Knowledge of regulatory requirements for bioinformatics in drug development (FDA, EMA guidelines ... remote role. It can be performed effectively from anywhere while staying connected to your Insmed ...
Knowledge of regulatory requirements for bioinformatics in drug development (FDA, EMA guidelines ... remote role. It can be performed effectively from anywhere while staying connected to your Insmed ...
This is a fully remote position, allowing you to work from anywhere within the United States ... A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
This is a fully remote position, allowing you to work from anywhere within the United States ... A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
This is a fully remote position, allowing you to work from anywhere within the United States ... A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
This is a fully remote position, allowing you to work from anywhere within the United States ... A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA ... Proficiency in document management tools (e.g., Veeva, MS Office) #LI-Remote Candidates who are ...
Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA ... Proficiency in document management tools (e.g., Veeva, MS Office) #LI-Remote Candidates who are ...
Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
South San Francisco, CA · Remote
$127/hr
Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program ... Ensure compliance with FDA regulations and healthcare industry guidelines Qualifications:
Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
South San Francisco, CA · Remote
$127/hr
Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program ... Ensure compliance with FDA regulations and healthcare industry guidelines Qualifications:
Preparing international regulatory submissions and FDA submissions which may include device 510(k ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Preparing international regulatory submissions and FDA submissions which may include device 510(k ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA · On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA · On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA · On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA · On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Data Scientist II, Outcomes Research
Boston, MA · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Boston, MA · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Redwood City, CA · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Redwood City, CA · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Chicago, IL · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Chicago, IL · On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Boston, MA · On-site +1
$150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Boston, MA · On-site +1
$150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
... FDA Our team is comprised of Industry Leaders in Technology, Regulations and Life Sciences ... This Position is Work form Home - Remote Position for All USA location only. Compliance Group ...
... FDA Our team is comprised of Industry Leaders in Technology, Regulations and Life Sciences ... This Position is Work form Home - Remote Position for All USA location only. Compliance Group ...
Remote (EST time) Duration: Long term Position Summary We are seeking an experienced QA Lead / Test ... Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+
Remote (EST time) Duration: Long term Position Summary We are seeking an experienced QA Lead / Test ... Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA · Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Quick apply
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA · Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA · Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Quick apply
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA · Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
LIMS SME/Business Analyst
Atlanta, GA · Remote
This is a remote position so the candidate can live anywhere in the USA. The position will require ... Provide strategic direction to the IT, Scientific, and Management teams. Define data migration ...
LIMS SME/Business Analyst
Atlanta, GA · Remote
This is a remote position so the candidate can live anywhere in the USA. The position will require ... Provide strategic direction to the IT, Scientific, and Management teams. Define data migration ...
Remote Reporting to : Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin ... Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for ...
Remote Reporting to : Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin ... Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for ...
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
Quick apply
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
In support of FDA approved products, work within the Medical Science Liaison team's objectives ... LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all ...
In support of FDA approved products, work within the Medical Science Liaison team's objectives ... LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all ...
Remote Fda Scientist information
See salary details
$83.5K - $91.5K
5% of jobs
$91.5K - $99.4K
6% of jobs
$99.4K - $107.4K
12% of jobs
$108.6K is the 25th percentile. Wages below this are outliers.
$107.4K - $115.3K
12% of jobs
$115.3K - $123.3K
14% of jobs
The median wage is $124.1K / yr.
$123.3K - $131.2K
15% of jobs
$131.2K - $139.2K
11% of jobs
$140.2K is the 75th percentile. Wages above this are outliers.
$139.2K - $147.1K
11% of jobs
$147.1K - $155.1K
7% of jobs
$155.1K - $163K
4% of jobs
$163K - $171K
4% of jobs
$83.5K
$127K
$171K
How much do remote fda scientist jobs pay per year?
What is a remote FDA scientist?
What are the key skills and qualifications needed to thrive as a remote FDA scientist?
What are some common challenges faced by remote FDA scientists in maintaining effective communication with regulatory teams?
What is the difference between Remote Fda Scientist vs Remote Fda Reviewer?
| Aspect | Remote Fda Scientist | Remote Fda Reviewer |
|---|---|---|
| Required Credentials | Advanced degree in life sciences, relevant certifications | Similar credentials, often with additional regulatory training |
| Work Environment | Research labs, regulatory agencies, or remote settings | Primarily review submissions remotely, office or home-based |
| Industry Usage | Research, development, and regulatory compliance | Reviewing and approving drug, device, or food applications |
| Common Search Intent | Understanding roles, qualifications, and remote opportunities | Differences 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 cities are hiring for Remote Fda Scientist jobs?
