvement of QA processes and methodologies. Stay updated on industry best practices and emerging technologies relevant to software quality assurance in life sciences. Required Qualifications: Typically requires a minimum of 7-10 years of related experience with a Bachelor's degree; or a minimum of 5-8 years with a Master's degree; or a minimum of 3-7 years with a PhD. A degree in Computer Science, Biotechnology, Bioinformatics, or a related field. Experience with test automation for robotics, device control and simulation of hardware devices. Experience with the entire test cycle - from test design and authoring to execution, debugging and log analysis, as well as reporting. Experience with automated testing tools and test frameworks (e.g., pytest). Fluency with one or more scripting languages (i.e., Python, JavaScript). Experience with test automation for robotics, device control and simulation of hardware devices. Proven experience in software quality assurance, preferably in a regulated industry such as biotechnology or healthcare. Ability to work effectively in a collaborative team environment and communicate complex technical issues clearly and concisely. Strong analytical and problem-solving skills with a keen attention to detail. Excellent interpersonal, written, and verbal communication skills. Preferred Experience: Knowledge of regulatory requirements (e.g., FDA, ISO) for software development in healthcare or life sciences. Experience with genomic data analysis or bioinformatics tools is a bonus. Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: $170,400.00 - $255,600.00 To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $170.4k-255.6k yearly Auto-Apply 60d+ ago
  • Associate Director, Medical Science Liaison - HS - Northeast

    Insmed, Inc. 4.9company rating

    Remote or New York, NY job

    At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for an Associate Director, Medical Science Liaison on the US Medical Affairs team to help us expand what's possible for patients with serious diseases. Reporting to the National Sr Director, US Field Medical you'll develop and maintain professional relationships with external healthcare practitioners to provide comprehensive medical and scientific support for the therapeutic area of Hidradenitis Suppurativa (HS). Northeast Territory - MA, DE, NJ, PA, NY, CT, RI, NH, VT, ME What You'll Do: In this role, you'll have the opportunity to provide medical and scientific support for HS. You'll also: * Engage appropriately in scientific exchanges around product information, disease education, and research ideas/activities with physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Insmed * Work closely with Insmed personnel to ensure adequate training, access to educational resources and alignment between Insmed's medical affairs plans and the unmet needs of the patients and healthcare professionals * Work cross-functionally with Commercial colleagues (Key Account Directors and Sales) to coordinate proper response to customer's scientific and medical needs * Maintain annual expenses within assigned budget parameters * Accurate and timely documentation of all activities * Identify Medical Experts, consultants, investigators, and healthcare professionals (HCP) in assigned therapeutic areas. Ensure timely, effective, and appropriate communication of current and emerging medical and scientific information on Insmed therapeutic disease areas and/or product support of appropriate prescribing, improved patient outcomes * Present data on Insmed products to HCPs including physicians, academic institutions, researchers, and allied health care professionals, consistent with all Insmed policies and procedures * Implement Advisory Board and other scientific forums to bring back critical customer insights and feedback * Conduct scientific exchanges related to Insmed's products at Centers of Excellence and Academic Medical Centers. Ensure that healthcare organizations have the latest information on Insmed disease state and/or products resulting in appropriate prescribing and improved patient outcomes * Field therapeutic area expert demonstrating high scientific knowledge and competency of Insmed therapeutic disease states, products, and competitor data. Serve as a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Bring together, synthesize and deliver HCP derived scientific insights to Insmed * Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing recruitment motivation, and issue/problem solving * Provide medical and scientific support to payers, commercial managed markets, and related health care organizations to facilitate access to Insmed's medications for appropriate patients. Demonstrate strong competency in medical and scientific exchange to healthcare organizations * Deliver and implement effective product and disease-state training and mentoring to internal Insmed colleagues * Identify, develop, and maintain credible relationships with key medical, pharmacy, and health outcomes influencers within the territory for assigned National and Regional accounts * Provide timely, fair balanced, objective, scientific and evidence-based medical information, and education to health care customers within managed markets/healthcare/payor systems, in addition to other unique healthcare influencers * Full support and execution of Medical Affairs plans, Clinical Development projects, programs, and initiatives. Who You Are: You have an Advanced degree (MD, PharmD, PhD) or medical certification (PA/NP/RN) along with 5 years of MSL or related experience. You are or you also have: * Hidradenitis Suppurativa (HS) and/or Dermatology experience * Effective communication and presentation skills and advanced proficiency in interpersonal skills (listening, probing, persuasiveness, negotiation) for engaging successfully and productively with HCPs, external customers, field colleagues, and internal partners * Skilled in conflict resolution and problem solving * Knowledge of the PhRMA code of conduct, the Sunshine Act, HIPAA regulations, Promotional Regulations, and all laws and regulations that are applicable to the role * Steadfast ethical standard and conduct * Ability to understand and dialogue on subjects that are at the interface between medicine and policy which are relevant to Insmed's areas of interest (disease condition, patient reported outcomes, competitive pipelines and lifecycle plans, medical and pharmacy benefits, quality programs, etc.). * Committed to self-improvement Nice to have (but not required): * Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/trial experience and 2 years clinical or research experience (non-pharma) Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This position involves frequent domestic travel - Up to 80%; some of which will be overnight in nature #LI-REMOTE #LI-MC1 Pay Range: $187,000.00-244,000.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: * Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) * Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration * 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance * Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities * Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at *********************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
    $187k-244k yearly Auto-Apply 2d ago
  • Ex-FDA Inspector

