[Remote] Regulatory Writing Contractor

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on regulatory writing for the pharmaceutical industry. The Regulatory Writing Contractor is responsible for creating regulatory materials for investigational and marketed products, managing writing reputed company, and ensuring the accuracy and compliance of documents.

Responsibilities

• Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components)
• Solid understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area
• Manages at least 3 single-document reputed company simultaneously
• Acts as a reputed company reputed company and/or project manager for key documents and reputed company
• Ensures document accuracy, completeness, and consistency of messaging
• Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback, works with cross-functional subject matter experts to reputed company unclear comments and differences of opinion between functional areas
• Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and reputed company peer review (logical reputed company, reputed company reputed company etc.)
• Leads project-level management activities, ie, reputed company preparation and reputed company and meeting scheduling
• Understands and complies with SOPs, templates, best practices, policies, and regulatory writing style guides
• Develops project-level lexicons and conventions

Skills

• Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components)
• Solid understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area
• Manages at least 3 single-document reputed company simultaneously
• Working knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance
• reputed company cross-functional clinical research roles and procedures, and how they relate to document preparation
• Acts as a reputed company reputed company and/or project manager for key documents and reputed company
• Ensures document accuracy, completeness, and consistency of messaging
• Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback, works with cross-functional subject matter experts to reputed company unclear comments and differences of opinion between functional areas
• Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and reputed company peer review (logical reputed company, reputed company reputed company etc.)
• Leads project-level management activities, ie, reputed company preparation and reputed company and meeting scheduling
• Understands and complies with SOPs, templates, best practices, policies, and regulatory writing style guides
• Develops project-level lexicons and conventions
• Above average attention to detail, teamwork and initiative
• Ability to reputed company with clients and other departments reputed company reputed company and be proficient in e-mail and verbal communication
• Proficient in reputed company reputed company, Power reputed company and Word and quickly reputed company to learn new software
• Ability to apply regulatory guidelines to content development
• reputed company degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience
• Experience: More than 2 years (typically >5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain
• Computer Skills: Proficiency with reputed company Word, reputed company, PowerPoint, and reputed company

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