Keyrus Life Science is looking on a regular basis for Medical Writers to join our consulting team for client (from big pharma to small biotech) projects based in Belgium.
This job description is an example on how your job could look like. Once we have a specific project and client you will be informed and you will have of course the choice if you would like to be presented at our client.
Your potential challenges could be:
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).
And some more technical jobs in Medical Writing might also require:
- The writing of price and reimbursement files for the authorities and working in tandem with a Value and Patient Access Manager.
- Most of the content for the file will be delivered, but occasionally additional literature searches may be needed.
1 year of experience in Medical Writing is a must have. Contractors with experience in oncology is an asset.
- Excellent Writing skills to effectively and clearly communicate in French and English.
- Scientific degree (quick understanding of the scientific information).
- Ability to communicate scientific or medical information in a clear and concise manner.
- Proficiency in Word, Excel, PowerPoint, endnote (or similar system), email, and Internet.
- Familiarity with the principles of clinical research (eg, use of clinicaltrials.gov).
- Ability to interpret and present clinical data and other complex information.
- Ready to take initiatives related to the improvement of the template.
- Organizational skills; used to deliver on time.
- Ability to work on different projects in parallel.
- Good collaboration.
What we offer
Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.
As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, fuel card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
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 skilfully, 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.