Himalaya began its journey at a time when herbal products were regarded with skepticism. But, our founder persevered to follow his dreams. Pawning his mother's bangles, he bought a hand-operated tableting machine.
Post : Lead Scientist : Medical Writing
Job Description
• Responsible for preparation and review of clinical trial documents (Investigators Brochure, Protocol, ICD) in accordance with documented guidelines, SOPs within stipulated timelines.
• Effectively accomplish the medical writing activities & build expertise across the different document types assigned.
• Interpretation of clinical data and other related information in a most acceptable quality document (Interim Report or Clinical Study Report)
• Co-ordinate and maintain an effective relationship with Scientific Strategy and Medical writing team and Clinical Operations study team to provide high quality Clinical trial documents.
• Provide the scientific feedback on the essential documents related to conduct of clinical trial.
• Write 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 analyse the information.
Candidate Profile
• M.Pharm / MSc / Pharm.D / BDS / PhD (Pharmacology) or degree in alternative medicine (BAMS/ BHMS) with 5 years experience in Medical writing (related to Clinical Trials Document & Publications).
• Hands on experience in literature search, targeted literature review, preparation of scientific document, disease or drug related literature based on data available from publications, clinical trials.
• Experience in preparation of scientific abstracts, publication would be preferred
• Desirable to have thorough knowledge of clinical trial concepts including ICH-GCP, CFR and applicable regulatory guidelines (DCGI, USFDA, MHRA)
• Medical writing skills, including grammatical, editorial, and proofreading skills.
• Good knowledge of English grammar with a familiarity of writing clinical trial documents
• Familiarity with the principles of clinical research
• Knowledge of global, regional, national and other document development guidelines
• Comfort of searching the scientific information available on open resources.
• Ability to communicate scientific or medical information in a clear and concise manner
• Must be aware of current industry practices and regulatory requirements.
• Must keep abreast of current literature, emerging science, technological developments and medical trends.
Additional Information
Experience : 5 to 8 year
Qualification : M.Pharm / MSc / Pharm.D / BDS / PhD
Location : Bangalore / Bengaluru
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Medical Writing
End Date : 10th December, 2021
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