Website Alsinova
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:
- 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 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:
- 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 fluent in French and English (spoken and written).
- 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
Alsinova
Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.
Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10.000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.
Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.
More on the Group on our websites https://alsinova.com and https://astek.net.
Our benefits
Joining Astek means choosing:
- an experience accelerator, where every assignment is an opportunity to progress
- access to a multitude of technically exciting projects for our clients as well as internally
- individualized, local support for a tailored career path
- continuous learning, thanks to our internal training academy
- a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices
Let’s move forward.