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Top Freelance Regulatory Medical Writers For Hire

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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USD 125/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...

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USD 125/hr
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Master of Business Administration
Malaysia
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USD 40/hr

Regulatory technical writer with experiences in the medical device, pharmaceutical, and cosmetic industries. Demonstrate extensive knowledge in...

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USD 40/hr
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PhD in Pharmacy
Armenia
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USD 50/hr

My science qualification is Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford Univers...

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USD 50/hr
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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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PhD Community Medicine
United States
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USD 200/hr

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 200/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, ...

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USD 50/hr
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USD 40/hr

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

Pharmaceutical/Nutraceutical/Food Formulation Scientist with 30+ years of experience developing soft chews, tablet and capsule products, chewab...

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USD 90/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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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...

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USD 70/hr
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USD 50/hr

CV • Progressed from fundamental multidisciplinary research (Chemistry, Nanobiotech, Biochemistry) to in vitro Pharmacology (Cell Biology, Targ...

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USD 50/hr
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USD 50/hr

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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USD 75/hr

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

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USD 75/hr
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USD 125/hr

After completing MBBS from the All India Institute of Medical Sciences, New Delhi. He pursued MD in Radiodiagnosis from SMS Medical College and...

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USD 125/hr
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MBA Quality Management
Brazil
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USD 69/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 69/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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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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Master in Pharmacy
India
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USD 195/hr

During my journey as an employee, i have learned in-depth process of drug from its inception to market. Expertise in clinical trials, BA/BE stu...

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USD 195/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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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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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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USD 45/hr

• Broad research and knowledge base in virology, molecular biology, drug target discovery, vaccine development, bioinformatics, antibody develo...

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USD 45/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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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