    RQM 3.7company rating

    Remote RQM job

    RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better. We don't make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency To help support our ever growing and expanding Global Audit Practice, we're interested in speaking to Ex-FDA Inspectors who would be interested in supporting RQM on various FDA mock audits on a contract basis for our clients in the EU and U.S. These will be a mixture of on-site and remote desktop audits.Primary Responsibilities: The candidate will have previously worked as a Medical Device Inspector for the US Food & Drug Administration (FDA), within the past 10 years (2015-2025) and with a minimum of 5 years' experience as an Inspector The candidate will be expected to travel globally to conduct onsite audits The candidate will work with the RQM+ project team to coordinate the audit schedule The candidate will work with the RQM+ project team to support the audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report The candidate will be capable of providing the clients with 80% auditor (hats on) and 20% mentor (hats off) The candidate will be responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back to the RQM+ project team The candidate will be responsible for maintaining their training in new / revised regulations, standards and guidance's as they become available This is a client facing role and the candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits As an auditor there will be challenging situations and difficult conversations with the client When appropriate the candidate will escalate the challenging situation to the RQM+ project team The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right Requirements: A former US FDA Medical Device Inspector (within the past 10 years, 2015-2025) with a minimum of 5 years' experience as an FDA Inspector Expertise in Quality System Inspection Technique (QSIT) Expertise in ISO13485:2016, MDSAP audit techniques highly desirable Expertise in EU MDR / EU IVDR audit techniques an advantage Robust auditing experience Communicate effectively and proactively A university degree or equivalent in science or nursing Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity VerificationAt RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.
    $39k-49k yearly est. Auto-Apply 60d+ ago
  • Therapy Access Manager (TX/AR/LA/MS)

    United Therapeutics Corporation 4.8company rating

    Remote job

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You are an empathetic person with a strong work ethic who enjoys supporting HCP's streamline processes to improve patient access to UT therapies. You are eager to collaborate with cross-functional teams, including UT Cares partners, Market Access, Specialty Pharmacies, and commercial teams, to develop and implement plans that optimize patient access and reimbursement. You are an expert in patient access with an understanding of essential things like provider engagement, specialty pharmacies, patient services offerings, and the referral process. You want to work in an environment that is collaborative and innovative where you can showcase your expertise. The Therapy Access Manager (TAM) is a customer-facing role that will be responsible for managing defined accounts within a specific region or territory, to support access for providers and patients. The role will provide education to healthcare providers and office staff on access services and reimbursement solutions specific to United Therapeutics' products. The TAM will demonstrate a compliant and consultative approach providing education to offices related to insurance authorization and/or reimbursement of products for appropriate patients. Manage defined accounts within a specific region or territory, to support access for providers and patients including providing education to healthcare providers and office staff on access services and reimbursement solutions specific to United Therapeutics' products. Execute a region or territory strategic plan through partnership with internal and external stakeholders, which may include call center / HUB services, market access, and/or other matrix field partners. Serve as the payer expert for a defined geography and communicate payer changes to key stakeholders in a timely manner. Ensure understanding of the reimbursement process, specialty pharmacies, field reimbursement services, and UT's patient support program. Advise on patient level reimbursement issues in compliance with policies and well-defined Rules of Engagement. Abide in a compliant manner and work closely within a defined set of Rules of Engagement Manage daily activities that support appropriate patient access to United Therapeutics' products in the provider offices and work as a liaison to other patient assistance and access support services offered by United Therapeutics Compliantly serve and support customers as an extension of patient support as appropriate, and provide in-person customer visits Participate in cross-matrix meetings as appropriate. Participate in regularly scheduled team meetings and calls. Input call activity into customer relationship management tool (CRM). Provide office education and awareness during the entire access process which may include formulary coverage/utilization management criteria, insurance forms & procedures, benefits investigation, prior authorization, appeal, and/or claims resolution Educate physician office staff on the use of patient support services using UT approved educational materials, including web-based provider portals and other tools/resources as available Territory to include: Southern half of TX, LA, AR and MS. Minimum Requirements Bachelor's Degree 6+ years of relevant industry experience 1+ years of experience in Market Access and Field Reimbursement supporting specialty products Experience with specialty/biologic products and/or complex reimbursement process Experience educating HCPs on client specific patient service programs (i.e. copay, nurse education, patient assistance, etc.) Ability to manage ambiguity & problem solve Solution oriented mindset, strong business acumen, & strong analytic capabilities Ability to manage greater than 50% travel Ability to prepare and submit appropriate expense reports in a timely manner Preferred Qualifications Experience in the therapeutic area of cardiology or pulmonology Rare & Orphan drug experience Demonstrated ability to educate offices on access processes and issue resolution Experience delivering educational presentations in person and/or via technology platforms such as Zoom, Webex, and/or Teams Advanced knowledge of medical insurance terminology Knowledge of Centers of Medicare & Medicaid Services (CMS) policies and processes with expertise in Medicare (Part B and Part D) Job Location This position will require candidates to live within the assigned territory. This includes the southern half of TX, LA, AR and MS. The salary range for this position is $150,000 - $195,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************* At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $150k-195k yearly Auto-Apply 47d ago
  • Regional Nurse Specialist (Boston/New York)

