Document Level Publishing
Let me ensure your critical documents are perfectly submission-ready, adhering precisely to all regulatory agency specifications. I offer this specialized service for content I've drafted, as well as for your existing documents.
My detailed document-level publishing includes:
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Precision Word Formatting: Applying meticulous attention to styles, cross-references, tables, and pagination for optimal presentation and flawless PDF conversion.
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Robust PDF Processing: Comprehensive QC of all bookmarks, internal and external links, and document properties, guaranteeing your files meet every technical and regulatory requirement.
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Seamless eCTD Integration Support: Preparing your documents for smooth inclusion within eCTD modules.
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Navigational Enhancements: Creating comprehensive internal and external hyperlinking for easy review and compliance verification.
Expert Collaboration
Collaboration is at the heart of how I approach not only non-clinical writing, but all writing. I work seamlessly within teams to offer a wide spectrum of services.
Some of my expertise includes:
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Project Management: Carefully deploying necessary resources and managing complex timelines with others
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Quality Control and Editorial: Ensuring the final document delivery is the highest possible quality
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Document Pre-publishing: Aligning the final product with expected submission standards
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Medical Review: Consulting on the medical and scientific accuracy and appropriateness of data and study design
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Other writers/specialists to optimize project efficiency
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Publications and Medical Affairs
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Graphic Planning & Design
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Clinical Trial Disclosure and Redaction
Why are medical writers important?
Deeper Knowledge
Medical writers play a crucial role, from breaking down complex scientific research for regulatory agencies to helping biopharma and health companies engage their audiences. As a physician, I offer a unique clinical perspective, ensuring your content not only meets these standards but also deeply understands and reflects the realities of patient care and medical practice.
Faster Time-To-Write
While no one possesses universal knowledge, medical writers - especially physician writers - excel at rapidly assimilating new therapeutic areas, complex concepts, and specialized terminology. In the fast-paced biopharmaceutical and medical device industries, this agility is invaluable, empowering companies to remain at the forefront of innovation.
Multiple Skillsets
Beyond core scientific knowledge, writing proficiency, and project management, a highly effective medical writer often possesses a unique skill that enhances outcomes—be it biostatistics expertise or specialized publication management. For your projects, I add to this foundation with my unique physician's perspective, proven statistical analysis acumen, and a strategic understanding of digital content, copywriting, and SEO to maximize your impact.