Scientific Lead - Clinical Development, Safety & Publications

Scientific Lead-Clinical Development/ Safety/ Publications

Overview of the role

• Responsible for development of clinical trial documents (Investigator’s Brochure, Protocol, ICD) and interpretation of clinical data and other complex information in a most acceptable quality document (Interim Report or Clinical Study Report).
• Ensure and coordinate for scientific abstracts & publication related to clinical studies (inhouse or through external agency). 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.
• Act as liaison between Scientific affairs team and Clinical Operations study team to provide the scientific feedback for development of high quality Clinical trial documents.
• Expertise in comprehensive literature searches on medical domain to enhance background understanding,  and evaluate and analyze the information.
• Should be able to respond scientific/ medical queries raised by the various R & D functional groups/ Doctors/ Field staff.
• Should be able to coordinate with internal/ external team (CRO) for managing safety/ pharmacovigilance for the organization (g

Skills Requirement:

• Medical writing skills, including grammatical, editorial, and proofreading skills. Good knowledge of English grammar with a familiarity and expertise of writing clinical trial documents.
• Thorough knowledge of data interpretation and manuscript writing, selection of journals till publication in highly indexed global journals.
• Knowledge of global, regional, national and other document development guidelines (ICH-GCP, CFR) and applicable regulatory guidelines (DCGI, USFDA, MHRA) for clinical research.
• Comfort of searching the scientific materials available on open resources related to therapeutic guidelines and clinical validation.
• Ability to communicate scientific or medical information in a clear and concise manner at department/ organization/ external scientific forum.

Role Requirements (Qualification & Experience):

• Degree in Modern Medicine ;MBBS in the range of 8-10 years of relevant experience or MD in the range of 5-7 years of relevant experience (with industry/ CRO/ Service organization is must).