Freshers BSc Life Sciences Medical Writer Job at CLINICA Research, Apply on Biotecnika
Job Role: Medical Writer
Company: CLINICA research
Location: Navi Mumbai
Qualification: Bachelor’s degree in life sciences or related field; or equivalent combination of education, training, and experience
Experience: 0–1 year
Salary: ₹20,000 per month
Essential Duties and Responsibilities:
• To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF), Subject Diary, Investigator’s Brochure, Summary of Product Characteristics and other clinical documents as needed.
• Responsible for researching, writing, and editing several types of documents such as abstract, posters, manuscripts, monographs, medical case reports, literature summaries and presentations.
• Summarize data from clinical studies for submission to health authorities, publication in peer-reviewed journals or presentation at professional meetings/conferences.
• Ensure that documents comply with ICH guidelines & regulatory, sponsor/ journal and in-house requirements in terms of structure, contents, and appendices.
• To find various journals for publication of paper written on behalf of sponsor.
• To write scientific papers and white papers as per the requirements of sponsor.
• Contribute towards development of product dossiers for regulatory authority submissions.
• Developing promotional materials and package inserts for products available in the market.
• Provides support
• Assist in Interpretation of clinical, pharmacokinetics, pharmacodynamic and statistical results as appropriate.
• Prepare patient safety narratives and CSR appendices.
• Literature search, systemic review of data and its analysis so as to be up to date with latest breakthrough in the therapeutic area.
• Contribute to planning of data analyses and presentation to be used in CSRs.
• Ensure compliance of documentation to internal company standards and external regulatory guidelines.
• Coordinate in outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer.
• Maintain audit, SOP and training compliance.
• Ensure timely delivery of high quality documents to internal customers and Sponsors.
• Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.
• Act as a client contact for medical writing projects, working with other CLINICA departments and clients to set and meet internal/external deliverable timelines.
• To support BD team in their efforts to win new projects related with medical writing.
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