Regulatory Scientific Communications Associate

Our client, a global pharmaceutical organisation are currently recruiting for a Scientific Communications Associate to join their newly created Global Scientific Communications team. As Regulatory Scientific Communications Associate you will work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences including, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, 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 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
• 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
• Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s)
• 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

• 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
• Graduate degree with formal research component or in life sciences
• Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
• 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)
• Experience writing regulatory, clinical trial documents and/or publications
• Experience in clinical development, clinical trial process or regulatory activities
• Demonstrated project management and time management skills
• Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates)