Senior Medical Writer
il y a 2 jours
For the expansion of our team, argenx is looking for a Senior Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according argenx standards.
This position can be filled in remotely with regular travels to the office in Ghent, Belgium.
Key Responsibilities:
- Support the clinical medical writing team, in developing content for, writing and editing a variety of scientific and medical documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives and annual reports
- Draft and manage documents that are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations
- Ensures all clinical documents are standardized with the use of document templates, in order to ensure the quality and consistency of documentation across programs
- Partner with Quality Assurance (QA) during audit of clinical documents to ensure timely response to findings
- Collaborate with clinical project teams including Project Manager, Clinical Study Managers, Medical Directors and Biostatistics to ensure project deadlines are met, by providing content development support, research, and editing functions for each program
- Ensure proper development and coaching of junior writers
Desired Skills and Experience:
- Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
- Ability to proofread documents for compliance with internal and external guidance documents
- Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
- Ability to work precisely according to procedures and regulations
- Excellent written and verbal communication skills
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work autonomously, as well as in a team
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
- Experience in electronic publishing format preferred
Education and Qualifications:
- Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred
- Minimum of 3-5 years of pharmaceutical/biotechnology related medical writing experience required
- Knowledge of all FDA and ICH guidelines for clinical reporting required
- eCTD development, publishing and submission experience preferred
- Therapeutic experience in biologics preferred
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