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
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
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
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
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
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
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
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
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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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.
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:
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.
To hire a freelance regulatory medical writer, the fee generally ranges from 40−100 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.
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:
Our platform makes it easier than ever before to connect and collaborate with regulatory medical writers and other regulatory affairs specialists.