Proficient in developing high-quality key clinical trial documents, including protocols, Investigator&aposs Brochures (IBs)
Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs).
Proficient in translating complex scientific data into clear, regulatory compliant documents that support drug development and approval processes.
Additionally, experienced in crafting abstracts and manuscripts, demonstrating strong scientific communication skills.
Committed to delivering high-quality, accurate, and well-structured documents that contribute to the success of clinical research and regulatory submissions.
Preparation of protocols, CSRs, PIS-ICFs and CRFs.
Understanding the study objectives and designing the protocol.
Preparation and review of SOPs.
Communicating with all stakeholders to ensure effective and complete documentation within the timeline.
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Skills Required
Protocols
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Medical Writer • Bengaluru / Bangalore, India
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