Scientific Writer (remote, full-time)

To write complex scientific, clinical, and regulatory documents (such as protocols, clinical study reports, and publications) over a wide range of therapeutic areas according to appropriate standards and requirements (e.g., ICH). To mentor more junior scientific writers.The responsibilities for the Scientific Writer include, but are not limited to, the following:

• Write investigational medicinal product dossiers, investigator brochures, clinical study concept protocols, protocols, and protocol amendments, informed consent forms, assent forms, clinical study reports, and summary (Module 2) documents for licensing applications
• Compile and publish complex documents (e.g., clinical study reports)
• Write patient narratives and other pharmacovigilance documents (e.g., DSURs, PBRERs, RMPs)
• Write and edit publications for peer-reviewed scientific/medical journals
• Write abstracts, posters, and presentations for scientific congresses
• Translate scientific articles, clinical documents, and media materials
• Perform reviews of the literature
• Participate in the review of statistical analysis plans and provide input on the layout of Tables, Figures, and Listings
• Maintain internal databases for 4Clinics or clients
• Perform Quality Control or peer reviews of documents generated by 4Clinics or clients
• Participate in marketing support
• Ensure that document and standards timelines are met
• Participate in the creation, usage, and maintenance of 4Clinics document templates and SOPs

• At least 10 years of experience as a scientific writer
• Experience mentoring more junior scientific writers
• Graduate or post-graduate degree in medicine, pharmacy, or a scientific field
• Fluent in English with excellent written proficiency in the language
• Computer literacy (Word, PowerPoint, Excel)

• You have a keen eye for detail and good communication skills
• You can work independently (and remotely) and yet be a great team player
• You have a flexible approach to work
• You are well organized and with attention to detail while keeping a “getting the job done” mentality
• You are client-focused
• You are focused on delivering high-quality results on time
• You are sensitive to cross-cultural differences.

You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 200 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, data scientists, statisticians, data analysts, medical and scientific writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries. 
  
 We all work remotely, setting our own time schedule, based on a “getting the job done” mentality.  This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Paris (France), Bogota (Colombia), Johannesburg (South Africa), Bangkok (Thailand), and Durham (United States). You may need to travel occasionally. 
 
 At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application by filling out the following short form. The call will remain open until the position is filled.

P95 is an Equal Opportunities Employer. The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, marital status, genetic information, parental status, social origin, or condition. We base all our employment decisions on merit, job requirements, and business needs.