ZipRecruiter

Log In

2

Remote Fda Jobs in Farmington, MI (NOW HIRING)

Danaher

Principal Clinical Scientist

Detroit, MI · On-site +1

... remote based (can also be onsite in Chaska, MN). At Danaher Diagnostics, our vision is to be the ... Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA ...

A.N. Deringer

Import Specialist II

Dearborn, MI · Remote

$20 - $30/hr

This is a remote role that follows a Tuesday through Sunday, 4:00PM to 12:00AM Eastern Standard ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Maintains communication with ...

A.N. Deringer

Import Specialist I

Dearborn, MI · Remote

$19 - $24/hr

This is a remote role supporting a Monday through Friday, 8:00AM to 5:00PM Eastern Standard Time ... Government regulatory agencies such as FDA, EPA, USFWS, etc. * Coordinates shipping details with U.

All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Farmington, MI

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 cities near Farmington, MI are hiring for Remote Fda jobs?

Cities near Farmington, MI with the most Remote Fda job openings:

Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Farmington, MI as of August 2026, with employment types broken down into 79% Full Time, 15% Part Time, 5% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Director/Senior Director, Clinical Development

Ann Arbor, MI • Remote

ESPERION THERAPEUTICS INC
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees
Learn more about ESPERION THERAPEUTICS INCexternal

$81K - $111K/yr

Full-time

Medical, Retirement, PTO

Re-posted 16 days ago

Job description

Company Overview


Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. 


Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.


Position Title: Director/Senior Director, Clinical Development

 

The Director/Sr. Director, Clinical Development, is responsible for ensuring that Esperion assets from a clinical development perspective are aligned for success, from early clinical development, leading up to launch. The Director/Sr. Director, Clinical Development will possess a deep knowledge of the cardiovascular, metabolic, or hepatic therapeutic area landscape, an understanding of the clinical medical environment, and clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan. The Director/Sr. Director, Clinical Development will be responsible for working with the cross functional team focused on an early stage compound for primary sclerosing cholangitis.. The Director/Sr. Director will work cross-functionally to provide scientific and clinical leadership on activities including all aspects of clinical study planning, conduct, and read-out, lifecycle planning, scientific communication, and regulatory filings. The ideal candidate will have a strong scientific acumen, early phase 1 drug development experience including clinical pharmacology as well as the desire to work in a fast-paced environment, the ability to lead both strategic work as well as having high attention to detail, and a track record of working collaboratively to achieve team goals.


Preferred Location: Remote – US 


Essential Duties and Responsibilities*

  • Lead the strategy of clinical development responsibilities including, but not limited to, the following aspects of assigned clinical trials: protocol design, study population and key entry criteria, and outcomes of interest; data to be collected to accomplish the objectives of the trial and any regulatory objectives (i.e. labeling, end of phase II meeting, etc.), important study activities required to accomplish the trial or regulatory objectives (i.e. Committees needed, adjudication, etc.), and clinical aspects of the statistical analysis plan.
  • Responsible for all clinical development responsibilities for assigned studies and/or programs.
  • Works with Quality as Clinical Development SME for assigned trials
  • Works with Program Management to establish timelines of clinical development activities and key study milestones. 
  • Works with Clinical Program Lead/VP Clinical Development to ensure adequate resources are available to conduct the trial from initiation to completion for clinical development activities or other activities as assigned under this person's management.
  • Generates responses for regulatory agency's requests for information and reviews other responses to ensure clinical development related items are properly addressed.
  • Represent the company as the Clinical Development Subject Matter Expert (SME) to the FDA or other regulatory agencies as required.
  • Serve as SME for clinical development for any cross functional groups where troubleshooting is required
  • Create all aspects of study synopses, full protocols and protocol amendments and ensure these documents are compliant with project plans, federal regulations and GCP.
  • Ensure appropriate communication to the study team and the executive team at the appropriate level and frequency.
  • Serve as the SME in publications reporting data including but not limited to abstracts, manuscripts, CSRs, IB, etc.
  • Present and interpret data for both internal and external audiences

*additional duties and responsibilities as assigned


Qualifications (Education & Experience)

  • Director: BS in Sciences with a minimum of 10 years of clinical design and operational experience in the pharmaceutical industry required or equivalent education and experience
  • Senior Director: MS in Sciences and 12+ years of clinical development experience in the pharmaceutical or biotechnology industry required; or equivalent combination of education and applicable job experience. Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in clinical research within a pharmaceutical or biotech environment
  • Experience in lipid lowering and/or cardiovascular, metabolic, or hepatic space preferred but all therapeutic areas will be considered
  • Demonstrated expertise in early-stage clinical development; translational research experience is a plus.
  • Experience providing input into key regulatory documentation. Face-to-face interaction experience with FDA preferred
  • Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.

Apply