Scientific Medical Writer

Shri Kartikeya Pharma; Hyderabad; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Shri Kartikeya Pharma in Hyderabad, India, seeks a Scientific Medical Writer to create clear, accurate, and regulatory-compliant scientific content for research, manuscripts, and regulatory needs.

Responsibilities include literature reviews, study synopses, protocol development, drafting manuscripts per ICMJE/ GPP4/ CONSORT, and end-to-end manuscript coordination with CROs and investigators. Excellent English writing is essential.

Formación

• Masters with research experience in relevant life sciences.
• Fresh PhD acceptable.
• Experience in clinical trial data analysis.
• Excellent scientific writing in English.
• Knowledge of ICH-GCP and DCGI regulations.

Responsabilidades

• Conduct literature searches in PubMed, EMBASE, SCOPUS.
• Prepare study synopses and regulatory-compliant protocols.
• Draft manuscripts per ICMJE, GPP4, and CONSORT guidelines.
• Coordinate manuscript submission and publication process.
• Collaborate with CROs and investigators.
• Prepare high-quality scientific content for product brochures.

Conocimientos

Medical writing

Clinical research

Regulatory guidelines

English writing

EndNote

Prism

Educación

Master's degree in biology/biochemistry/pharmacology

PhD (fresh) in science

Herramientas

Microsoft Word

Excel

PowerPoint

EndNote

Prism

Descripción del empleo

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. Fresh Ph.D.'s with Science background also can apply.

Skills Required:

• 3-5 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