    United Therapeutics Corporation 4.8company rating

    Remote job

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You are a proactive, self-starter who loves to teach. You are excited to offer resources to support prescribers, nurses and other allied healthcare professionals new to UT product(s) with all aspects of the product to include indications, dosing and adverse effect management; provide practical guidance on appropriate product administration techniques and patient follow-up based on good clinical practice. You want to work through HCPs to support new patient therapeutic initiation and the referral process, helping to ensure that prescribers have the tools and education necessary to successfully and safely start patients on UT products. You are ultimately looking to work for a company that is innovative and inspiring where you can truly make a difference. Territory to include: ME, VT, CT, MA, RI, NH and Upstate NY Minimum Requirements Bachelor's Degree in Nursing 5+ years of experience working in cardiology or pulmonology and/or relevant nurse educator experience Strong teaching and presentation skills Ability to work as part of a larger team Strong interpersonal and communication skills Proficient in Microsoft Excel, PowerPoint, Word, and Outlook Ability to work with minimal supervision DL NUMBER - Driver License, Valid and in State Ability to travel a minimum of 80%, including overnight travel Preferred Qualifications 1+ PAH Coordinator or PAH Clinical Practice experience RN - Registered Nurse - State Licensure and/or Compact State Licensure (active in at least one state, multi-state preferred) Project management skills Multi-Lingual Job Location This position will require candidates to live within the assigned territory. This includes ME, VT, CT, MA, RI, NH and Upstate NY. The salary for this position ranges from $114,000 to $145,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $48k-64k yearly est. Auto-Apply 10d ago
  • Director, Cold Chain Management & GDP Compliance

    Biomarin Pharmaceutical 4.6company rating

    Remote job

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Director Cold Chain Management & GDP Compliance Fully remote role, US Candidates SUMMARY DESCRIPTION The Director, Cold Chain Management & Supply Chain GDP is a key role as part of the Global Distribution organization. This role is critical to ensuring the integrity of temperature-sensitive pharmaceutical products throughout the supply chain, while maintaining full compliance with Good Distribution Practice (GDP) regulations and internal quality standards. The incumbent will lead the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of all clinical and commercial materials in BioMarin. RESPONSIBILITIES Cold Chain Engineering · Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products. Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities. Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets. Drive innovation in cold chain technologies and the streamlined management and quality of associated data. Supply Chain Compliance & GDP Ensure global compliance with GDP regulations and internal quality standards across all distribution channels. Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity. Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations. Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps. Leadership & Strategy Direct management of a team of individual contributors across global regions Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities. Advise senior leadership on investment decisions and emerging trends, providing timely risk insights and strategic recommendations that support informed decision-making. SCOPE This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes: · A firm commitment to BioMarin's cultural beliefs and values · Consistent track record of exceeding objectives within area of influence· Ability to achieve results through others without direct reporting lines· Strong problem-solving skills with a global focus both internally and externally· Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry · Flexibility and ability to deal with changing priorities without losing sight of the overall business· Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change · Proactive and energetic outlook with an unwillingness to accept the status quo· Interaction and collaboration with team members, peers and senior management· Ability to work independently with strong time management skills EDUCATION Bachelor's or Master's degree in Engineering, Supply Chain, Life Sciences, or related field. 10+ years of experience in pharmaceutical supply chain, with significant expertise in cold chain and GDP compliance. Proven leadership experience in a global, matrixed organization. Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.). Excellent communication, stakeholder management, and problem-solving skills. Preferred Qualifications: Experience with biologics, vaccines, or advanced therapies. Familiarity with digital monitoring systems and data analytics in cold chain. Lean Six Sigma or similar process improvement certification. EXPERIENCE · Bachelor's degree in related curriculum with a minimum of 10-12 years of experience in global trade compliance · Previous experience leading a global team · Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes). · Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions to make the company's Trade Compliance stronger and more efficient. · Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk · Ability to effectively work autonomously and independently Circa 15% travel CONTACTS Commercial, Site Operations, Clinical Supply Chain Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, FinanceExternal partners including 3PL providers, transport carriers. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
    $115k-144k yearly est. Auto-Apply 52d ago
  • Cardiopulmonary Sales Specialist - PAH (Minneapolis) *Rare Disease Sales Opportunity*

