Job Postings
AMDM posts open positions within the IVD Industry.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
Posted 2.11.21
Vice President, Quality and Regulatory Affairs, Inova Diagnostics, San Diego, CA
About Inova Diagnostics:
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
Position Summary:
Reporting into the Chief Executive Officer, the Vice President of Quality and Regulatory Affairs is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance (PPRC per IVDR) and HIPAA Privacy Officer. Provides leadership and development to assigned teams and staff. Serves as a member of Inova’s Executive Committee.
Key Accountabilities
This position is located in San Diego, CA and will require occasional travel.
Inova provides an attractive compensation and benefits package Including:
Company paid for employee:
Medical
Dental
Vision
Life Insurance
401K with a company match
Paid time off
To Apply: Send resume to ksmith@inovadx.com
COVID-19 Precaution(s):
Notice to Agency and Search Firm Representatives: Inova Diagnostics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Inova employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Inova. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you
Inova Diagnostics, Inc. Appreciates and Values Diversity.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Vice President, Quality and Regulatory Affairs, Inova Diagnostics, San Diego, CA
About Inova Diagnostics:
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
Position Summary:
Reporting into the Chief Executive Officer, the Vice President of Quality and Regulatory Affairs is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance (PPRC per IVDR) and HIPAA Privacy Officer. Provides leadership and development to assigned teams and staff. Serves as a member of Inova’s Executive Committee.
Key Accountabilities
- Establishes, implements, and manages the overall regulatory affairs, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all company products. This includes monitoring the complete manufacturing and QA/QC process to ensure conformance and compliance, as well as management of the Quality System, ensuring compliance with applicable local and international regulatory requirements and/or programs including but not limited to the regulatory requirements of the U.S., Canada and other MDSAP countries, ISO 13485, IVDD, IVDR, FDA and c-GMP guidelines and HIPAA regulations.
- As a member of the senior management team, provides sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
- Continuously identifies opportunities to improve the Quality System, product quality, simplify processes and/or reduce of the costs of quality.
- Manages the quality and regulatory staff and departmental resource needs.
- Provides leadership and management to ensure that the mission and core values of the company are put into place.
- Creates and leads a high-performing, innovative, management team that attracts, recruits, develops and retains exceptional staff.
- Reflect the values of Werfen and Inova as a role model to employees, customers, and business partners.
- Werfen People Manager competencies: Building talent, Driving for results, Customer focus, Driving for innovation, Emotional intelligence.
- Strategic thinking
- Leadership, coaching and mentoring
- Communication and influence
- Business acumen
- Financial management
- Technical Capacity
- Analysis and problem solving
- Education: Bachelor’s degree in life sciences or related field required; advanced degree or certification in Quality or Regulatory preferred.
- Experience: 10 plus years of experience in the medical device industry, including management experience required.
- Skills & Knowledge:
- Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required.
- Excellent knowledge of Quality Systems Regulations, IVDR and ISO regulations as they apply to device manufacturing required.
- Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required.
- Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required.
- Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required.
- Track record of success at building and leading high performing, complex teams.
This position is located in San Diego, CA and will require occasional travel.
Inova provides an attractive compensation and benefits package Including:
Company paid for employee:
Medical
Dental
Vision
Life Insurance
401K with a company match
Paid time off
To Apply: Send resume to ksmith@inovadx.com
COVID-19 Precaution(s):
- Remote interview process
- Personal protective equipment provided or required
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place
Notice to Agency and Search Firm Representatives: Inova Diagnostics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Inova employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Inova. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you
Inova Diagnostics, Inc. Appreciates and Values Diversity.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Posted 1.26.21
Why Grow Your Career with Covance by Labcorp?
Covance, a business segment of Labcorp, is recognized as a leader in drug development, medical device, diagnostics, crop protection and chemical testing because of our exceptional people. We embrace and celebrate the different strengths, experiences and perspectives of our nearly 65,000 enterprise team members across the globe. Our team is driven by our mission to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across life science. Join us and discover your extraordinary potential.
