Regulatory Medical Writer
I am currently working with a global pharmaceutical who are seeking experienced Regulatory Medical Writers to join their team.
As Regulatory Medical Writer you will work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).
- 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.
- 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.
- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.
- 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).
- Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.
- Bachelor's degree in a scientific, health, communications, technology health related field.
- Demonstrated experience in technical/ regulatory scientific writing.
- 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.
This is an opportunity to play an integral role in the establishing of this new team and join an innovative and cutting-edge organisation who places people at the centre of all they do.
A detailed job description is available, please contact us for a confidential conversation regarding this exciting opportunity and your career progression.
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