Ganesh R. Manjeri, PhD

Clinical Research & Development Lead (on secondment) at GlaxoSmithKline Vaccines, involved in clinical development of Phase 1/2 studies Senior Scientific Writer at GlaxoSmithKline Vaccines, supporting Phase 1 to Phase 3 and life cycle management studies. Experience and Expertise: Regulatory Writing - Submissions to Regulatory Authorities - IND (FDA), Scientific Advice (EMA), Response to Questions (RTQ) to global regulatory agencies. Clinical Documents for Regulatory Submissions (Vaccine's): Clinical Study Protocols, Investigators Brochure, Clinical Study Reports for Clinical (Interventional) and Epidemiological studies (Observational i.e. Database, Burden of Disease), Plain Language Summaries. Other Clinical Document(s): Clinical and Epidemiological Development Plans. Medical Communication (Oncology) - Standard Responses, Slide-sets for Internal and External Medical knowledge sharing, Pivot charts to assess content usage on priority brands. PhD in Mitochondrial Medicine from the labs of Prof. Jan Smeitink and Dr. Peter Willems at Radboud University Nijmegen, The Netherlands.