    United Therapeutics Corporation 4.8company rating

    Remote job

    California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension( PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are Are you ready to make a real impact in patients' lives? Come join our passionate sales team, which is dedicated to supporting those who rely on our life-changing therapies to fight pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease (PAH and PH-ILD). You will be the key player in maintaining and increasing sales of United Therapeutic products by relying on your keen ability to engage and educate healthcare professionals. We seek patient-focused individuals who are driven to succeed and passionate about making a difference. Promote marketed products according to corporate guidance in an assigned geographic territory and designated accounts to actively interface with the PAH and/or PH-ILD community Build and maintain professional relationships with various customer types to ensure maximal product messaging and education Analyze sales reports and develop and implement business plans to increase business and drive sales in key accounts, achieving or exceeding target sales goals Coordinate activities with other field-based team members to optimize selling, education, and support efforts Develop and maintain expert knowledge of disease state, product, and competitive landscape Attend local/regional/national medical PAH and/or PH-ILD symposia and conferences in order to provide educational and promotional support to key stakeholders Attend patient support group meetings and remain current with PAH and/or PH-ILD community in accordance with our PHA's guidelines Participate in project teams with sales and marketing teams to establish programs and resources to increase sales and awareness Minimum Requirements Bachelor's Degree At least 6 years of experience successfully selling pharmaceutical therapies or similar products to physicians, nurses, and other health care professionals AND at least 2 years of selling to specialty physicians (cardiologists, pulmonologists, etc.) OR at least 6 years of healthcare/nursing experience with advanced lung disease Experience in Cardiovascular and/or Pulmonary Disease therapeutic area Proven success in business development, account management, and territory planning. Strong clinical acumen Valid Driver's License in good standing Preferred Qualifications Experience selling within institutional or major teaching centers environment Job Location and Travel This territory covers the greater MSP, North Dakota, South Dakota and the surrounding perimeter, including a portion of Wisconsin. Overnight travel may be required. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. The salary for this position ranges from $130,000 to $160,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************* Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $130k-160k yearly Auto-Apply 6d ago
  • Business Development Professional- All Levels

    RQM 3.7company rating

    Remote RQM job

    RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better. We don't make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency The Business Development Team at RQM+is responsible for driving sales growth through the integrated sale of services-Regulatory, Quality, Clinical Trials, and Lab (Biocompatibility and E&L)-positioning RQM+ as The MedTech CRO and trusted partner across the product lifecycle. This role works closely with cross-functional experts and client stakeholders to uncover needs, shape solutions, and close strategic opportunities that align with our value proposition. Responsibilities: Develop and execute account plans focused on expanding RQM+'s footprint across all service lines. Lead consultative sales efforts by understanding customer goals across innovation, market access, compliance, and lifecycle management. Effectively position the value of RQM+'s integrated solutions-including Regulatory, Quality, Clinical Trials, and Lab testing-to decision-makers and influencers. Build and manage a robust pipeline of qualified opportunities from early engagement through contract. Conduct targeted outreach, client meetings, and proposal development to drive pipeline progression. Build and maintain trusted, long-term working relationships with both existing and potential clients. Serve as the primary point of contact for client needs, concerns, and requests, ensuring high levels of responsiveness and service quality. Collaborate with internal stakeholders, including Project Leaders, finance, and marketing-to develop solutions and prepare proposals, estimates, and contracts. Respond promptly to new client inquiries, ensuring initial qualification and follow-up within 24 hours. Regularly assess client satisfaction, share industry insights, and identify areas for growth and improvement. Maintain accurate opportunity and activity data in Salesforce and other RQM+ CRM tools to support forecasting and reporting. Contribute to team success by supporting peers and sharing best practices. Stay current on industry trends, regulatory developments, and product offerings to better serve client needs. Requirements: Bachelor's degree in a relevant field required. Minimum of 3 years of experience in a Contract Research Organizationselling clinical trials to medical device clients, required. Experience in biotech/pharma will also be considered. Proficiency in Salesforce and sales productivity tools. Experience reviewing or developing sales contracts,preferred. Ability to manage multiple client relationships while consistently exceeding sales targets. Strong track record of achieving and exceeding sales targets. Excellent communication, negotiation, and relationship-building skills. Ability to identify and act on new business opportunities with a solution-oriented approach. Strong organizational skills and the ability to manage multiple accounts simultaneously. Proactive and results-driven with a customer-first mindset. Behaviors: Resilience & Persistence, Problem Solver, Intellectual Curiosity, Drive & Initiative, Results Driven, Reliability, Organized, Initiative, Accountability, Interpersonal Savvy, Strategic Seller, Sales Judgment & Collaboration Supervisory Responsibilities: This position does not have supervisory responsibilities. Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity VerificationAt RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.
    $48k-76k yearly est. Auto-Apply 60d+ ago
  • Scientist II, Bioinformatics