Job Description:
Title: Senior Medical Writer, Covance Medical Device & Diagnostics
Home-Based in the United States
Full-Time
Education/Qualifications:
Experience:
Minimum Qualifications Required:
To apply please link to job on our Career Site:
https://careers.covance.com/global/en/job/57079/Senior-Medical-Writer
For more information, please contact Michelle Moldavan, Senior Recruiter, People Experience (Px) Michelle.Moldavan@covance.com
Why Grow Your Career with Covance by Labcorp?
Covance, a business segment of Labcorp, is recognized as a leader in drug development, medical device, diagnostics, crop protection and chemical testing because of our exceptional people. We embrace and celebrate the different strengths, experiences and perspectives of our nearly 65,000 enterprise team members across the globe. Our team is driven by our mission to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across life science. Join us and discover your extraordinary potential.
Job Description:
Title: Senior Medical Writer, Covance Medical Device & Diagnostics
Home-Based in the United States
Full-Time
- Write, edit, and coordinate completion of clinical study protocols, clinical study reports (annual, interim, and final), responses to queries and deficiencies, literature reviews, clinical evaluation reports (CERs), Summaries of Safety and Performance (SSCP), Summaries of Safety and Effectiveness Data (SSED) and other clinical documents in accordance with applicable regulations and guidelines for submission to regulatory authorities.
- Write, edit and coordinate completion of abstracts, posters, presentations, manuscripts and other documents for dissemination of clinical data.
- Serve as the project manager for the writing, editing, quality control and finalization of clinical reports and protocols, including primary responsibility for the direction, scope, content and organization of specific documents in consultation with the Project Advisor, Statistician, client, Regulatory, and project team as appropriate.
- Lead the Medical Writing team on large-scale writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects.
- Act as Medical Writing lead and liaison to internal and external clients.
- Represent Covance at scientific and medical writing forums.
- Lead Medical Writing initiatives to develop and improve processes, including new technologies. Influence other department staff to accept and embrace new working practices.
- Represent the Medical Writing department at inspections, audits, and inter-department working group meetings.
- Perform literature searches/reviews to obtain background information for development of documents including protocols, clinical reports, meta-analyses, publications and other documents as required.
- Assist with study designs involving traditional epidemiological frameworks (e.g., case-control, prospective and retrospective cohort, etc.) as requested.
- Demonstrate initiative and manage Medical Writing situations independently. Present solutions and influence Management and teams to adopt recommended strategies.
- Research and assess the appropriateness of various health outcome measures. Support development of study designs and case report forms (CRFs) that utilize such measures.
- Review Statistical Analysis Plans to determine organization, table layout, and content for clinical reports.
- Provide input into CRFs in collaboration with the cross-functional study team.
- Mentor, provide guidance and train Medical Writing.
- Review and understand regulatory requirements and guidance’s regarding content for various documents and apply this knowledge to the development of submission documents. Ensure document content and style comply with appropriate regulatory requirements.
- Demonstrate knowledge of and prepare documents in accordance with Covance/client SOPs and specifications as applicable, and relevant regulations and guidance’s.
- Assist in the development and management of formats, templates and general guidelines for clinical documents, including protocols and reports.
- Assist in the development and maintenance of Medical Writing SOPs.
- Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines, and budget requirements.
- Maintain knowledge of developments in Medical Writing.
- Provide peer review and input on deliverables prepared by colleagues.
- Provide scientific leadership and support to colleagues in the Data Management and reporting team.
- Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences.
Education/Qualifications:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., Ph D or Masters) preferred.
Experience:
Minimum Qualifications Required:
- Minimum 6 years medical writing experience, including three years as medical writing project lead.
- Ability to understand and correctly interpret clinical and scientific data; ability to present data to meet key messages constructed by the clinical, regulatory, and/or marketing teams.
- Ability to interact effectively on cross-functional teams and be able to proactively facilitate effective information exchange/communication including problem solving and issue resolution.
- Knowledge of and ability to apply applicable regulatory requirements and guidelines regarding clinical research.
- Advanced knowledge of medical devices, medical terminology, regulatory submissions, data presentation and statistical methodology preferred.
- Excellent understanding of medical/scientific terminology, data analysis and interpretation.
