Responsibilities for medical writer Knowledgeable of US and international regulations requirements and guidance associated with clinical regulatory document preparation and submissions Understands assimilates and productively interprets sources of information with appropriate guidance direction from product teams and or authors Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers 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 Represents Medical Writing and Clinical Biometrics on cross-functional teams Develops edits and reviews regulatory documents within agreed timelines that have high quality scientific content organization clarity accuracy format and consistency Stays current on medical writing best practices and regulatory guidelines Documenting study-specific Protocol Training Kick-off Meeting Slides Protocol Overview Presentations by filling out and collecting signatures on group training forms as required Write review and edit clinical regulatory documents such as clinical study protocols clinical study reports CSRs Investigator s Brochures and other documents as required for submissions Interpret statistical and clinical data with appropriate guidance direction from teams and management Qualifications for medical writer Advanced Scientific Degree MSc Ph D PharmD Familiarity with medical terminology and clinical trial design theoretical knowledge is sufficient Familiarity with some reference manager software EndNote Reference Manager Mendeley Citavi Excellent time and project management skills team working skills Job Types Full-time Permanent Fresher Pay 28 883 49 - 50 111 00 per month Advantages Health insurance Paid sick time Provident Fund Work Location In person

📌 Medical Writer (Jalgaon)
🏢 Statistical Insights
📍 Jalgaon