SCIENTIFIC MEDICAL WRITER
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.