- Strong working knowledge of MS Word, MS Excel, MS PowerPoint and citation management software, i.e., ProCite, EndNote.
- Excellent organizational and time management abilities.
To apply please link to job on our Career Site:
https://careers.covance.com/global/en/job/57079/Senior-Medical-Writer
For more information, please contact Michelle Moldavan, Senior Recruiter, People Experience (Px) Michelle.Moldavan@covance.com
Posted 1.20.21
Director of Clinical and Scientific Affairs, Pattern Bioscience
AUSTIN, TX / CLINICAL & SCIENTIFIC AFFAIRS / FULL-TIME
Click here to APPLY FOR THIS JOB
At Pattern Bioscience, we’re tackling antibiotic resistance, named by the CDC as one of the biggest public health challenges of our time. We use AI and single-cell analysis to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection, even if it is multi-drug-resistant.
But we’re not just invested in combating antibiotic resistance; we’re also invested in our people. Our team is brought together by a shared passion for our mission to cure and prevent antibiotic-resistant infections, improving one of the world's most important health decisions. We're committed to continuous learning, collaboration, and supporting one another. At Pattern, each voice matters, and we welcome diverse perspectives and healthy debate.
We're seeking a passionate and talented Director of Clinical and Scientific Affairs. In this role, you will design, lead, and publish clinical studies and programs to generate data to support regulatory clearance and commercialization of Pattern’s revolutionary ID/AST platform and tests. You will also be an ambassador for Pattern as a contributor within the scientific and clinical communities. We are seeking someone who will embrace our mission and flourish in a dynamic, rigorous, and entrepreneurial environment.
How You Will Contribute
Join us!
We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
Benefits
* Health insurance
*401k Matching
* Personalized PTO
* Transparent leadership
* Career development
* The opportunity to make a global impact and pioneer consequential solutions
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Director of Clinical and Scientific Affairs, Pattern Bioscience
AUSTIN, TX / CLINICAL & SCIENTIFIC AFFAIRS / FULL-TIME
Click here to APPLY FOR THIS JOB
At Pattern Bioscience, we’re tackling antibiotic resistance, named by the CDC as one of the biggest public health challenges of our time. We use AI and single-cell analysis to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection, even if it is multi-drug-resistant.
But we’re not just invested in combating antibiotic resistance; we’re also invested in our people. Our team is brought together by a shared passion for our mission to cure and prevent antibiotic-resistant infections, improving one of the world's most important health decisions. We're committed to continuous learning, collaboration, and supporting one another. At Pattern, each voice matters, and we welcome diverse perspectives and healthy debate.
We're seeking a passionate and talented Director of Clinical and Scientific Affairs. In this role, you will design, lead, and publish clinical studies and programs to generate data to support regulatory clearance and commercialization of Pattern’s revolutionary ID/AST platform and tests. You will also be an ambassador for Pattern as a contributor within the scientific and clinical communities. We are seeking someone who will embrace our mission and flourish in a dynamic, rigorous, and entrepreneurial environment.
How You Will Contribute
- Develop the strategy to validate and publish the performance and clinical utility of the Pattern platform and assays.
- Own the protocol design, site management, and publication of clinical studies to support Pattern strategic objectives.
- Select and contract with clinical study partner sites.
- Partner with contract research organizations as needed for management of multi-site clinical trials.
- Partner with Marketing and R&D on product strategy and requirements.
- Review and summarize scientific literature on relevant topics to build company knowledge base and support decisions.
- Prepare and present scientific content and data for relevant scientific and medical conferences.
- Create product training and education materials and contribute to sales and marketing training programs.
- Ensure compliance with Sunshine Act regulations.
- Assist in grant strategy and grant writing efforts.
- Assist with clinical specimen acquisition efforts.
- Ensure clinical studies comply with all applicable regulations and guidelines.
- Sincerely believe in rapid phenotypic AST as part of the solution to antibiotic resistance.
- Possess expertise in clinical microbiology, infectious disease medicine and antibiotic stewardship.
- Understand best practices in clinical study design, analysis, and management.
- Have published papers in top academic journals.
- Communicate well, whether written or oral.
