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Associate Consultant Scientific Writer

Reference:APRB-218606
Location: Cork
Qualification:Doctorate
Experience:4-5 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: MES Consultant, Scientist, Technical Writer

Associate Consultant Scientific Writer
Our client, a global pharmaceutical organisation are currently recruiting for an Associate Consultant Scientific Communications to join their newly created Global Scientific Communications team. As Associate Consultant Scientific Communications 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
• 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, GSC management team, GSC outsourcing team, technical lead consultants, and vendor staff
• 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 the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews
• 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

Requirements
• Bachelor’s degree in scientific, health, communications Or, Bachelor’s degree in any field with at least two years of clinical development experience ( PhD preferred)
• 4 or more years of medical writing experience within the pharmaceutical industry or as a part of a medical writing agency.
• Demonstrated experience in publication writing
• Involvement in publication planning strategy
• Demonstrated ability to manage complex environments with stakeholders
• Experience with publication guidelines
• Very strong project management skills
• Excellent communication skills

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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