ZipRecruiter

Log In

2

Remote Fda Jobs in Fort Wayne, IN (NOW HIRING)

micro1 AI

Director of Biostatistics

Fort Wayne, IN · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Regulatory Affairs Specialist

Fort Wayne, IN · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

micro1 AI

Biostatistician

Fort Wayne, IN · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Compliance Officers

Fort Wayne, IN · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

SQA Services

Quality Auditor - Pharmaceutical

Warren, IN · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Fort Wayne, IN

Remote Fda information

What is a remote FDA?

A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.

What are the typical daily responsibilities of a remote FDA compliance specialist?

A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.

What are the key skills and qualifications needed to thrive in the remote FDA position, and why are they important?

To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.

What jobs can I do completely remotely as a remote FDA?

A remote FDA typically refers to a Food and Drug Administration-related role that can be performed remotely, such as regulatory affairs specialists, quality assurance managers, or compliance analysts. These positions often require knowledge of regulations, strong communication skills, and familiarity with digital tools for document review and reporting, allowing work to be done entirely online. However, some roles may require occasional on-site visits or inspections depending on the specific job and employer policies.

What are the most commonly searched types of Fda jobs in Fort Wayne, IN?

The most popular types of Fda jobs in Fort Wayne, IN are:

What are popular job titles related to Remote Fda jobs in Fort Wayne, IN?

For Remote Fda jobs in Fort Wayne, IN, the most frequently searched job titles are:

What job categories do people searching Remote Fda jobs in Fort Wayne, IN look for?

The top searched job categories for Remote Fda jobs in Fort Wayne, IN are:

What cities near Fort Wayne, IN are hiring for Remote Fda jobs?

Cities near Fort Wayne, IN with the most Remote Fda job openings:

Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Fort Wayne, IN as of August 2026, with employment types broken down into 56% Full Time, and 44% Part Time. Highlights an 100% Remote job distribution.

Director of Biostatistics

Fort Wayne, IN • Remote

micro1 AI
Software Development • 11 - 50 employees
Learn more about micro1 AIexternal

$60 - $100/hr

Part-time

This job post has expired today. Applications are no longer accepted.

Job description

Role Title: Biostatistician


Role Type: Contractor


Location: Remote


micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI benchmarking. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Design and author expert-level evaluation tasks simulating real-world biostatistics challenges, such as clinical trial analysis, regulatory submission reviews, and observational study assessments.
  2. Source, construct, and curate authentic datasets including trial data, patient records, and protocol documents for task use.
  3. Define correct methodological solutions and defensible clinical interpretations for each evaluation scenario.
  4. Develop comprehensive, 35+ item rubrics to evaluate AI agent performance with respect to methodological rigor and clinical reasoning.
  5. Ensure all tasks reflect the complexity and depth of real-world biostatistics practice, avoiding simplified or textbook-style examples.
  6. Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific standards.


Preferred Qualifications

  1. MS or PhD in biostatistics, statistics, or epidemiology.
  2. 4+ years of experience in pharmaceutical, contract research, hospital, or academic medical contexts.
  3. Demonstrated command of clinical study design, regulatory documentation, and observational research methodologies.
  4. Advanced proficiency in R, Python, SAS, or Stata applied to real clinical or epidemiological datasets.
  5. Strong attention to methodological detail, clinical interpretation, and regulatory sensitivity.
  6. Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a plus.
  7. Excellent written communication skills and ability to author detailed grading rubrics and technical documentation.


Compensation Structure

Compensation is output-based; experts are paid per task that meets the project specifications. The time required to complete work may vary depending on the expert’s experience and workflow. Minimum submission requirements apply. Experts must submit a minimum of tasks per week.


Start Timeline & Availability

We typically fill roles within 48 hours and are looking for experts ready to jump in right away. If selected, we expect you to start your first tasks within 24–48 hours of completing onboarding.

Apply