Senior Medical Writer

SCIENTIFIC MEDICAL WRITER

Purpose:

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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:

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.