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Top Freelance Regulatory Medical Writers For Hire

Dr. Julia Jenkins

PhD in Biochemistry and Medical Writer with 20+ years of experience
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USD 50/hr
PhD
United States

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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Dr. Shrinidh Joshi

PhD in Pharmaceutical Science with 11+ years of experience in Pharmaceutical - Clinical - Regulatory- Medical writing
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USD 70/hr
Doctor of Philosophy (PhD)
Canada

I am an agile, performance-driven and critical problem solver scientist with a passion for scientific consulting, disseminating strategic, stre...

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USD 70/hr
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Dr. VANOJAN MANICKANADARAJAH

Medical Writer and Editor
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USD 50/hr
MD (Doctor of Medicine)
Sri Lanka

I am a medical doctor and a medical writer for the past 5 years. I have worked with many researchers, surgeons, dermatologists, nephrologists, ...

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USD 50/hr
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Dr. Sanet Aspinall

Experienced clinical research and health consultant providing consulting, training and medical writing.
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USD 100/hr
Certificate in Leadership & Performance Management
South Africa

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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Dr. Dr akshay MD Senior medical writer And clinical researcher

Senior Medical writer with 10 years experience( Research papers, systematic review, Meta analysis, literature reviews
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USD 40/hr
Dr
India

I have experience in medical publication writing like research papers writing , systematic review writing , Meta analysis writing , literature...

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USD 40/hr
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Dr. Sonika Verma

Medical Writer and researcher having 10 years of post qualification experience in clinical and epidemiological research.
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Diploma in Applied Epidemiology
India

Experienced Medical Writer with a demonstrated history of working in the pharmaceutical industry and research organisations of international re...

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Dr. Neha Pawar

Medical Writer Teach For Free
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USD 12/hr
Ph.D (Pharmacology)
India

Neha Pawar, with a basic pharmacy degree (pharmacist) is specialized in Pharmacology (Masters and Ph.D.) from renowned institutes, is a success...

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USD 12/hr
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Rudra Patel

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
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USD 70/hr
MBA
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

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USD 70/hr
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Dr. Stuart Cantor

Scientist/Consultant w/R&D & Manufacturing Expertise in Pharmaceutical/Nutraceutical/Food/Cannabis Industries
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USD 90/hr
Ph.D. Pharmaceutical Sciences
United States

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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Alifiya Tahir

Clinical Research Scientist & Medical Writer with 5+ years of experience in academia & pharmaceutical industry
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USD 10/hr
Master of Public Health (Epidemiology & Biostatistics)
United States

I am a research scientist/medical writer trained in clinical sciences, epidemiology and biostatistics (BDS, MPH, Rutgers University, USA). My p...

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USD 10/hr
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Dr. Ana Luiza Cassin Duz

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 50/hr
MBA Quality Management
Brazil

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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Dr. Nare Simonyan

PhD in Pharmaceutical Science with experience in Regulatory Affairs CMC (Chemistry, Manufacturing and Control) .
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USD 40/hr
PharmD (Pharmacist-Chemist, Provisor)
Armenia

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

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USD 40/hr
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Dr. Mathew Weisman

Life Sciences Consultant, Writer, and Editor
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USD 60/hr
PhD in Biochemistry
Israel

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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Bharti Sharma

Freelance medical writer, COVID-19 virologist, Coronavirus expert, CER writer, MDR Consultant, Scientist, clinical trial
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USD 90/hr
Master of Public Health (M.P.H.), Fundamentals of Clinical Trials
India

A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...

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USD 90/hr
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Dr. Codette Pharma Regulatory Analytics Pvt Ltd

One stop solution for end to end Life Sciences global Regulatory support.
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USD 50/hr
PhD
India

Codette Pharma Regulatory Analytics Pvt Ltd provides top-level global regulatory and clinical support to Life Science companies. We are experts...

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USD 50/hr
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Dr. Killian Kleffner, PhD

Scientific Writer with 13+ years experience in regulatory and clinical affairs
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USD 45/hr
PhD
United States

✏️ 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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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...

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USD 100/hr
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Nida Ali

Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries
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USD 50/hr
Bsc in Biomedical Engineering
Pakistan

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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Dr. Atul Kolte

Formulation Chemist | Formulation Scientist | Regulatory affair
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USD 25/hr
Ph. D in Pharmaceutical science
India

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

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USD 25/hr
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Dr. Katrina A. Bramstedt, PhD

Bioethicist, Research Ethicist, IRB/REC Expert
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USD 150/hr
PhD Community Medicine
United States

I have reviewed 2000+ research protocols and helped created hundreds of consent forms for complex research studies. I'm an expert with the...

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USD 150/hr
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Denise Arrington

Experienced Medical Device Global Quality and Regulatory Professional
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Bachelor's of Science and Associates of Business Administration
United States

I am an experienced Quality and Regulatory professional with over 25 years in the medical device manufacturing industry. I have worked with Cla...

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Waqas A. K.

Regulatory Affairs / Quality Operations Professional (Pharmaceuticals) | RA Freelancer & Consultant
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USD 150/hr
Double Masters
Pakistan

PROFESSIONAL PROFILE: A Regulatory Affairs/ Quality Operations Professional with thirteen years drug development experience (Pharmaceutical), w...

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USD 150/hr
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Anwesha Mandal

Medical writer with 3+ years experience in Scientific Publications
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USD 20/hr
Masters in Pharmacy
India

My responsibilities include literature search, editing, writing and reviewing process for the development of scientific publications (abstracts...

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USD 20/hr
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Lini Subin

Regulatory Affairs Expert with 16 Years Experience (Regulatory and Scientific Writing Services)
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USD 150/hr
MSc Pharmaceutical Chemistry
India

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory St...

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USD 150/hr
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Anitha Rajagopalan

Independent Medical Researcher/ Writer : Adding a human voice to your medical content.
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USD 45/hr
Advanced Clinical Research Graduate Certificate
United States

A Healthcare Professional with 12 years of experience in medical devices and Pharmaceuticals. Astute writer with excellent copy editing skills ...

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USD 45/hr
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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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Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.

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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