Cities with the most Remote Fda Scientist job openings:
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The most popular types of Fda Scientist jobs are:
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States with the most job openings for Remote Fda Scientist jobs include:
What job categories do people searching Remote Fda Scientist jobs look for?
The top searched job categories for Remote Fda Scientist jobs are:

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
This job post has expired today. Applications are no longer accepted.
Job description
For patients, for each other, and for the future of science, we're in. Are you?
About the Role:
We're looking for a Senior Scientist, Bioinformatics on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Scientist, Analytical Development, you'll lead and deliver bioinformatics solutions across Insmed Gene Therapy's discovery and development programs. You will play a critical role in supporting Insmed Gene Therapy's drug discovery and development pipeline by applying computational and statistical approaches to analyze complex biological datasets. You will contribute to and lead efforts to develop tools, build analytical pipelines, perform in-depth data analysis and data modeling to support the wider science team.
What You'll Do:
In this role, you'll have the opportunity to collaborate closely with cross-functional teams spanning biology, chemistry, genetics, translational medicine, clinical development, platform development, and data science. You'll also:
- Design, develop, and maintain bioinformatics pipelines for the analysis of next-generation sequencing (NGS) data including whole-genome sequencing (WGS), whole-exome sequencing (WES), transcriptomics (bulk, single cell and spatial) and epigenomics
- Analyze data and develop interpretation reports for all facets of our drug products including comparability studies, AAV characterization studies and potency cell line characterization
- Collaborate with R&D to develop bioinformatics platforms to help identify and validate molecular biomarkers associated with disease mechanisms, patient stratification, and therapeutic response in rare disease indications
- Provide analytical and statistical rigor to empower better decision making during experimental design and result interpretation
- Present findings clearly to both technical and non-technical stakeholders; contribute to scientific publications, regulatory submissions, and internal reports
- Participate in cross-disciplinary mentoring and training of associate scientists.
- Promote data integrity by employing current Insmed best practices for data handling and storage, to empower broadscale analyses
- Manage code and result documentation using Git and GMP aligned methods to maintain accurate project history, ensure clear team collaboration and GMP data integrity
- Organize and lead projects independently, including presenting project updates to key decision makers
- Work as a key representative in Insmed's Bioinformatics & Data Science group, building collaboratively and working in partnership with members across the organization
- Support qualification and validation activities for bioinformatics pipelines and systems
Who You Are:
You have a PhD along with 5+ years of industry experience OR a Master's and 6 years of industry experience or a Bachelor's and 8 years of industry experience.
You are or you also have:
- Experience working with and analyzing NGS data (PacBio and Element Biosciences)
- In-depth understanding of statistics (Bayesian) and their application across a range of data types
- Experience coding collaboratively and using Git as part of a larger collaborative project
- Experience delivering production-quality code in Python, R, JavaScript, Go, Rust
- Experience with a python testing framework (e.g. pytest, unittest)
- Experience developing tools within a cloud environment (gcloud, AWS, Azure)
- Experience with building and deploying containerized code (Docker)
- Experience with workflow management systems (e.g., Snakemake, Nextflow, CWL)
Nice to have (but not required):
- Degree in bioinformatics, computational biology, genomics, molecular biology or a similar area
- Experience developing and releasing software for use by others
- Experience working with structured data and SQL databases
- Familiarity with popular machine learning algorithms
- Experience with single-cell and/or spatial sequencing analysis (e.g., Seurat, Scanpy)
- Knowledge of regulatory requirements for bioinformatics in drug development (FDA, EMA guidelines)
- Familiarity with FAIR data principles and bioinformatics data standards
- Familiarity with GAMP5 framework and risk-based software validation approaches
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 role requires occasional domestic/international travel (approximately 0%-15%).
#LI-REMOTE
#LI-MC1
Pay Range:
$127,000.00-165,500.00 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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 TotalRewards@insmed.com 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.
About Insmed
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
501 - 1,000 Employees
Headquarters location
Bridgewater, NJ, US
Year founded
1988