- Practice high attention to detail and can plan and manage complex projects.
- Foster strong peer and industry relationships.
- Regularly consider and generate new ideas.
- Are flexible and adaptable to dynamic and changing business needs.
- Ph.D. or M.D. with relevant clinical experience, including leadership roles in clinical microbiology, antibiotic stewardship and/or infectious disease medicine.
- Served as a Principal Investigator or in other clinical research leadership roles at in vitro diagnostics (IVD) clinical trial sites; or have directed Clinical Affairs or Clinical Operations for IVD companies conducting clinical trials.
- Have a strong publication record in respected journals related to clinical microbiology, bacteriology, infectious disease, etc.
- Be a thought leader in the field as evidenced by speaking invitations, journal editorial positions and/or professional society leadership roles.
- Understand the needs and decision processes related to new technology adoption and reimbursement at the level of the laboratory, hospital / IDN as well as CMS and private payers.
- Approximately 25% of the year.
Join us!
We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
Benefits
* Health insurance
*401k Matching
* Personalized PTO
* Transparent leadership
* Career development
* The opportunity to make a global impact and pioneer consequential solutions
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Posted 1.20.21
Director, Regulatory Affairs , DiaSorin
North America
Reporting to the Vice President of Regulatory and Clinical Affairs, North America, you will be a hands-on leader who will provide oversight and direction regarding pre-market regulatory policy and practices for DiaSorin Inc. As a subject matter expert you will apply your expertise in translating regulatory requirements into practical, workable plans for our in vitro diagnostics product submissions and registrations; ensuring speed to market and successful submissions to obtain approval in an efficient timely manner.
You will have responsibility for activities pertaining to regulatory submission to the FDA and other Health Authorities and ensure compliance with regulatory programs such as FDA, cGMP, ISO, IVDD, GLP, CAP, and state agencies. You will thrive on the fact that this is both a management and a hands-on role that allows you to personally contribute while you are building and coaching your team.
You are self-driven, capable of figuring out what needs to be done and making it so. Your history of leading well executed 510(k) and PMA approvals will steer our efforts going forward. We will appreciate your ability to present information in a credible and authentic manner with regulatory bodies or other professional organizations. You should be excited by the prospect of working in a dynamic, entrepreneurial environment.
Why DiaSorin?
Every second, 10 lives come in to contact with one of our tests. We are the global leader in the laboratory diagnostics marketing, specializing in immunodiagnostics and molecular diagnostics segments. For over 50 years we have been dealing with diagnostics to help physicians and patients make better decisions in the most important moments.
We are a multinational company operating across 5 continents with our headquarters in Saluggia, Italy and our North American entities in the Twin Cities area of Minnesota and Cypress, California.
Your key attributes:
While this is a highlight of what you’ll do, what you’ll get is pretty great too:
This position will be located in Stillwater, MN and will require limited travel. Please contact Nick Leet, Talent Acquisition Manager @nick.leet@diasorin.com, if you’d like to hear more about this opportunity.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Director, Regulatory Affairs , DiaSorin
North America
Reporting to the Vice President of Regulatory and Clinical Affairs, North America, you will be a hands-on leader who will provide oversight and direction regarding pre-market regulatory policy and practices for DiaSorin Inc. As a subject matter expert you will apply your expertise in translating regulatory requirements into practical, workable plans for our in vitro diagnostics product submissions and registrations; ensuring speed to market and successful submissions to obtain approval in an efficient timely manner.
You will have responsibility for activities pertaining to regulatory submission to the FDA and other Health Authorities and ensure compliance with regulatory programs such as FDA, cGMP, ISO, IVDD, GLP, CAP, and state agencies. You will thrive on the fact that this is both a management and a hands-on role that allows you to personally contribute while you are building and coaching your team.
You are self-driven, capable of figuring out what needs to be done and making it so. Your history of leading well executed 510(k) and PMA approvals will steer our efforts going forward. We will appreciate your ability to present information in a credible and authentic manner with regulatory bodies or other professional organizations. You should be excited by the prospect of working in a dynamic, entrepreneurial environment.
Why DiaSorin?