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health. We are now entering the century of biology and genomics is at the heart of the next revolution. Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team. We are seeking a computational scientist to develop and apply long-read sequencing methods in cancer research and human genomics. In this role, you will build software that enables streamlined analysis of PacBio HiFi data, including secondary analysis tools and production pipelines; run large-scale genomic workflows; and interpret results from diverse datasets. You will collaborate closely with internal teams and a broad range of external partners, contribute to our scientific mission, and help drive new insights through HiFi data. We are looking for someone who is thoughtful, motivated to tackle challenging problems, and adaptable enough to work on projects spanning product development and applied research. Responsibilities: Build reliable, well-tested bioinformatic software and end-to-end analysis pipelines Apply bioinformatic tools to answer biological questions related to human health, including cancer and rare disease Collaborate with external partners in both academia and industry, supporting and leading projects Benchmark and evaluate bioinformatic methods Communicate scientific findings through oral and written formats, including papers, posters, and talks at national and international scientific conferences Required Qualifications: Ph.D. in a computational or biological field (e.g., bioinformatics, genetics, genomics, computer science) Strong programming skills in Rust, Python, or C++ Proficiency in analyzing large-scale sequencing datasets (e.g., genomics, transcriptomics, epigenomics, genome assemblies) Foundational understanding of cancer genetics, human genomics, or RNA biology, with interest in developing deep expertise in these areas Basic statistical skills for analyzing large datasets, including visualization, modeling, and quality control Track record of scientific publishing, including first-author manuscripts Excellent interpersonal, written, and verbal communication skills Preferred Experience: Experience working within large scientific consortia and collaborating closely with both wet-lab and computational teams Demonstrated ability to develop and maintain analysis pipelines using WDL or Snakemake Experience building and deploying containerized software (e.g., Docker or Singularity) Familiarity with modern software development practices Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: $128,800.00 - $193,200.00 To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $128.8k-193.2k yearly Auto-Apply 38d ago
  • Senior Director, Software, Platform Engineering

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health. We are now entering the century of biology and genomics is at the heart of the next revolution. Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team. Position Summary: As the Senior Director of Platform Engineering at PacBio, you will lead the teams responsible for designing, building, testing, and maintaining the platform software and infrastructure that power our next-generation sequencing systems. Your mission is to enable reliable, scalable, secure, and high-performance software delivery across the organization. You will oversee Platform Engineering and Software QA, ensuring that both development enablement and quality assurance functions work cohesively to deliver world-class software. You will collaborate cross-functionally with development, verification/validation, manufacturing, and IT teams to ensure software quality, security, reproducibility, and operational excellence. Your leadership will directly impact the efficiency, reliability, and performance of PacBio's sequencing instruments - empowering scientists and researchers worldwide. Responsibilities: Define and execute the vision and roadmap for platform engineering and software QA in alignment with company and R&D goals Provide technical leadership and strategic direction across platform, infrastructure, DevOps, QA, and secure software development functions Lead, mentor, and develop a high-performing team of platform and software QA engineers Drive continual improvement in software delivery efficiency, reliability, and scalability Own and evolve the software delivery pipeline, including build systems, packaging, deployment, and release management Establish and enforce secure development and QA practices, vulnerability management, and compliance with internal security standards Implement and optimize CI/CD pipelines, test automation frameworks, and branching/versioning strategies Oversee the development and execution of a comprehensive software QA strategy, ensuring appropriate levels of verification, validation, regression, and performance testing across all product lines Define and enforce best practices for source control, build orchestration, and environment management Collaborate with development, IT, V&V, and manufacturing teams to streamline handoffs and enhance integration processes Oversee OS configuration, performance tuning, and system-level optimization for sequencing instruments and supporting platforms Foster a culture of collaboration, transparency, and technical rigor across the software organization Required Qualifications: Bachelor's, Master's, or Ph.D. in Computer Science, Computer Engineering, or related discipline Hands-on experience with CI/CD pipelines, automated testing, and release engineering Hands-on experience deploying software to complex hardware devices 10+ years of software engineering experience, including 3+ years in a senior leadership role (Senior Manager, Director, or equivalent) and experience with formal software development Experience leading multi-disciplinary software organizations including platform engineering, DevOps, or software QA teams Strong understanding of software architecture, quality assurance principles and development best practices Track record of delivering high-quality software systems in complex, multidisciplinary environments Familiarity with regulatory compliance frameworks relevant to software development and experience working with Quality & Regulatory teams Experience in Linux systems administration, bash scripting, OS configuration, and performance tuning Familiarity with secure development practices and testing and tools for vulnerability detection and remediation Proficiency in one or more programming languages (e.g.; C++, Python, C#) Familiarity with containerization and orchestration tools (Docker/Podman, Singularity) Strong problem-solving, analytical, and cross-functional communication skills Knowledge of Agile software development and QA methodologies Experience in debugging hardware and software issues in complex computer systems with a deep understanding of system-level interactions. Strong communication skills and ability to work closely with other teams and stakeholders. Preferred Experience: Understanding of automation, infrastructure-as-code, and configuration management tools (e.g., Ansible, Puppet, Chef) Experience developing software for scientific instrumentation or regulated domains (biotech, medical devices, life sciences) In-depth knowledge of Linux internals and distributed systems Experience leading platform modernization or cloud transformation initiatives Demonstrated success in improving software delivery, platform reliability, and quality practices Understanding of FDA regulated processes Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: $259,100.00 - $388,700.00 To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $259.1k-388.7k yearly Auto-Apply 45d ago
  • Senior National Account Director - Market Access (Remote - West)

