Clin Infotech

Teacher Name

35 Days

Advance Medical Writing Certification Course

Clininfotech provides professional Medical Writing Course with Experience Trainers Who has vast Experience in Medical Writing Department in Multi Tier  pharmaceutical, biotechnology Companies  via individual subject matter experts or full delivery teams, working either onsite or offsite to support medical writing activities. Our medical writers are experienced in various therapeutic areas across all phases of development.

Pharmacy, Life Sciences, Dental BDS and Medical Graduates and Phd In Life Sciences are the Best Suitable Candidates for Medical Writing Course.

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use, and other medical information. The medical writer also ensures that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.

  • Submission Project Management
  • Regulatory Submission Dossiers (NDA, sNDA, ANDA, BLA, MAA, 505(2)(b))
  • Investigational New Drug Applications
  • Aggregate Reports (Investigators Brochures, Risk Profiles, Annual Reports)
  • Study Protocol Preparation
  • Clinical Study Reports
  • Medical Information and Post-Marketing Writing
  • Research Paper Publication, Posters, Manuscripts, Presentations, and Abstracts

Professionals who can consider Clinical Research Career as a next logical move to enhance in their careers include:

  • Pharmacy Professionals ( B.Pharamcy / M.Pharamacy / Pharm D)  from any domain who has Good analytical skills
  • Medical Professionals (MBBS / BDS/ BPT/ BHMS/BAMS/ Nursing) Freshers / Experience Professionals.
  • sc / M.Sc ( Biotech/ Microbiology/ Biochemisty/ Chemistry & All Life Sciences) Freshers / Expereince
  • Software programmers
  • Business analysts
  • Six Sigma consultants
  • Fresher from any Science stream with good Analytical and logical skills

The focus of the lectures is mainly on:

  • Introduction To Scientific/ Medical Writing
  • Fundamentals Of Good Medical Writing Practices
  • Overview Of The Regulatory, Marketing And Drug Promotion Processes
  • Prerequisites Of Medical Writing And Qualities To Become A Medical Writer
  • Different Documents And The Requirements In Medical Writing
  • SOP, Protocol, IB, CRF, Patient Information Sheet/SPC And Patient Informed Consent Form
  • Educational Medical Writing (Including PIS, ICF, Marketing Materials, Sales Training Manual, Conference Materials, Brochures, Etc.)
  • Regulatory Medical Writing And Different Documents Submitted To Regulatory Authority
  • IND, NDA, PSUR, DSUR, CSR, Etc
  • Development Of Writing Skills In Educational And Regulatory
  • Writing Flow And Cohesiveness
  • Publication Writing
  • Documents In Medico-Marketing
  • Managing The Review Process Different Specialities In Medical Writing
  • Consumer Health Writing (Information To Patients)
  • Technical Communication
  • Policy Writing And Grant Writing
  • Medical Writing For Academia And Hospitals
  • Regulations And Industry Standards
  • Writing Standard Operating Procedures Policies, Procedures, Instructions
  • Writing & Organizing A Scientific Journal Article
  • Preparing Scientific Abstracts And Posters
  • Introduction to Scientific/ Medical writing
  • Publication writing
  • Branding and commercial writing
  • Narrative Writing
  • Introduction to regulatory writing
  • Source Documents in Clinical Research
  • Documents in Medico Marketing
  • Protocol writing
  • PAPER CRF Preparation
  • Investigator Brochure (IB) preparation & Subject Diary Card Preparation
  • Clinical Study Reports (CSR)
  • Common Technical Document (CTD/eCTD) preparation
  • Dossier submissions (IND/NDA/ANDA)
  • ICD translations
  • Handling Statistics in Medical Writing
  • Effective Literature Search
  • Legal/ Copyright Issues in Medical Writing

Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. You can Join Regulatory or Commercial Medical writing team in Pharma Companies or CROs or KPOs.

  • Complete Course Material will be provided including detailed information about the entire work flow of Medical Writers.
  • Internship available after rigorous training in Medical Writing.
  • Own CRO live Projects
  • We Provide Real Time Experience on Scientific Writing for Research Scholars.
  • Highest Placement record across all training institutes
  • Industry based SOP’s  training
  • Trainers with minimum of 7+ years of experience
  • Comprehensive teaching by Medical Doctors
  • Total 150 hours of exposure to theory, case studies and practicals.
  • Practical Hands on Training will be provided on Journal Publishing, Protocol Preparation, CRF Designing, Subject Diary Card preparation & CSR Writing

Clinifotech Provides Certificate  for Medical Writing  Course on successful completion of Assignments & Projects. As Part of Medical Writing Training . The Certificate would be awarded at the end of the program by Clininfotech. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.