Work and interact extensively with internal subject matter experts and external contacts within crossfunctional teams for the preparation of high quality clinical, regulatory and scientific documents. High quality refers to scientific content, organization, clarity, accuracy, format, and compliance with regulatory and internal guidelines, styles and processes..
- Writing, reviewing and editing of technical documents including but not limited to:
- Clinical study protocols
- Clinical study reports
- Investigator Brochures
- Clinical summaries and overviews
- Investigational New Drug applications
- Clinical Trial Applications
- Scientific advice briefing documents
- Pediatric Investigation Plans
- Orphan Drug applications
- Risk Management Plans
- Clinical parts of Marketing Authorization Applications
- Presentations to support discussion meetings in the context of all the above
- Clinical/scientific content for Ablynx websites
- Ensuring that the completed documents are accurate, in line with approved format, and compliant with applicable external and internal guidelines.
- Working with external vendors for the coordination, review and finalization of any outsourced document writing activities
- Publishing of clinical study protocol and trial results data on external databases as per regulatory requirements
- Developing and maintaining document templates
- Enabling process improvement initiatives through sharing of best practices
- Contributing to development of processes, including preparation of standard operating procedures
Skills, expertise and contribution
- Mastery of the English language, particularly written
- Excellent writing skills, ability to extract key messages from complex datasets and present these in a clear and accurate way
- Scientific background enabling thorough understanding of content to be written
- Awareness of regulatory environment for clinical trials in EU, US and other regions, particularly with respect to requirements applicable to (clinical) regulatory documents with respect to content, level of detail, format, etc., including requirements for electronically submitted documents (e.g. eCTD)
- Strong skills in document management, generation of regulatory documents with references, bookmarks and hyperlinks.
- Computer knowledge. Proficient in Windows and MS Office (Word, Excel, Powerpoint), publishing and document management tools. Is able to solve any such problems that might occur with respect to document formatting or publishing either directly or through interaction with IT, software vendors or consultancy providers
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail and while maintaining agreed timelines
- Ability to work under time pressure to achieve goals within set timelines while maintaining quality
- Team Player
- Organizational and planning skills
- Communication skills
- Conflict handling and problem solving
- Detail oriented, methodical and goal driven
- Being accountable: exercising judgment/impact of decisions/consequence of error
- Bachelor or Master degree (Medical, Pharmaceutics, Biomedical Sciences) , dependent on level of relevant experience
- Expected experience: Minimum of 3 years of relevant experience in (Clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.
Job grading and career progression as Medical Writer will depend on the magnitude of the job as measured via the job grading tool (Hewitt) as well as via the overall impact by the individual on the team, department or company. The job grading will be evaluated based on 5 criteria as described in the above: Knowledge & Application, Problem solving & Innovation, Interaction, Impact and Accountability. Individual impact will be determined by factors such as Experience, Informal leadership, Performance, Job management & competences versus current job description and the individual s Critical value. The overall assessment will lead to the band and/or level of the Medical Writer.
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