    United Therapeutics 4.8company rating

    Remote or Denver, CO job

    California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You are an expert when it comes to Market Access. You love to cultivate and manage key payer relationships with identified Managed Care Organizations (MCOs), Pharmacy Benefit Managers (PBMs), GPOs, and Governmental Payers. You have a successful history of being highly collaborative and exceptionally strategic and are ultimately looking to work for a company that is innovative and inspiring where you can truly make a difference. + Relationship Management: Establish and maintain UT's relationships with assigned National Accounts, KOL Payer stakeholders, and National Payer thought leaders. Identify and develop business relationships with the largest and most complex Payers and MCO stakeholders. Act as the primary resource for all Market Access related opportunities/issues, partnering with field sales and educating them on key managed care concepts + Strategic Planning and Execution: Identify, develop, and implement payer access strategies and product-aligned MCO business plans. Optimize UT coverage opportunities with a focus on ROI and market competitiveness. Drive new product Payer uptake, formulary access, and coverage, enhancing current UT product access + Collaboration and Communication: Communicate regularly with the National Director of Payer Engagement, Market Access leadership, and cross-functional teams (Patient Experience, Trade, Marketing, Legal, Compliance, Field Sales). Translate payer opportunities into increased revenues and communicate the payer perspective to Market Access leadership. Prepare and present formal business and product presentations to educate payers on the clinical and economic benefits of UT products + Contract Negotiation and Compliance: Negotiate and implement contracts within the guidance of UT Market Access leadership, Finance, and Legal parameters. Maintain an in-depth understanding of Pharma compliance requirements, providing guidance and leadership on compliance aspects + Leadership and Mentorship: Display leadership among Market Access peers and act as a mentor for the NAD team, providing input, direction, and encouragement. Initiate new projects to add value to the market access team, sales organization, marketing, PRC, and medical affairs. Create tools and training materials to educate internal and external customers about the department's functions + Support for UT's Subsidiary, Lung Bio Engineering (LBE): Act as the lead and expert for UT's subsidiary, LBE, by providing support in negotiating commercial contracts with Transplant Centers and OPOs. Provide reimbursement/coverage expertise and educate payers about LBE's commercial services for the transplant community + Cross-Functional Coordination: Build synergy within cross-functional groups, initiate communication for strategy meetings, and create special projects. Support senior management with payer strategies and identify key learning opportunities for the market access team Minimum Requirements + Bachelor's Degree in life sciences or a related field with 12+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry + Master's Degree with 10+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry + Proven national payer contract development, negotiation, and implementation + Current relationships with relevant MCOs + Executive level business presentation experience + Demonstrated ability to cultivate strong MCO business relationships and skilled in communicating clinical/technical information + Demonstrated success with new product launches in the MCO environment with successful pull-through implementation + Strong organizational skills and willingness to go the extra mile to make the team and organization stronger + Ability to act as a team player and support colleagues with a results-driven attitude + Proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint and Word) + Proven leadership and results managing the largest, most complex national accounts + Ability to travel 80% (including overnight travel) Preferred Qualifications + Master's Degree in life sciences or a related field + 6+ years of current relationship and knowledge of national payer landscape + 5+ years of experience in rare disease sales management + 2+ years of current experience in pulmonary arterial hypertension + Experience with market access/managed care marketing or relevant brand management Job Location This position is a remote position and will require candidates to live within the assigned territory, with preference to CA, AZ or CO. This territory includes CA, AZ, CO, WA, NV, NM, UT, ID, OR, AK, HI. The salary range for this position is $182,500 - $275,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ***************************************************** At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit *****************************************************s United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._ _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
    $182.5k-275k yearly 56d ago
  • Associate/Medical Excellence & Training Director

