Alsinova provides end-to-end life science research services that combine medical expertise with AI-driven tools. As a non-clinical and clinical research company, Alsinova uses a Digital CRO approach, data science, automation, and machine learning to deliver RWE, regulatory affairs, and vigilance support. It operates across 26 countries with flexible collaboration models. Supported by AI and human experts, it tailors solutions for pharma, biotech, and medical device clients. The company targets global life science programs with scalable partnerships.
BioEquivalenceBiostatisticsClinical Data FabricClinical OperationsClinical Project ManagementClinical ResearchConsultingData ManagementData SciencesDecentralized Clinical TrialsDigital EnablementeHealthFSPLife SciencesMedical WritingPhase I to IVQuality AssuranceRegulatoryRWESafetyVigilancealsinova.com
ALSINOVA CRO
Alsinova provides end-to-end life science research services that combine medical expertise with AI-driven tools. As a non-clinical and clinical research company, Alsinova uses a Digital CRO approach, data science, automation, and machine learning to deliver RWE, regulatory affairs, and vigilance support. It operates across 26 countries with flexible collaboration models. Supported by AI and human experts, it tailors solutions for pharma, biotech, and medical device clients. The company targets global life science programs with scalable partnerships.
BioEquivalenceBiostatisticsClinical Data FabricClinical OperationsClinical Project ManagementClinical ResearchConsultingData ManagementData SciencesDecentralized Clinical TrialsDigital EnablementeHealthFSPLife SciencesMedical WritingPhase I to IVQuality AssuranceRegulatoryRWESafetyVigilancealsinova.com
HQBoulogne-Billancourt, FR
Team Size216
Open Jobs69
Total Funding-
Latest FundraiseUnknown
Join the Team
Medical Writer - Montréal, Canada (F/M)
HybridMontreal, Quebec, CA
Hybrid • Montreal, Quebec, CA
What We Will Accomplish Together
The Medical Writer will support the clinical team by providing a thorough and deep understanding of the client’s demands with regards to research question, objectives and outcomes, and will provide educated guesses, advice and feedback with regards to clinical studies designs and methodologies.
Your Mission (should You Decide To Accept It)
The Medical Writer will be brought to produce clinical protocols, build study designs along with the statistical team, proceed to literature reviews, write investigator brochures and research proposals, to only name these, and will also produce documents for internal use.
Your Daily Activities Will Be
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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).
You
PhD degree in science
2-5 years experience as a medical writer or related field.
Strong ability with reference management software.
You have a good knowledge of ICH-GCP guidelines.
You have a good understanding of the significance of clinical, epidemiological, and scientific data in general.
Excellent writing abilities with strong knowledge of writing formats and methodologies according to Regulatory Agencies and/or document types requirements.
Experience with the MS Office Suite software with strong formatting skills.
You are detail-oriented with strong an analytical and organisational mindset.
Must be able to render a concise, accessible and clear content to the client and internal team.
Adaptability and quick-learning. Meaning, easily grasping the objective of a clinical project and get acquainted rapidly with various health-related research areas.
Autonomy, sense of initiative and creativity.
Ability to synthesize information in a short timeframe.
Ability to work on multiple projects simultaneously while respecting the prescribed deadlines.
Team player
Critical thinking
You are fluent in French and English (spoken and written).
Our Benefits
Rejoindre Astek, c'est choisir :
un accélérateur d’expérience, où chaque mission est une opportunité de progresser
un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
un apprentissage continu, grâce à notre Académie de formation interne
un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let's move forward.