Every second, 10 lives come in to contact with one of our tests. We are the global leader in the laboratory diagnostics marketing, specializing in immunodiagnostics and molecular diagnostics segments. For over 50 years we have been dealing with diagnostics to help physicians and patients make better decisions in the most important moments.
We are a multinational company operating across 5 continents with our headquarters in Saluggia, Italy and our North American entities in the Twin Cities area of Minnesota and Cypress, California.
Your key attributes:
- You are a collaborative facilitator and leader, who builds consensus while championing regulatory initiatives.
- You foster an environment that ensures the continued development of a high performing pre-market regulatory affairs team.
- You collaborate across the organization at all levels, across functional groups and geographic locations - including executive management – in a complex matrix environment.
- You likely have a Bachelor’s or Master’s degree in Science with 7-10 years direct experience in a regulatory affairs environment, primarily in the IVD industry.
- Your previous management experience with FDA product submissions is the foundation for your knowledge of U.S. and/or European/International regulations and standards in preparing regulatory submissions.
- Your professional interaction with FDA staff and/or other regulatory agencies is a known quality.
While this is a highlight of what you’ll do, what you’ll get is pretty great too:
- International business exposure
- Member of the leadership team
- Excellent compensation & benefits
- An amazing team of diverse colleagues and leaders
This position will be located in Stillwater, MN and will require limited travel. Please contact Nick Leet, Talent Acquisition Manager @nick.leet@diasorin.com, if you’d like to hear more about this opportunity.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Posted 1.15.21
TITLE: Senior Director, Regulatory Affairs - Devices and Diagnostics (Gene Therapy),
COMPANY: ultragenyx pharmaceutical
LOCATION: Cambridge, MA
DEPARTMENT: Regulatory Affairs
REPORTS TO: VP, Head of Regulatory Affairs – Gene Therapy
WORK TYPE: FULL-TIME
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. The Ultragenyx Gene Therapy division is headquartered in Cambridge, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives. Come join our team during this exciting time of growth and opportunities!
Position Summary
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx is seeking an experienced and highly motivated Sr. Director, Regulatory Affairs - Devices (Gene Therapy), who is a team builder and enjoys a fast paced, dynamic work environment. The Sr. Director will be responsible for developing and implementing global (US, EU, and other regions) regulatory strategies and processes for in-vitro diagnostics (IVDs)/ companion diagnostics (CDx’s), while also maintaining oversight of these global regulatory strategies for all projects with an IVD/CDX component. The Sr. Director will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. The responsibilities include providing critical strategic and tactical IVD/CDx global regulatory guidance that positively influences project planning and decision making. The individual will be responsible for developing and maintaining the IVD/CDx strategy template while advising on strategies that are aligned with Ultragenyx gene therapy objectives. The individual will participate in project review meetings and propose ideas to facilitate improved collaboration. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes in the area of personalized medicine, with special focus on diagnostic tests. This position will report to the Vice President of Regulatory Affairs, Gene Therapy.
Responsibilities including, but not limited to:
Leadership Skills:
Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your team and across the organization.
Provide Ongoing Coaching & Feedback: Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.
To Apply: Applicants may click on the link below to apply for this position.
https://jobs.lever.co/ultragenyx/df89edbf-fc93-4f83-8661-e936d3fcdbdd
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
See our CCPA Employee and Applicant Privacy Notice.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.
TITLE: Senior Director, Regulatory Affairs - Devices and Diagnostics (Gene Therapy),
COMPANY: ultragenyx pharmaceutical
LOCATION: Cambridge, MA
DEPARTMENT: Regulatory Affairs
REPORTS TO: VP, Head of Regulatory Affairs – Gene Therapy
WORK TYPE: FULL-TIME
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. The Ultragenyx Gene Therapy division is headquartered in Cambridge, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives. Come join our team during this exciting time of growth and opportunities!
