Job
Description
Overview of the role: • Responsible for preparation & review of clinical trial documents (Investigators Brochure, Protocol, ICD, CRF) and interpretation of clinical data and other complex information in a most acceptable quality document (Interim Report or Clinical Study Report) • Act as liaison between Scientific affairs team and Clinical Operations study team to provide highest quality Clinical trial documents. • Review and provide the scientific feedback on the essential documents related to conduct of clinical trial. • Write and review scientific abstracts, publication, related to clinical studies. Provide scientific inputs on Healthcare website, health magazine etc. Work closely with multidisciplinary group of experts to translate the study data and results into presentations, reports, regulatory documents, scientific journal manuscripts and abstracts for publication. • Should conduct comprehensive literature searches to enhance background understanding and evaluate and analyze the information. • Regular interaction with KOL in various therapeutic area and discussing on various factors for marketing, product positiong strategy • Interacting with the potential investigators prior to the protocol writing on the design and feasibility of conducting the study • Support in medical affairs activities related to Himalaya products. Provide support to marketing team for responding scientifically to the medical queries raised by the Doctors/ Field staff. Skills Requirement: • Data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills. Good knowledge of English grammar with a familiarity of writing clinical trial documents • Knowledge of global, regional, national and other document development guidelines • Comfort of searching the scientific matter available on open resources. • Ability to communicate scientific or medical information in a clear and concise manner • Should possess good training skills to conduct trainings at various platforms • In order to be effective in job, a Scientific Manager must be aware of current industry practices and regulatory requirements. Must keep abreast of current literature, emerging science, technological developments and medical trends. Role Requirements: • Degree in modern Medicine (MBBS/MD) with 0-3 years of experience OR Degree in alternative medicine (BAMS/ BHMS) OR PhD (Pharmacology) with Medical writing (related to Clinical Trials Document & Publications) experience of at-least 5 years at sponsor or CRO Company is must. • Hands on experience in literature search, targeted literature review, preparation of scientific document, disease or drug related literature on the basis of data available from publications, clinical trials. • Experience in preparation of scientific abstracts, publication would be preferred • Must have thorough knowledge of clinical trial concepts including ICH-GCP, CFR and applicable regulatory guidelines (DCGI, USFDA, MHRA)
