Medical Writer Senior
As a Senior Medical Writer your main tasks will be to :
- Synthesize literature review findings into reports in various therapeutic area ;
- Write, edit and update clinical development related documents with the highest level of technical accuracy (clinical protocols, informed consent forms, study reports, investigator brochures, clinical trial results, annual reports, statistical analysis plans, briefing documents, paediatric investigational plans and other clinical documents) ;
- Lead the process of critical review of clinical documents and incorporate multiple reviews into successive drafts. Provide quality control (QC) support for clinical documents as needed ;
- Ensure the quality of clinical documents by maintaining and promoting familiarity with International Council on Harmonization Good Clinical Practice (ICH-GCP) guidelines, and other standards ;
- Liaise with authors and clients regarding scientific content ;
- Write, review and edit manuscripts, posters, abstracts… ;
- Attend internal and external team meetings ;
- Respect quality commitments ;
- Participate in the continual improvement of the Quality System ;
- Identify, record and ensure corrections of non-conformities ;
- Update the Medical Writing process and templates and ensure compliance with current regulatory guidelines and best practice ;
- Assist with the development of business proposals related to Medical Writing functions (preparation of budget grids and financial and technical proposals for clients).
Besides your main tasks , you will also be responsible for the integration of newcomers and training of junior profiles which includes to :
- Allow smooth integration of newcomers ;
- Supervise junior medical writers and ensure their training regarding applicable regulatory guidelines and medical writing practices.
Required skills and qualities and expected level :
- Fluent in English (spoken and written) ;
- Knowledge of ICH-GCP guidelines ;
- Excellent command of Office software (Excel, Word, PowerPoint) ;
- Good understanding of the significance of clinical, epidemiological and scientific data in general ;
- Attention to detail ;
- Analytical and organised ;
- Pro-active and autonomous ;
- Good interpersonal skills.
Required level of education :
- Degree in medicine or PhD in Science (Biology, Pharmacy…)
Required work experience :
- At least 3 years of experience as a medical writer in a Contract research Organization (CRO), pharmaceutical, and/or biotechnology environment.
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever