Bhulan Kumar Singh

Manager-medical Writing, Global Clinical Research Operation @Glenmark Pharmaceuticals

Navi Mumbai, IN

Coordinate among team members and cross-functional and cross-geographic teams within organization• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary• Develop, implement, and manage templates and documentation format required for standardization of regulatory and clinical documentation as per SOPs• Perform literature searches/reviews as necessary to obtain background information for development of documents• Preparation, editing, and review of clinical trial documents like clinical trial protocol, CSR, protocol synopsis, IB, clinical and nonclinical summaries, safety narratives, ICF, CRF, SAP, RMP, and other medical documents• Prepration and review of IND/NDA and eCTD dossiers• Preparation and review of medical writing SOPs,• Technical and medical support to clinical operations, DM, and Biostatistics team• Clinical trial registration including preparation and review of clinical trial registration data sets in coordination with the protocol authors and registration of the trials on CTRI and clinical trial governance• Preparation and review of clinical trials disclosure datasets, and manage posting within timelines • Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide and poster presentations• Knowledge and working in accordance with Good Clinical Practices, ICH guidelines, and SOPs

Hamdard University

Ph.D

Hamdard University

M.Pharm.