Job Description

EMS (Executive Medical Summary) - Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management - Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. - Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. - Conduct effective document initiation meeting to ensure authoring team alignment and understanding. - Build scientific-based rationale that support the purpose of more complex and/or strategic documents. - Ensure data are presented in a clear, complete, accurate, and concise manner. - Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. - Coordinate expert/scientific reviews, collate reviewer\'s comments, adjust content of document as required based on internal/external input, and prepare final version. - Ensure and coordinate quality checks for accuracy. - Exhibit flexibility in moving across development and preparation of multiple document types. - Influence or negotiate change of timelines and content with other team members. - Work with internal and external experts to develop and prepare presentations. - As needed, may build and manage relationships with vendors/alliance partners. - Project and Stakeholder management - Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. - Build/communicate credible writing project timelines. - Anticipate and mitigate risks to delivery - Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. - Effectively communicate project status to stakeholders - Knowledge and Skills Development - Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). - Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. - Maintain and enhance knowledge of regulatory guidelines and publication guidelines. - Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. - Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. - Knowledge Sharing - Provide coaching to others by sharing technical information, giving guidance, answering questions. - - Recognized for technical expertise in specific document development. - Network with others (including other functions and regions) to identify and share best practices. - Contribute to process improvements, suggesting opportunities where appropriate. - Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: - Bachelor\'s degree in a scientific, health, communications, technology health related field. - Demonstrated experience in technical/ regulatory scientific writing. - Strong communication and interpersonal skills. - Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process) (ref:biojoby.com)

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