Manager Medical Writing

Ixoreal Biomed
location

Full–time

inr null - null /undefined

Purpose: To create clear, accurate, and compliant scientific and medical content that simplifies complex data, manuscripts, supports research and regulatory needs, and effectively communicates information to internal and external stakeholders. KEY DELIVERABLES: • Conduct comprehensive literature searches in PubMed, EMBASE, SCOPUS, and other scientific databases. • Extract, organize, and maintain a structured scientific literature repository. • Develop study synopses and protocols in compliance with regulatory standards for both clinical and preclinical research. • Perform technical review of Clinical Study Reports (CSRs) as per ICH guidelines. • Draft manuscripts in accordance with ICMJE, GPP4, and CONSORT guidelines. • Manage the end-to-end process of manuscript preparation, submission, and publication. • Maintenance of Clinical and preclinical study data repository. • Prepare high-quality scientific and technical content for product brochures and related materials. • Collaborate with Contract Research Organizations (CROs) and investigators to prepare study contracts and support study follow-up activities. • Develop statistical analysis plans and conduct data integrity checks. • Support business development by addressing technical queries and participating in content development. • Resolve technical product-related queries pertaining to business and regulatory requirements. • Participate in client meetings and project-related teleconferences as needed. • Coordinate manufacturing, packaging, and shipment of investigational products for clinical and preclinical studies. Qualifications: Master's degree in a relevant scientific discipline (e.g., biology, biochemistry, pharmacology, medicine), with a strong academic background and research experience. Skills Required: • 8-10 Years of relevant experience from Nutraceuticals Industry Preferred or from a Pharmaceutical (API) Background. • Proficiency in clinical research methodologies and hands-on experience with clinical trial data analysis and interpretation. • Exceptional writing skills with the ability to effectively communicate complex scientific concepts in English, both written and verbal. • Thorough understanding of regulatory guidelines and requirements governing clinical research and manuscript writing, particularly in the Indian regulatory context (e.g., ICH-GCP, DCGI regulations). • Prior experience in medical writing, clinical research, or related fields is advantageous but not mandatory. • Strong organizational skills and ability to manage multiple tasks with meticulous attention to detail and adherence to timelines. • Excellent interpersonal skills and the ability to collaborate effectively with cross-functional teams, clients, and external stakeholders. • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with scientific writing software (e.g., EndNote, Prism). • Commitment to continuous learning and professional development in the field of medical writing and clinical research, including staying updated on developments in the Indian healthcare and regulatory landscape. • Understanding of statistical analysis software commonly used in India and familiarity with data management tools

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Experience - years