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Top Freelance Regulatory Medical Writers For Hire
MBA Quality Management
Brazil
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USD 50/hr

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

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USD 50/hr
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USD 120/hr

I am a freelance medical and science writer with eight years of research experience in cancer immunotherapy. I obtained a MSc in pathobiology a..., communicating science with young students during volunteering activities, and writing for various publicationsmanaged several projects with national and international collaborators resulting in grant funding and publications

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USD 120/hr
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PhD
United States
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USD 50/hr

As a scientist with over 20 years experience of project management, technical writing, teaching and the regulatory landscape; I have developed ...

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USD 50/hr
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PhD
United States
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USD 45/hr

✏️ I am a scientific writer and editor who enjoys the challenge of communicating highly technical or specialized information in the cleare...

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USD 45/hr
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MD (Doctor of Medicine)
Sri Lanka
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USD 50/hr

I am a medical doctor and a medical writer for the past 6 years. I have worked with many researchers, surgeons, dermatologists, nephrologists, ...I have assisted them with their publications (journal articles, review articles), CME modules, e-learning

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USD 50/hr
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Diploma in Applied Epidemiology
India
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Experienced Medical Writer with a demonstrated history of working in the pharmaceutical industry and research organizations of international re...

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USD 150/hr

Medical writer with experience in pharmacoeconomics, pharmaceutical policy, health policy, and health services research.

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USD 150/hr
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MS
India
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USD 70/hr

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...gt; Feasibility survey reports, disease demographics > Standalone QC and review of documents Publicationwriting services include: > Publication planning > Primary and secondary manuscript writing

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USD 70/hr
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PhD in Biochemistry
Israel
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USD 60/hr

I am a PhD enzymologist and protein biochemist with over 30 years experience in the biopharma and industrial biotechnology sectors, including 1...

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USD 60/hr
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Doctor of Pharmacy
United States
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USD 110/hr

I am a US-based doctor of pharmacy with board certification in pharmacotherapy (BCPS). I bring a clinician's eye to your medical writing p...

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USD 110/hr
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I have experience in medical publication writing like research papers writing , systematic review writing , Meta analysis writing , literature...I have experience in medical publication writing like research papers writing , systematic review writingI am an expert in writing publication.Worked on more than 100 international publications for various global clients I am a highly-skilledradiology, infection control, Gastroenterology,oncology, medical science, health and medicine, virology, public

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USD 40/hr
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Ph.D. Pharmaceutical Sciences
United States
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USD 90/hr

Pharmaceutical/Nutraceutical/Food Formulation Scientist with 20+ years of experience developing soft chews, tablet and capsule products, chewab...

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USD 90/hr
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Masters in Pharmacy (Pharmacology and Toxicology)
United States
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USD 50/hr

I am an experienced health professional, having 6+ years of thorough working experience in clinical research and the therapeutic research indus...

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Bachelors of Science in Biochemistry
Switzerland
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USD 200/hr

I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...

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USD 200/hr
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Bsc in Biomedical Engineering
Pakistan
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USD 50/hr

An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...

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USD 50/hr
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PharmD (Pharmacist-Chemist, Provisor)
Armenia
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USD 50/hr

In my experience as a RA CMC specialist, I am responsible for: • Work with CTD dossier Module 1 trough Modul 5 • Coordination of the project (c...

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USD 50/hr
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Master of Public Health (M.P.H.), Fundamentals of Clinical Trials
India
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USD 90/hr

A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...A strong background in viorology, medical microbiology and public health qualifies me to work on COVIDtop rated writer & editor with emphasis on medical writing, scientific journal manuscripts, public

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USD 90/hr
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Speed Woman Mentoring
Brazil
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USD 40/hr

Graduated in Biological Sciences (Bachelor's degree) at São Camilo University Center (2008). Science Master’s degree (2012) and Ph.D. ...

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USD 40/hr
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BS- Nursing
United States
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USD 150/hr

More than 17 years working as Health Care Consultant for different companies and agencies, as well as a professor from a private and public un...Health Care Consultant for different companies and agencies, as well as a professor from a private and public

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USD 150/hr
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Doctor of Philosophy (Ph.D, Pharmaceutical sciences)
India
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USD 30/hr

I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified Information Mapping Professional™ (IMP) a...I am a Doctorate (PhD) in Pharmacy, a Certified Medical Publication Professional™ (CMPP), a certified

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USD 30/hr
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MS
India
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USD 30/hr

I am works in the capacity of Principal Biostatistician, independently on all phases of complex clinical trial projects, often with major regul...Nursing, Radiation oncology, Medical media, Transplantation, Biomarkers, Immunology, Epidemiology, Public Knowledge of SOP, additional analysis to support publications (& thesis, PhD thesisTrials Clinical research Group-sequential and adaptive trial design Exploratory analyses for publicationsCourses / Training Programs Short Course in Biostatistics & Epidemiology for Clinical and Public

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USD 30/hr
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PhD
United States
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USD 100/hr

Industry leader with 20+ years of expertise in the clinical trial, drug development space. PhD Biotech, Adv Dip French Literature. Have represe...Have over 30 publications to my credit and have served on the Editorial Board of the Journal of AppliedPublications 1. Limaye N. Data Integrity – It’s really about your integrity!My interview was published as an Outstanding Women Leader in Tanishka, a local publication in Sep’12Data Basics (an SCDM publication), 13.4, 18. 27.

