Scientific Writer Publications
Our client, a global pharmaceutical organisation are currently recruiting for a Scientific Writer Publications to join their growing Global Scientific Communications team. As Scientific Writer Publications, you will work with cross-functional, multidisciplinary teams to prepare scientific publications including abstracts, posters, manuscripts and presentations and/or regulatory documents such as protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications.
Responsibilities
* Document Preparation, Development and Finalization/Document Management
* Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions
* Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review and coordinate the publication of scientific data in peer-reviewed journals and forums and/or regulatory documents supporting clinical development/product registration
* Conduct effective document initiation to ensure authoring team alignment and understanding
* Assist in building persuasive and scientific-based arguments 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, strategically aligned scientific narrative, elements from internal guidance and resource documents are included appropriately in all documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data
* Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version
* Exhibit flexibility in moving across development and preparation of multiple document types
* Work with teams to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion
* Influence or negotiate change of timelines and content with other team members
* Advocate internally and externally for appropriate authorship criteria on all applicable work products
* Work with internal and external speakers to develop and prepare presentations
* Build and manage relationships with vendors/alliance partners
* Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management
* May participate in in-licensing and co-development activities, including ensuring the quality of data in documents
* Support the implementation of the outsourcing strategy by effectively partnering with staff, the management team, outsourcing team, technical lead consultants, and vendor staff.
Requirements
* Bachelor’s degree in scientific, health, communications, or technology related field or, Bachelor’s degree in any field with at least two years of clinical development experience
* Demonstrated experience of verbal and written English skills in the medical, scientific or technical Writing fields
* Experience writing regulatory, clinical trial documents and/or publications
* Experience in clinical development, clinical trial process or regulatory activities
* Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Demonstrated project management and time management skills.
* Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets)
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