Position Summary
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx is seeking an experienced and highly motivated Sr. Director, Regulatory Affairs - Devices (Gene Therapy), who is a team builder and enjoys a fast paced, dynamic work environment. The Sr. Director will be responsible for developing and implementing global (US, EU, and other regions) regulatory strategies and processes for in-vitro diagnostics (IVDs)/ companion diagnostics (CDx’s), while also maintaining oversight of these global regulatory strategies for all projects with an IVD/CDX component. The Sr. Director will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. The responsibilities include providing critical strategic and tactical IVD/CDx global regulatory guidance that positively influences project planning and decision making. The individual will be responsible for developing and maintaining the IVD/CDx strategy template while advising on strategies that are aligned with Ultragenyx gene therapy objectives. The individual will participate in project review meetings and propose ideas to facilitate improved collaboration. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes in the area of personalized medicine, with special focus on diagnostic tests. This position will report to the Vice President of Regulatory Affairs, Gene Therapy.
Responsibilities including, but not limited to:
- Maintain oversight of regulatory strategies for all projects with an IVD/CDx component.
- Develop and maintain the global IVD/CDx strategy, while providing regulatory input to multiple development projects.
- Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory submissions (e.g. Q-submissions, IDE applications and pre-market filings)
- Provide IVD/CDx regulatory advice to Early Development Project Leaders, Biomarker Project Leaders, Early Clinical Leaders and the respective late development roles.
- Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers globally.
- Interacting with EU and international regulatory colleagues and diagnostic partners to determine best practices and lease burdensome regulatory paths towards development and global registration activities.
- Coordinate and prepare IVD/CDx regulatory documentation in conjunction with diagnostic partners.
- Coordination with diagnostic partners for IVD documents required for inclusion in drug study Health Authority or EC filings.
- Maintains awareness of global regulatory environment and monitors key changes in the area of personalized medicine, with special focus on diagnostic tests.
- Proactively manages critical issues, taking leadership for the regulatory contribution.
- Supports the development of department policies, processes and SOPs.
- Provides regulatory due diligence assessments of new business opportunities as required.
- BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
- A minimum of 8 years of IVD, drug-related development or medical research activities and at least 8 years in regulatory affairs.
- Working knowledge of US, EU (IVDD & IVDR) and international diagnostic regulatory requirements
- Experienced with FDA interactions and submissions
- Ideally also experienced with European or international submission
- Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics.
- Good understanding of IVD development process.
- Excellent operational skills including demonstrated ability in planning, organizing and ability to motivate and lead others.
- Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders, including Senior Management.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure and acting with integrity and credibility to build trust
- Ability to deal effectively with a variety of personnel across a matrix organization
- Strong sensitivity for a multicultural/multinational environment
- Ability to prioritize and handle multiple projects simultaneously.
- Sense of urgency and perseverance to achieve results
- Rare disease and/or gene therapy experience is desirable.
- Business travel to be ~10-20% as required.
Leadership Skills:
Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your team and across the organization.
Provide Ongoing Coaching & Feedback: Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.
To Apply: Applicants may click on the link below to apply for this position.
https://jobs.lever.co/ultragenyx/df89edbf-fc93-4f83-8661-e936d3fcdbdd
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
See our CCPA Employee and Applicant Privacy Notice.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.
Posted 1.13.21
JOB TITLE: Clinical Biostatistician, Natera
JOB LOCATION: REMOTE, USA
POSITION SUMMARY:
The Clinical Biostatistician participates in analysis of clinical and genetic data while working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, clinical trials, scientific publications and product development.
PRIMARY RESPONSIBILITIES:
QUALIFICATIONS:
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual oriation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
APPLY HERE: https://jobapply.page.link/tBNQ
JOB TITLE: Clinical Biostatistician, Natera
JOB LOCATION: REMOTE, USA
POSITION SUMMARY:
The Clinical Biostatistician participates in analysis of clinical and genetic data while working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, clinical trials, scientific publications and product development.
PRIMARY RESPONSIBILITIES:
- Prepare and execute statistical analysis plans with supervision from senior team members. Produce high quality written documentation of analysis plans and results. Use statistical and clinical understanding to propose and perform analyses consistent with project objectives.
- Perform sample size and power calculations for statistical analyses of varying complexity.
- Explain statistical concepts and results to project team members and other internal stakeholders.
- When challenges arise, communicate concerns and present potential solutions to the project team.
- Write statistical sections of study plans, reports, manuscripts and other documents as needed by the project team.
