Exciting Opportunity for a Medical Writer at Clini Launch Research Institute
Exciting Opportunity for a Medical Writer at Clini Launch Research Institute
Location: Hinjewadi Phase 3, Pune
Organization Overview:
Clini Launch Research Institute (CLRI) is an advanced clinical research institute and professional training center dedicated to bridging the gap between aspiring professionals and the industry. Our mission is to empower graduates in Pharmacy, Life Sciences, Medicine, and Paramedical fields, equipping them with the skills needed for success in the clinical research industry. Through extensive industry partnerships and connections, we provide career opportunities that bring fulfillment and growth to deserving candidates. CLRI has pioneered clinical research programs, with numerous students completing our programs—making us the leading institute with the highest number of graduates ready for impactful careers in clinical research.
Qualifications Required:
Bachelor’s in Pharmacy (B-Pharm) or Master’s in Pharmacy (M-Pharm)
Relevant clinical experience in clinical research, especially with Bioequivalence and Bio-Availability (BA/BE) studies
Experience level: 2-5 years
As a Medical Writer at Clini Launch Research Institute, you’ll play a crucial role in the preparation and submission of various clinical research documents for regulatory bodies. Your work will directly impact the quality and effectiveness of clinical research documentation, ensuring it meets regulatory standards across major agencies such as the DCGI, USFDA, EMA, ANVISA, CDSCO, TGA, and Canada’s regulatory bodies.
Key Responsibilities ✍️
1. Development of BA/BE Study Protocols:
You will be responsible for creating detailed study protocols specifically for Bioequivalence and Bio-Availability (BA/BE) studies. These protocols need to comply with ICH-GCP guidelines, ensuring all documentation meets global standards. Your protocols will be integral for various regulatory submissions, showcasing the credibility and preparedness of the institute's studies.
2. Clinical Trial Protocol Preparation (Phase III and IV):
Drafting clinical trial protocols, especially for Phase III and Phase IV trials, will be another significant responsibility. This includes setting guidelines for research methodology, data collection, analysis, and reporting to meet the scientific rigor and ethical standards required by regulatory bodies.
3. Creation of Investigator Brochures:
The Investigator Brochure (IB) is a critical document providing essential information to researchers about the trial's design, benefits, and potential risks. Your role involves preparing these brochures to facilitate a clear understanding of the study's scope and requirements.
4. Study Synopsis and Feasibility Documentation:
As part of study planning, you will prepare feasibility and study synopses that summarize the key points and feasibility of the study. These documents are vital for initial approval stages and help streamline the process of gaining stakeholder alignment.
5. Informed Consent and Case Report Forms (ICF/CRF):
Developing ICF and CRF based on the protocol study design is essential to ensure ethical standards and patient safety. Your work in drafting these documents will help ensure participants understand their rights, risks, and benefits of taking part in the research.
6. Protocol Amendments and Safety-Related Documents:
You will be responsible for preparing protocol amendments, amendment reports, lists of changes, and other safety-related documents if needed. This includes any molecule-specific changes, adjusting protocols based on emerging data or safety concerns.
7. Clinical Study Reports (CSR):
The preparation of CSRs in compliance with ICH-GCP is a significant part of this role. These reports will summarize the findings from the clinical studies, which are essential for regulatory submission and ensure the data's integrity and reliability.
8. Clinical and Non-Clinical Overviews:
You’ll also work on preparing clinical and non-clinical overviews that provide a summary of relevant scientific data, supporting documentation for the product's safety and efficacy.
9. DBE Summary Table Preparation:
Developing DBE summary tables for regulatory submission is another core responsibility. These summaries provide concise and clear data for regulatory review, assisting in the process of obtaining regulatory approval for the studies.
10. Review of Outsourced Documents:
In cases where certain documents, like BA/BE protocols, ICFs, and CSRs, are outsourced, you’ll review these to ensure they meet the required standards and are in compliance with the regulatory requirements.
This role requires attention to detail, a solid understanding of regulatory standards, and strong communication skills. If you’re a medical writer with expertise in clinical research, especially in BA/BE studies, Clini Launch Research Institute would love to hear from you.
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