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USD 100/hr
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Ph. D in Pharmaceutical science
India
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USD 30/hr

I am an experienced ‘Formulation Scientist’ offering outstanding product development skill for oral liquids, Tablets, parenteral products, OTC ...

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USD 30/hr
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Certificate in Leadership & Performance Management
South Africa
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USD 100/hr

I provide clinical research and health consulting, medical writing and training services to Pharma, Biotechnology Companies, CROs, NGOs, Founda...

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USD 100/hr
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MD
United States
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Mark Luhovy, MD is a medical doctor and biomedical engineer who has dedicated 20 years to the pursuit of understanding the intersection of medi...

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Consult top freelance regulatory medical writers with expertise in clinical regulatory writing, regulatory writing services, and more. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants.

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How to hire an expert in regulatory writing

New drugs and medical devices need to navigate the complex maze of clinical trials and regulatory approval before they can go to market. In the process, a myriad regulatory documents need to be drawn up. With increasing numbers of drugs and medical devices being submitted for approval, there is a growing demand for regulatory documents that are compliant, scientifically sound, and well-written. Regulatory writing has, therefore, become a recognized niche within the pharmaceutical and medical device industries.

What does a regulatory writer do?

Regulatory writers work with regulatory agencies and various medical, technical, and operations professionals to draw up and review documents related to the different phases of clinical trials and market authorization. These documents need to adhere to the guidelines for Good Clinical Practice (GCP) according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and they need to conform to the requirements of the relevant regulatory agencies (e.g., FDA, EMA) and institutional review boards (IRBs).

The various documents that regulatory writers work on include:

  • Clinical study applications (CTAs)
  • Common technical documents (CTDs)
  • Investigational new drug applications (INDAs) and investigational medicinal product dossiers (IMPDs)
  • Clinical trial study reports (CSRs)
  • Marketing authorization applications (MAAs)
  • Integrated summaries of efficacy and safety
  • Periodic safety update reports (PSURs)
  • Informed consent forms
  • Risk management plans (RMPs)
  • Pediatric investigation plans
  • Proposed pediatric study requests
  • Pediatric use marketing authorizations (PUMAs)
  • New drug applications (NDAs)
  • Post-marketing documentation
  • Investigators’ brochures
  • Applications for orphan drug designations
  • Requests for product-specific waivers
  • Drafting response documents to address issues raised by regulatory agencies
  • Clinical evaluation reports (CERs)
  • Labeling regulatory documents (Summary of Product Characteristics, SmPC)

Experts in regulatory writing will typically be medical writers with several years of experience writing for a contract research organization (CRO) or pharmaceutical company. They usually have a PharmD, MD, or a Master’s or Ph.D. degree in an allied scientific field. They will have extensive knowledge of the regulatory requirements relevant to their region (e.g., FDA or EMA), as well as the ICH guidelines.

Regulatory writers work either as freelance medical writers or regulatory affairs consultants or for CROs, medical device or pharmaceutical companies, medical writing agencies, regulatory and governmental agencies, and regulatory affairs consultancies. The job titles of regulatory writing experts vary and can include Medical Writer, Regulatory Writer, Regulatory Submission Writer, Associate Medical Writer, Senior Regulatory Affairs Medical Writing Associate, and Senior Medical Writer. While some may be generalists, others may specialize in e.g., biologics or medical device regulatory writing.

How much does it cost to hire a freelance regulatory writer?

To hire a freelance regulatory medical writer, the fee generally ranges from 40100 USD per hour depending on the required skillset and the level of experience necessary.

The hourly fee can be negotiated upfront based on the estimated number of project hours, or a flat fee (for projects of a defined scope) can be discussed. If you need short-term/temporary access to these specialists, then hiring a freelance regulatory writer or regulatory affairs consultant on our platform is a convenient and cost-effective way to harness their expertise.

How do you write an effective job post to hire an expert regulatory writer?

The best way to attract the top Kolabtree freelancers in this field is to make your project description informative. You will need to provide information on the following:

  • Skills required (e.g., expertise in medical device regulatory writing)
  • What the project area is (e.g., development of a biorobotics device)
  • What the project entails (e.g., ensuring regulatory compliance with EMA and MDR guidelines)
  • What the deliverables are (be specific about what you need the outputs to be)
  • Duration of the project (provide an estimate of how many hours work you will need per week/by when you need the project to be completed)
  • By when you need to hire (having more leeway on this will give you more time to choose the best expert for your needs)
  • Your budget (per hour or fixed fee)
  • If you are unsure what exactly is required, providing as much detail as possible will allow the experts to still make an informed bid for your project and suggest the best routes forward.

Our platform makes it easier than ever before to connect and collaborate with regulatory medical writers and other regulatory affairs specialists.

Related skills

Clinical Research          Clinical Trials          Drug Development           FDA Submissions          Medical Device                                                                                                                           Medical Sciences          Medical Writing          Pharmaceutical Industry           Product Development           Regulatory Writing           Technical Writing