    United Therapeutics Corporation 4.8company rating

    Remote job

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You have a passion for training and love planning, designing, implementing, and evaluating training programs for new hires as well as continuous education for existing colleagues. You are consistent and thorough in your communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and Medical Information, just to name a few! You are flexible, thoughtful and strategic and are genuinely excited to work for a company that is innovative and inspiring! Collaborate with GMA hiring managers to develop tailored on-boarding training plan for each new GMA new hire, oversee mentoring, and facilitate new hire training meetings as appropriate. Maintain up to date onboarding materials. Occasionally assist in onboarding for non-GMA new hires in need of clinical training Execute training programs using knowledge of the effectiveness of methods such as classroom training, demonstrations, on-the-job training, role play, self-study, meetings, conferences, workshops, videoconferencing, and web-based learning Coordinate the planning process and delivery of ongoing technical training and professional development learning programs for field medical and internal GMA functions Participate in field resources workstream and oversee development of/updating of all field resources (slides, FAQ, talking points etc.) Partner with Global Medical Affairs/product development, and global partners' subject matter experts to develop/execute disease and product related training Prepare budgets and justify funds required to perform the proposed work with guidance. Develop and adjust training and learning plans based on assessment of required competencies, organizational changes, and other external factors Conduct learning needs assessments of medical affairs functions to determine training needs and priorities based on projected goals and plans Collaborate with appropriate cross functional partners to prioritize and monitor changing educational needs of field medical. Work closely with field directors to identify training needs and develop and execute plans. Participate in multiple internal workstreams and initiatives as appropriate Monitor changing Medical Affairs strategy to ensure training strategy remains relevant. Based on overall project strategy and priorities, propose, plan, and develop new learning programs or modify and improve existing programs to serve the needs of GMA colleagues. Evaluate instructor performance and the effectiveness of learning programs and provide recommendations for improvement Oversee sourcing and logistical management of trainers and/or external vendors/KOLs as required Identify knowledge gaps and design training around these gaps Identify new treatment paradigms and guidelines in each therapeutic area of interest Work with compliance to ensure all work follows policies and standards at UT Lead development of Key Intelligence questions with input from MA leadership Plan and execute pre-conference data reviews for internal teams and all GMA functions (GMI, GMS, Field) and ensure that UT data is approved and ready for field use following presentation. Associate Medical Excellence & Training Director Minimum Requirements Bachelor's Degree preferably in life sciences with 12+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or, Master's Degree - Nurse Practitioner (NP) or Physician Assistant (PA) in clinical areas of interest with 10+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or, Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) in clinical areas of interest with 7+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both 3+ years industry medical affairs experience in HCP facing roles or 3+ years of clinical or medical affairs experience in PAH/ILD therapeutic areas Current working knowledge of local legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals Extremely effective at operating in ambiguity, productive problem solving, flexibility and adaptability Adept at developing strategic plans, goals and objectives Effective at communicating at all level of leadership and individual contributors Experience effectively partnering, cultivating and maintaining collaborative relationships across functions and departments Excellent communication, presentation, organizational, and time management skills Demonstrate the ability to coordinate and implement multiple projects within a complex matrix environment as well as effectively communicate technical information to a diverse audience Must have a proactive and innovative mindset Ability to travel up to 40% Medical Excellence & Training Director Minimum Requirements Bachelor's Degree preferably in life sciences with 15+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or Master's Degree - Nurse Practitioner (NP) or Physician Assistant (PA) in clinical areas of interest with 13+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or, Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) in clinical areas of interest preferably with 10+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both 5+ years industry medical affairs training/medical excellence experience Current working knowledge of local legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals Extremely effective at operating in ambiguity, productive problem solving, flexibility and adaptability Adept at developing strategic plans, goals and objectives Effective at communicating at all level of leadership and individual contributors Experience effectively partnering, cultivating and maintaining collaborative relationships across functions and departments Excellent communication, presentation, organizational, and time management skills Demonstrate the ability to coordinate and implement multiple projects within a complex matrix environment as well as effectively communicate technical information to a diverse audience Must have a proactive and innovative mindset Ability to travel up to 40% Preferred Qualifications Prior curriculum development, education outcome assessment and application of adult learning principles Job Location United Therapeutics has the flexibility to hire this role remotely within the United States with a preference to candidates on the East Coast. The salary range for this position is $182,500 - $270,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors. In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ****************************************************** At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $182.5k-270k yearly Auto-Apply 40d ago
  • Therapeutic Specialist, Dayton, Ohio

