Competencies and Skills Required in Medical Writing
Dr. Deepti Sanghavi is a physician by qualification and has a total of 15 years of experience in clinical research (that includes 7 years of project management and 8 years of medical writing). She has managed trials for different phases and therapeutic indications. Her expertise lies in her problem-solving approach, managing regulatory/clinical/safety document projects (both draft and review), training, and mentoring. She has presented on various clinical research topics across the globe (Germany, Austria, Spain, Shanghai, Malaysia, Florida etc.) in international conferences and investigator meetings and also nationally in India. She is a visiting faculty in various institutes in Mumbai. In her previous role, she was a product lead and worked for Roche Pharma client. Since a few months, she has started working as a consultant and subject matter expert. She conducts personalized training courses and workshops in clinical research and medical writing.
This webinar will provide an essential overview of the scope of medical writers with respect to regulatory, safety, and scientific writing. The presenter will discuss in detail the general and specific competencies and skills required for a medical writer to be successful in his/her career. Some of the competencies, knowledge, and skill required and how they help in everyday life -that will be discussed are
- Through an understanding of the drug development process
- Detailed knowledge about GCP
- Clinical research process from each stakeholder perspective
- Overview of the regulatory process, including key regulations and guidance documents, remaining updated on the same
- Advanced knowledge about Microsoft Word
- Useful websites and links
- Self-driven and motivated
- and many others………
Medical writers work in close association with many different stakeholders in pharmaceutical organizations (i.e., Sponsors) and CROs to create specialized documents to serve regulatory, safety, scientific niche areas.
- Overview of the knowledge
- Skills required for any medical writer
Course Level - Basic/Intermediate
Who Should Attend
- Anyone involved in medical and scientific writing
- Anyone wanting to build their career in medical writing
- Existing writers in the industry who want to go ahead in their career and perform/ improve their performance in the job
- Potential writers or freshers who want to enter the medical writing industry
Why Should Attend
There is an increased demand for well-written documents that are compliant to scientific requirements, adhering to regulations, standard operating procedures, templates, formats, style guides etc. while not deviating from proper language use and ethics. We will discuss in detail about the same that will help the potential and existing writers to enhance and improve their knowledge and skills.