Medical Writer

Summary:

The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical writers.

Project Details:

• Author or coordinate the authoring of the following Clinical Documents: Study Protocols, Clinical Study Reports, Clinical Study Summaries (for posting to study registries)
• Author or coordinate the authoring of the following Regulatory Documents:
• Common Technical document (CTD) clinical and nonclinical sections for IND, NDA and MAA documents
• Briefing Documents for Regulatory Interactions, e.g., FDA Meetings, EMA
• Scientific Advice
• Responses to Regulatory Agency questions Author or coordinate the authoring of the following multidisciplinary documents: Investigator Brochure
• Orphan Drug Designation Requests
• Manuscripts and posters, including support for primary author, writing or coordinating first drafts, managing internal and external reviews and journal submission
• Manage external medical writing resources
• Organize Framework Meetings prior to the initiation of key clinical or regulatory documents to ensure alignment on essential insights and scope
• Coordinate the review and quality check of all documents
• Work with Clinical Development, Biostatistics, Safety, Regulatory Affairs and Project Management to ensure document preparation timelines are consistent with Program goals

Job Experience:

• Five or more years experience in Medical Writing in the Biopharmaceutical industry, with experience supporting NDA filings
• Regulatory writing experience is preferred
• Ability to work without close supervision
• Direct management experience or experience coordinating external resources
• Excellent written and verbal communication skills
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
• Ability to multi-task and complete assignments on time
• Excellent problem-solving capabilities and organizational skills
• Knowledge of medical, pharmaceutical, and clinical research concepts
• A high degree of familiarity with statistical and data output
• Expert level skills in relevant computer software including Microsoft Word, and familiarity with bibliographic citation tools and software
• Knowledge of the methods, techniques, and procedures of medical writing tasks
• Prior clinical protocol and CSR writing experience
• Prior experience with documents for submissions in electronic Common Technical Document (eCTD) format.
• Detailed and experienced-based understanding of applicable regulations, and the CTD structure.

Hourly Rate: 27.625-35.75