    Insmed, Inc. 4.9company rating

    Remote or Dayton, OH job

    At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for a Therapeutic Specialist, Dayton, Ohio on the Commercial team to help us expand what's possible for patients with serious diseases. Reporting to the Regional Director, you'll in this role, you will develop, lead, and execute a sales plan with specific goals and targets to maximize sales growth in the current rare disease market. What You'll Do: In this role, you'll have the opportunity to : * Maintain exceptional knowledge of: disease state, product, customer, orphan/rare and specialty drug market, competitive landscape and the broader healthcare market place. * Demonstrate high performance driven by common values of trust, respect, and commitment to winning the right way (culture of compliance). * Foster an entrepreneurial spirit with a focus on ownership to maximize individual and company goals, establishes open and honest communication with peers and leadership. * Collaborate with cross functional partners (Market Access, Patient Support) to achieve shared business objectives in a compliant manner. * Identify and establish appropriate business relationships with emerging thought leaders and customers; demonstrated ability to recognize and devote the necessary amount of time and resources needed to engage with HCPs. * Demonstrate expert knowledge of Insmed products & disease states, customer base (HCP), business strategy and competitive environment; stay abreast of key market access issues/trends. * Perform all company business in accordance with all regulations and company policy and procedures. * Demonstrate high ethical and performance standards with all business contacts in order to maintain Insmed's exceptional reputation. Who You Are: You have a bachelor's degree with a minimum of 3 years of biotech/pharma product promotion. You are or you also have: * Experience successfully launching biotech/pharma products with a proven track record of success in exceeding goals. * Portfolio selling experience preferred. * Specialty disease experience &/or rare-orphan experience preferred. * Strong business partnerships in the Pulmonary and/or Infectious Disease community desired. * Preferred experience working compliantly in patient support models. * Strong analytical skills with the proven ability to effectively analyze data to appropriately integrate into strategic planning. * Demonstrated business acumen and a track record of accountability in exceeding territory results. * Customer relationships, interpersonal and communication skills with the established ability to effectively work with diverse audiences and influence cross functionally. * High learning agility and scientific acumen * Must have excellent communication skills (verbal and written) Where you'll Work This is a fully remote role, field based position. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Travel: This position involves frequent travel (up to 30%) for depending on the size of the geography. #LI-JTI #LI-Remote Pay Range: $155,000.00-201,500.00 Annual Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: * Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) * Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration * 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance * Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities * Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at *********************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
    $42k-60k yearly est. Auto-Apply 30d ago
  • Senior Director, Computational Biology

    Pacific Biosciences 4.7company rating

    Remote or Menlo Park, CA job

    Title: Senior Director, Computational Biology PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health. We are now entering the century of biology and genomics is at the heart of the next revolution. Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team. The Senior Director, Computational Biology is responsible for leading development of streamlined informatics solutions for HiFi sequencing data that deliver the best clinical and research genomes, transcriptomes, methylomes and metagenomics solutions. This role requires close collaboration with our customers and the scientific community to continually identify and solve the most impactful genomic problems, and plays a critical role in demonstrating what is possible with PacBio sequencing for both research and diagnostics. Responsibilities: Lead and mentor a high-performing computational biology organization supporting both research innovation and commercial products. Provide strategic guidance to translate customer needs and emerging scientific opportunities into scalable, impactful informatics capabilities. Identify and develop opportunities and collaborations which demonstrate new scientific and diagnostic applications for PacBio sequencing. Provide scientific and technical leadership across the product lifecycle. Partner closely with marketing, R&D, engineering and commercial teams to ensure alignment between scientific innovation and product strategy. Foster and lead high-impact collaborations with academic, clinical, and industry partners. Represent PacBio informatics and scientific leadership at national and international conferences, workshops, and commercial events. Lead development of informatics and computational solutions suitable for regulated clinical environments. Required Qualifications: Ph.D. in a computational or biological field (e.g., bioinformatics, genetics, genomics, computer science). Demonstrated success building scientific software that is broadly used by the genomics community. Track record of leading high-impact scientific collaborations and publications as evidenced by a strong publication record and work leading to widely adopted computational tools and methods. Demonstrated ability to drive partnerships in both academia and industry. Excellent interpersonal, written, and verbal communication skills, with the ability to engage diverse audiences. 5+ years of experience in a leadership role at a senior manager level or higher. Experience leading multidisciplinary teams and influencing across organizational boundaries. Preferred Experience: Experience in human genomics, including rare disease and/or cancer applications. Experience with long-read sequencing analysis and informatics solutions. 8+ years of experience in a leadership role at a senior manager level or higher. Experience developing and supporting software and computational tools used in regulated or clinical contexts (e.g. CLIA/CAP, FDA/IVDR, GxP). Candidates must have current authorization to work in the United States without the need for present or future sponsorship. Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite. You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. #LI-Onsite Salary Range: $259,100.00 - $388,700.00 To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at ************, or ****************************** for assistance. Visit our following pages for more information on: FAQs Benefits Culture Equal Opportunity Employment
    $259.1k-388.7k yearly Auto-Apply 6d ago

Learn more about RQM jobs

Jobs from similar companies

Jobs from similar companies you might want to view.

Zippia gives an in-depth look into the details of RQM, including salaries, political affiliations, employee data, and more, in order to inform job seekers about RQM. The employee data is based on information from people who have self-reported their past or current employments at RQM. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by RQM. The data presented on this page does not represent the view of RQM and its employees or that of Zippia.

RQM may also be known as or be related to RQM, Regulatory And Quality Solutions Llc (r&q), Regulatory and Quality Solutions LLC and Regulatory and Quality Solutions LLC (R&Q).