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Online Training - Medical Writing / Scientific Writing with Experience Certification & Placement Assistance, Medical Writing / Scientific Writing certificate course in Hyderabad, India consists of online Medical Writing training / online Scientific Writing training for the students across the Globe to Countries like India, USA,UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada over World Wide Web. Medical Writing online Training / Scientific Writing online Training also offered in Hyderabad, Chennai, Bangalore, Mumbai, Pune, Delhi, Kolkata. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Writing Training in Hyderabad, best Medical Writing Training in Chennai, best Medical Writing Training in Bangalore, best Medical Writing Training in Mumbai, best Medical Writing Training in Pune, best Medical Writing Training in Delhi, best Medical Writing Training in Kolkata, best Medical Writing Training in India. Medical Writing / Scientific Writing online training institute features include Interactive one to one online live sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Online Training via Skype/TeamViewer with course material and resume preparation tips.

Online Training - Medical Writing / Scientific Writing with Experience Certification & Placement Assistance

BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Medical Writing Training in Hyderabad since the year of 2000. Online Medical Writing Training in Hyderabad, India includes best Medical Writing Training online Institute that imparts knowledge about Clinical Trial Documents. Medical writing certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Writing Training in USA, best Medical Writing Training in UK, best Medical Writing Training in Australia, best Medical Writing Training in Germany, best Medical Writing Training in Sweden, best Medical Writing Training in Netherlands, best Medical Writing Training in Singapore, best Medical Writing Training in Europe, best Medical Writing Training in Canada. Training in Online Medical Writing is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. With the rising innovations and the rapid growth in healthcare sector, the demand for medical documents especially pertaining to clinical research has been increased. Medical Writing, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry. Overall, medical writing is one of the most promising careers nowadays, owing to the growth opportunities. Rapid growth in the Medical Writing / Scientific Writing business has translated into a huge demand in the number of Medical Writers. Life Sciences, Pharmaceutical Sciences and Medical Graduates, Post Graduates and PhDs have started moving into Medical Writing / Scientific Writing sector. Professional are seeking Medical writing as the preferred choice for their careers across the Globe like India, USA, UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada.

Medical Writing Training

Medical Writing Training equips you the knowledge related to Safety Writer Jobs, Clinical Medical Writer Jobs, Medical Affairs Writer Jobs, Medical Regulatory Writer Jobs, Scientific Writer Jobs in addition to Medical Writer Jobs.

Medical Writing Training / Safety Writing Training in Clinical Research focuses on the documents that need to be submitted to the regulatory authorities at various stages of a clinical trial. Medical Writing is required through the entire life cycle of a drug - starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market. The process for new drug approvals relies heavily on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome.

Are you looking for an opportunity to support a business creating life-saving treatments   If you're looking to boost your career prospects in the pharmaceutical industry, medical writing training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, Medical Writing training is crucial. Compliance to European and American Medical Writing regulations is important as enormous opportunities available in United States of America, United Kingdom and other European Countries.

Brexit and implementation of the new regulatory base of Medical Writing in the UK as well as in the Eurasian Economic Union (EAEU) countries, have transformed Medical Writing to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Medical Writing has been discussed as a concept for integrated regulations. Considering the recent developments, we are Getting Closer Harmonized systems.

Medical Writing Training Online

Looking for professional medical writing training / safety writing training   If you hold an associate's degree or higher and want to advance your career in Medical Writing or want to increase your skillset with the Safety Writing, our Online Training - Medical Writing/Scientific Writing with Flexible Timings & Experience Certification with Placement Assistance is right for you to boost your career. Our Medical Writing training online / Safety Writing training online focuses on ICH-GCP/FDA (US)/EMEA (Europe, the Middle East and Africa)/Canada (Health Canada)/TGA (Australia)/MHRA (UK) guidelines. Unique program designed for professionals aspiring to make a career in Medical Writing / Safety Writing.

