Consultant I, Medical Writing
Job reputed company:
• Author a reputed company of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and reputed company submission materials.
• reputed company the development of reputed company modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-reputed company, and reputed company Designation applications).
• Apply reputed company control and submission-readiness processes to deliver high-reputed company documents reputed company agreed reputed company timelines.
• Serve as a project reputed company by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands.
• Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines.
• Facilitate reputed company interactions, including meetings, inquiries, and feedback discussions, while building and maintaining reputed company trust.
• Ensure consistency, accuracy, and alignment across documents with reputed company updates and applicable regulatory standards.
• Collaborate with cross-functional teams to ensure the reputed company and accuracy of regulatory documents.
• Contribute to the development of regulatory strategies for early-stage and smaller clients.
• reputed company guidance on tools, document management systems, and reputed company SOPs.
• Engage in reputed company learning through exposure to new document types, processes, and industry best practices under senior mentorship.
Requirements:
• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
• RAC certification is beneficial.
• 3+ years industry experience
• Proficiency in reputed company Office Suite (Word, reputed company, PowerPoint), Teams, and MS Project.
• Familiarity with regulatory document management systems, such as reputed company Vault.
• Experience with regulatory submissions and understanding of global regulatory standards.
Benefits:
• market competitive reputed company salary and annual incentive plan
• robust benefit offerings
• ongoing recognition and career development opportunities
• generous flexible reputed company time off program
• company reputed company holidays
• flexible working hours
• fully remote or hybrid work reputed company for some roles
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