Shama Wagle

Shama is one of tranScrip’s medical writing experts. She has over 25 years of medical writing experience gained while working at tranScrip and on internationally renowned prescribing resources (including the BNF and BNF for Children).

She has experience of writing a wide range of regulatory documents including:

• Clinical trial protocols, CSRs, and IBs for drugs in all Phases of development.
• Briefing books to seek scientific advice from regulators.
• Module 2 documents for regulatory submissions (including NDAs, MAAs, and extensions to approved indications).
• Information for patients (including ICFs/Participant Information Sheets, Lay Summaries).
• Product labels (including company core data sheets, SmPCs).

She has led medical writing projects with a diverse range of pharmaceutical companies and worked flexibly with their different operational systems to meet company requirements. With a sound background in Clinical Pharmacy, Shama has been involved in medical writing across all therapeutic areas.

Shama has spearheaded the establishment of a Regulatory Intelligence platform at tranScrip and leads regular CPD sessions to discuss the implications of new regulatory guidance.

As Lead Editor for BNF Publications, Shama led a team of Clinical Writers to produce the content for the publications in print and digital formats. She worked with a network of clinical experts and expert committees to validate the content. She liaised with educational establishments and healthcare journals to create learning resources using content from the publications. She also advised on the development and implementation of marketing plans for the publications.

Prior to joining the BNF, Shama worked as a Clinical Pharmacist for the NHS where she provided medicines management services across a diverse range of specialities, managed medicines information services and clinical trials, undertook drug usage review studies, and participated in the training and education of healthcare professionals and patients.