Online Training Features

  • Web based classroom
  • One faculty/student
  • Placement support
  • Regular/Fast track/Weekend individual slot
  • Flexible timings
  • Training Mode: Skype/Teamviewer

Certification

Course Certificate & Job Experience Certificate would be awarded at the end of the program.

Course Curriculum

  • Clinical Study Reports (CSRs)
  • Clinical Study Protocol
  • Clinical Protocol Amendments
  • Clinical Trial Reports
  • Patient Safety Narratives
  • Narratives for Adverse Drug Reactions & Adverse Events
  • Regulatory Documents
  • Quality Checks QC / Quality Review QR
  • US FDA Guidelines
  • EU & Other Foreign Regulations
  • Drug Development Process
  • Global Regulatory Submissions
  • New Drug Application (NDA)
  • IND Submissions
  • Abbreviated New Drug Application (ANDA)
  • Institutional Review Board (IRB)
  • Electronic Code of Federal Regulations (eCFR)
  • Independent Ethics Committee (IEC)
  • Investigator Brochures (IBs)
  • Informed Consent Forms (ICFs)
  • Data Collection Documents
  • Source Documents
  • Investigational Medicinal Product Dossier (IMPD)
  • Standard Operating Procedures (SOPs)
  • ICH/GCP Guidelines
  • Case Report Forms (CRFs)
  • eCRF
  • Regulatory Submission Documents
  • Aggregate Safety Reports
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)

You will be extensively involved in

  • Reviewing Clinical Study Reports (CSRs)
  • Clinical Trial Protocol Review
  • Reviewing Informed Consent Forms, Case Report Forms
  • Clinical Data Quality Check
  • Writing Patient Safety Narratives
  • Knowledge about Drug Development Process
  • Quality Review of Regulatory submission documents
  • Reviewing IB, SOPs
  • Knowledge about US FDA/EU/ICH-GCP Guidelines
  • Regulatory Submission Documents Review
  • Review of Aggregate Safety Reports : Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs)

Medical Writing Associations

  • American Medical Writers Association (AMWA)
  • European Medical Writers Association (EMWA)
  • Australasian Medical Writers Association (AMWA)
  • Indian Medical Writers Association (IMWA)
  • Chinese Medical Writers Community (CMWC)

Global Medical Writing Regulations

Medical writing involves the creation of scientific documents that comply with regulatory requirements for the development, approval, and post-market surveillance of medical products. Regulations governing medical writing vary by region. Below is a summary of global regulations and guidance that influence medical writing activities:

    Oceania

    Australia
  • Regulatory Body: Therapeutic Goods Administration (TGA)
  • Regulations:
  • Australian Regulatory Guidelines for Prescription Medicines (ARGPM).
  • ICH E3 (Structure and Content of Clinical Study Reports).
  • ICH M4 (Common Technical Document, or CTD).
  • New Zealand
  • Regulatory Body: MEDSAFE
  • Regulations:
  • Follows ICH guidelines.
  • North America

    United States
  • Regulatory Body: Food and Drug Administration (FDA)
  • Regulations:
  • FDA 21 CFR Parts 312 and 314.
  • FDA Guidance for Industry on Clinical Study Reports.
  • Safety reporting must comply with FDA's eCTD requirements.
  • Canada
  • Regulatory Body: Health Canada
  • Regulations:
  • Comply with the Health Canada Guidance.
  • Follows the ICH Efficacy and Safety Guidelines.
  • Central/South America

    Brazil
  • Regulatory Body: ANVISA
  • Regulations:
  • Follows the ICH and WHO guidelines.
  • Mexico
  • Regulatory Body: COFEPRIS
  • Regulations:
  • Medical writing adherence to COFEPRIS.
  • Europe

    European Union
  • Regulatory Body: European Medicines Agency (EMA)
  • Regulations:
  • EU Clinical Trial Regulation (CTR) 536/2014.
  • Common Technical Document (CTD) format is mandatory.
  • Adherence to ICH E3, E6 (GCP), and E9.
  • United Kingdom
  • Regulatory Body: Medicines and Healthcare products Regulatory Agency (MHRA)
  • Regulations:
  • UK adopts a CTD-compliant system similar to the EU.
  • Asia