- Performs other duties as assigned.
QUALIFICATIONS:
- Bachelor’s degree in statistics, biostatistics, or equivalent with 2-5 years of industry experience or Master’s degree in statistics, biostatistics, or equivalent with 0-2 years of industry experience.
- At least 2 years practical experience with data analysis software such as Matlab, Python or R (R is preferred).
- Working knowledge of advanced statistical methods including the ability to produce novel methods based on first principles understanding.
- Ability and desire to communicate in cross functional teams with members from varying background.
- Ability to produce high quality written documentation for varying audiences.
- Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual oriation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
APPLY HERE: https://jobapply.page.link/tBNQ
Posted 1.13.21
JOB TITLE: Senior Biostatistician, Natera
JOB LOCATION: REMOTE, USA
POSITION SUMMARY:
The Senior Biostatistician participates in the development of cutting edge technologies for analysis of genetic data, also working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, development, product validations, clinical trials and scientific publications.
PRIMARY RESPONSIBILITIES:
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
LINK TO APPLY: https://jobapply.page.link/gsBx
JOB TITLE: Senior Biostatistician, Natera
JOB LOCATION: REMOTE, USA
POSITION SUMMARY:
The Senior Biostatistician participates in the development of cutting edge technologies for analysis of genetic data, also working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, development, product validations, clinical trials and scientific publications.
PRIMARY RESPONSIBILITIES:
- Drive design and execution of statistical studies with a focus on innovative and efficient quantitative decision making.
- Perform sample size and power calculations for statistical analyses of varying complexity.
- Produce high quality written documentation including study plans and reports.
- Performs other duties as assigned.
- Minimum of 5 years of industry experience.
- Bachelor’s degree in statistics, biostatistics, or equivalent. MS preferred with a minimum of 3 years of industry experience.
- At least 2 years practical experience with data analysis software such as Matlab, Python or R
- Expert knowledge of advanced statistical methods including the ability to produce novel methods based on first principles understanding.
- Knowledge of SQL query language (preferred not required).
- Ability and desire to communicate in cross functional teams with members from varying background.
- Ability to produce high quality written documentation for varying audiences.
- Duties are typically performed in an office setting.
- This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
- Duties may require working outside normal working hours (evenings and weekends) at times.
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
LINK TO APPLY: https://jobapply.page.link/gsBx
Posted 1.13.21
JOB TITLE: R&D Statistician, Natera
JOB LOCATION: REMOTE, USA
JOB DESCRIPTION
The Biostatistician participates in the development of cutting edge technologies for analysis of genetic data, also working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, development, product validations, clinical trials and scientific publications.
PRIMARY RESPONSIBILITIES
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
APPLY HERE: https://jobapply.page.link/MLhQ
JOB TITLE: R&D Statistician, Natera
JOB LOCATION: REMOTE, USA
JOB DESCRIPTION
The Biostatistician participates in the development of cutting edge technologies for analysis of genetic data, also working closely with biologists and other cross functional teams. Designs and implements experiments and statistical analyses of varying complexity in the context of research, development, product validations, clinical trials and scientific publications.
PRIMARY RESPONSIBILITIES
- Drive design and execution of statistical studies with a focus on innovative and efficient quantitative decision making.
- Perform sample size and power calculations for statistical analyses of varying complexity.
- Produce high quality written documentation including study plans and reports.
- Performs other duties as assigned to drive design and execution of statistical studies with a focus on innovative and efficient quantitative decision making.
- Performs other duties as assigned.
- Bachelor’s degree in statistics, biostatistics, or equivalent; MS preferred.
- At least 2 years practical experience with data analysis software such as Python, Matlab or R
- Working knowledge of statistical methods including the ability to produce novel methods based on first principles understanding.
- Knowledge of SQL query language (preferred not required).
- Ability and desire to communicate in cross functional teams with members from varying background.
- Ability to produce high quality written documentation for varying audiences.
- Duties are typically performed in an office setting.
- This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
- Duties may require working outside normal working hours (evenings and weekends) at times.
OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
APPLY HERE: https://jobapply.page.link/MLhQ