Qureos Mentor

Statistical Insights

Responsibilities for medical writer<ul><li>Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions</li><li>Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors</li><li>Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers</li><li>Manages all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval</li><li>Represents Medical Writing and Clinical Biometrics on cross-functional teams</li><li>Develops, edits and reviews regulatory documents within agreed timelines that have high quality scientific content, organization, clarity, accuracy, format and consistency</li><li>Stays current on medical writing best practices and regulatory guidelines</li><li>Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, ) by filling out and collecting signatures on group training forms as required</li><li>Write, review, and edit clinical regulatory documents such as clinical study protocols, clinical study reports (CSRs), Investigator&rsquo;s Brochures, and other documents as required for submissions</li><li>Interpret statistical and clinical data with appropriate guidance/direction from teams and management</li></ul>Qualifications for medical writer<ul><li>Advanced Scientific Degree (MSc., Ph.D., PharmD)</li><li>Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient)</li><li>Familiarity with some reference manager software (EndNote, Reference Manager, Mendeley, Citavi)</li><li>Excellent time and project management skills, team working skills</li></ul>Job Types: Full-time, Permanent, FresherPay: ₹28,883.49 - ₹50,111.00 per monthBenefits:<ul><li>Health insurance</li><li>Paid sick time</li><li>Provident Fund</li></ul>Work Location: In person

Medical Writer

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Statistical Insights

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Medical Writer