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Scientific Writer - Publications
Our client, a global pharmaceutical organization, is 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 scientifically-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, management, outsourcing teams, technical lead consultants, and vendors.
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 the 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)
For more information, please contact Sinéad Cullen at +353879500821 or
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