    India
  • Regulatory Body: Central Drugs Standard Control Organization (CDSCO)
  • Regulations:
  • Medical writing must comply with Schedule Y of the Drugs and Cosmetics Act.
  • Clinical study reports follow ICH E3.
  • China
  • Regulatory Body: National Medical Products Administration (NMPA)
  • Regulations:
  • Regulatory documents must follow Chinese Pharmacopoeia Standards.
  • Clinical trial protocols and reports align with ICH guidelines.
  • Japan
  • Regulatory Body: Pharmaceuticals and Medical Devices Agency (PMDA)
  • Regulations:
  • Adherence to Japanese Pharmaceutical Affairs Law and ICH E3 guidelines.
  • Middle East

    Saudi Arabia
  • Regulatory Body: Saudi Food and Drug Authority (SFDA)
  • Regulations:
  • CTD format for drug approval dossiers.
  • United Arab Emirates
  • Regulatory Body: Ministry of Health and Prevention (MOHAP)
  • Regulations:
  • ICH guidelines.
  • Africa

    South Africa
  • Regulatory Body: South African Health Products Regulatory Authority (SAHPRA)
  • Regulations:
  • ICH E3 and E2 standards.
  • Nigeria
  • Regulatory Body: National Agency for Food and Drug Administration and Control
  • NAFDAC
  • Regulations:
  • NAFDAC Drug Submission Guidelines.
  • Global Medical Writing/Scientific WritingSalaries

    Salaries for Medical Writing/Scientific Writing professionals vary globally based on experience, type of employer (pharmaceutical companies, CROs, or agencies), and geographic region. Below is a general breakdown:

    North America

    USA
  • Entry-level: $60,000-$80,000/year
  • Mid-level: $85,000-$120,000/year
  • Senior-level: $125,000-$160,000/year
  • Canada
  • Entry-level: CAD 55,000-CAD 75,000/year
  • Mid-level: CAD 80,000-CAD 100,000/year
  • Senior-level: CAD 110,000-CAD 140,000/year
  • Europe

    United Kingdom
  • Entry-level:   28,000-  40,000/year
  • Mid-level:   45,000-  65,000/year
  • Senior-level:   70,000-  100,000/year
  • Germany/Netherlands/France
  • Entry-level:   35,000-  50,000/year
  • Mid-level:   55,000-  75,000/year
  • Senior-level:   80,000-  120,000/year
  • Asia-Pacific

    India
  • Entry-level:   4,00,000-  8,00,000/year
  • Mid-level:   10,00,000-  18,00,000/year
  • Senior-level:   20,00,000-  30,00,000/year
  • Japan
  • Entry-level:   4,000,000-  6,000,000/year
  • Mid-level:   7,000,000-  10,000,000/year
  • Senior-level:   11,000,000-  15,000,000/year
  • Australia
  • Entry-level: AUD 60,000-AUD 80,000/year
  • Mid-level: AUD 90,000-AUD 120,000/year
  • Senior-level: AUD 130,000-AUD 180,000/year
  • Middle East

    UAE
  • Entry-level: AED 150,000-AED 200,000/year
  • Mid-level: AED 220,000-AED 300,000/year
  • Senior-level: AED 350,000-AED 500,000/year
  • Saudi Arabia
  • Entry-level: SAR 120,000-SAR 180,000/year
  • Mid-level: SAR 200,000-SAR 300,000/year
  • Senior-level: SAR 350,000-SAR 500,000/year
  • Africa

    South Africa
  • Entry-level: ZAR 250,000-ZAR 400,000/year
  • Mid-level: ZAR 450,000-ZAR 700,000/year
  • Senior-level: ZAR 750,000-ZAR 1,200,000/year
  • Nigeria/Kenya/Ghana
  • Entry-level: $10,000-$20,000/year
  • Mid-level: $25,000-$40,000/year
  • Senior-level: $45,000-$75,000/year