Senior Medical Writer

Location: Prakāshamnagar

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 Pub Med, 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., End Note, 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.