#1, Radial Road, Pallikaranai, Chennai – 600 100, Tamil Nadu, India
Responsibilities: ✓ Develop different types of medical education & communication programs/deliverables such as: • Training manuals/ slides • Review articles • Product monographs • CME slide decks • Newsletters • Case reports • Brand promotional deliverables • Patient education deliverables • International speaker summaries ✓ Review medical reports, scientific information, medical terminologies and documents ✓ Conduct content search, editing, storyboard creation for multimedia deliverables such as interactive CDs, patient education films, e-detailing films, websites, and animations ✓ Develop and maintain necessary templates, formats, and styles to ensure that documents generated meet industry, regulatory, internal, and client requirements ✓ Carry out primary proofing of documents/ files ✓ Ensure delivery of projects/ tasks within the given/ agreed timelines ✓ Ensure adherence to processes, scientific code of conduct (reference-backed writing) and ethics of writing (no plagiarism) Requirement: ✓ Knowledge in any of the medical and allied fields ✓ In-depth knowledge of various therapeutic areas ✓ Knowledge of relevant guidelines related to structure and contents of specific document with good understanding of Vancouver style of referencing ✓ Familiar with searching medical literature databases such as PubMed, Research Gate etc. ✓ Clear, concise, scientific style of writing with a high level of attention to detail ✓ Good computer literacy and a familiarity with Microsoft Office applications Duties and Responsibilities: ✓ At least 3 years of medical writing experience, preferably within a medical communication agency writing environment ✓ Use scientific expertise to develop high-quality, publication-ready scientific documents (manuscripts, posters, abstracts, short communications, presentations, etc.) ✓ Understanding & analyzing market needs as well as understanding the USPs of product and developing content to suit brand/therapy strategy ✓ Collaborate with campaign manager and creative team to develop the content as per brand campaign requirement for promotional content ✓ Act as a writing specialist, provide intellectual input across document types, and contribute to making cutting-edge research accessible to specific audiences ✓ Excellent content development, content editing, and proof-reading skills ✓ Excellent command of English with reasonable creative writing skills Pediatric Study Plan (PSP) ✓ An Initial PSP is an outline of the paediatric study or studies that the drug development sponsor plans to conduct in the USA to confirm the suitability of drug usage in the paediatric population. ✓ Initial PSPs cover study objectives and design, age groups, relevant endpoints and statistical approach. Amended PSPs follow. ✓ The preparation of a PSP requires concise presentation of information about the disease to be treated in children, as well as laying out all relevant current knowledge of the drug being developed, assembling a convincing rationale for the paediatric study plan proposed. ✓ Trilogy staff have accumulated extensive experience in the preparation of plans covering a range of paediatric therapeutic areas. Common Technical Document (CTD) ✓ The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module 1 Administrative information and prescribing information; Module 2 Overviews and summaries of Modules 35; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers.