Gratisol Labs Exclusive Medical Writing Training Program
Gratisol Labs Medical Writing team provides professional writing services and quality reviews to the pharmaceutical, biotechnology, and medical device industries 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.
Medical writing is essential for the analysis and interpretation of the data as per the requirement of the organization, and also to provide information and knowledge to various populations, particularly the researchers. Medical writing simplifies a complex idea for a group of mixed population. A well-written clinical study report proves to be of great importance in the production of high quality subsequent documents (eg, CTDs). Inappropriately written or compiled regulatory documents lead to delays in regulatory approval, which may result in the loss of money for the sponsor
Medical writing requires an understanding in medical science and good writing skills; we can define medical writing as a science and an art. Adequate knowledge of specific regulatory requirements/guidelines for different types of documents is required. In the current scenario, wherein the bio-pharma industry is looking to cut costs, medical writers are very much in demand. Hence graduates and post-graduates in life sciences and pharmacy who have the right writing skills and talent can consider medical writing as a full-time profession.
Gratisol Labs Medical Writing services include:
- 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
ADVANCED CERTIFIED PROGRAM IN MEDICAL WRITING
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.
Following Course Content will be covered during the training:
A very good opportunity for Science, Medicine & Pharmacy Graduates.
If your Basic English is good & you are well versed with medical terminologies, this is one of the fastest growing Service Industry in India.
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.
To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:
Screening And Selection Of Students
GRATISOL LABS ADVANTAGE:
- Complete Course Material will be provided including detailed information about the entire work flow of Medical Writers.
- 2 months 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
OUR TEAM OF EXPERIENCED MEDICAL WRITERS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:
- Resume Preparation
- Interview Preparation with real time questions and answers
- Mock Interview Sessions
- Communication Skills and Personality development Sessions
- Placement Assistance
- Placement Assurance
Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.
For more information, please contact Gratisol Labs at firstname.lastname@example.org