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Senior Quality Engineer

Chicago, IL · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or ...

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Senior Quality Engineer

Redwood City, CA · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or ...

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New York, NY · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or ...

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How much do remote fda scientist jobs pay per year?

As of Jun 9, 2026, the average yearly pay for remote fda scientist in the United States is $127,031.00, according to ZipRecruiter salary data. Most workers in this role earn between $109,000.00 and $143,500.00 per year, depending on experience, location, and employer.

What is a Remote FDA Scientist?

A Remote FDA Scientist is a professional who works for or with the U.S. Food and Drug Administration (FDA) from a remote location, rather than onsite at an FDA facility. These scientists are involved in a variety of regulatory, research, and review activities related to food, drugs, medical devices, or other products overseen by the FDA. Their responsibilities may include evaluating scientific data, reviewing submissions from manufacturers, and ensuring products meet safety and efficacy standards. Remote FDA Scientists typically collaborate with colleagues and stakeholders through virtual communication tools while maintaining strict compliance with federal guidelines.

What is the difference between Remote Fda Scientist vs Remote Fda Reviewer?

AspectRemote Fda ScientistRemote Fda Reviewer
Required CredentialsAdvanced degree in life sciences, relevant certificationsSimilar credentials, often with additional regulatory training
Work EnvironmentResearch labs, regulatory agencies, or remote settingsPrimarily review submissions remotely, office or home-based
Industry UsageResearch, development, and regulatory complianceReviewing and approving drug, device, or food applications
Common Search IntentUnderstanding roles, qualifications, and remote opportunitiesDifferences in responsibilities, qualifications, and remote work

Remote Fda Scientists focus on research and development activities, while Remote Fda Reviewers primarily evaluate submissions for approval. Both roles require similar scientific credentials and often operate remotely within the regulatory industry. The main difference lies in their core responsibilities: scientists conduct research, whereas reviewers assess regulatory submissions.

What are the key skills and qualifications needed to thrive as a Remote FDA Scientist, and why are they important?

To thrive as a Remote FDA Scientist, you need a strong background in life sciences or a related field, advanced analytical skills, and experience with regulatory compliance, often supported by a relevant degree (such as a PhD or MS) and prior FDA or industry experience. Familiarity with data analysis tools, regulatory submission systems (like eCTD), and quality management software is typical. Excellent written communication, attention to detail, and the ability to work independently are vital soft skills in this role. These competencies ensure accurate scientific evaluation, effective regulatory submissions, and compliance with FDA standards while working remotely.

What are some common challenges faced by Remote FDA Scientists in maintaining effective communication with regulatory teams?

Remote FDA Scientists often navigate the challenge of ensuring clear and timely communication with cross-functional regulatory teams, especially when working across different time zones. This role requires proactive use of collaboration tools, regular virtual meetings, and detailed documentation to keep everyone aligned on project goals and compliance requirements. Building strong relationships with colleagues and setting clear expectations for updates and feedback can help mitigate miscommunication and support project success. Additionally, staying organized and being responsive to regulatory changes are key to thriving in a remote environment.
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Remote Fda Scientist jobs near you
Scientific Director, Health Systems

Scientific Director, Health Systems

Madrigal Pharmaceuticals

Seattle, WA • Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 17 days ago

Job description

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR- agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Role Summary:

The Health Systems Regional Scientific Director (HSRSD) is a therapeutic and disease expert who develops on-going professional relationships with healthcare decision makers within defined regional payer organizations (e.g., health plans, PBMs, integrated delivery systems (IDN), large GI practices, specialty pharmacy and other key health systems in the assigned region.

The HSRSD provides accurate information about Madrigal products and related disease areas, clinical science and HEOR/real-world research/evidence in a balanced and credible manner consistent with the regulatory environment and Madrigal's ethical standards. Serves as a resource for the Global Medical Affairs (GMA) management team on strategic planning and provides mentoring for other team members. Works closely with account executives and key account managers, as well as other field medical colleagues to address the scientific needs in the region.

Open to candidates in Washington, Oregon, Idaho, Wyoming, Utah, Colorado, Kansas, Nebraska, North & South Dakota

Primary Activities:

  • Develops ongoing professional relationships with key decision makers in organized health systems to ensure access to medical and scientific information on Madrigal's products, development programs and related disease area(s).

  • Partners with the Market Access and Key Account Director (KAD) teams to develop strategic account plans; execute medical activities in alignment with agreed plan.

  • Effectively communicates and coordinates with regional MSLs and CPLs regarding medical and scientific support needs in key affiliated regional health systems - IDNs, GI practices and regional payers.

  • Serves as a resource for the Health Systems Executive Director and other members of market access and KAD organizations on other relevant strategic planning.

  • Provides support for HEOR activities led by HQ HEOR within regional accounts of responsibility.

  • Serves as a technical resource on questions raised by market access and KAD team members.

  • Attend and support scientific and medical meetings. Prepares planned post-meeting deliverables.

Required Skills:

Minimum:

  • Clinical or scientific degree required (e.g., MD, PharmD, PhD, MS, MPH, etc.).

  • 5+ years' experience in IDN and payer space and the ability to develop peer-to-peer relationships with key decision makers; may be gained through working on the customer side or in an industry role working with these customers. Must demonstrate a thorough knowledge of payer and IDN organizational practices.

  • Thorough knowledge of clinical medicine, the managed market environment, pharmacoeconomics, disease management, real-world evidence generation and medical research

  • Business and market knowledge, including quality management, formulary management and pathway development/management.

  • Excellent interpersonal communication skills, strong presentation skills, ability to work with cross functional field account teams, strong personal integrity, collaborative mindset, and strong customer focus are necessary.

  • Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines, laws and regulations relevant to the pharmaceutical industry

  • Must be able to organize, prioritize, and work effectively in a constantly changing environment, and have demonstrated project leadership abilities.

. Preferred:

  • Formal training in health economics or outcomes research

#LI-Remote

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $240,000- $265,000 per year.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.

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