Medical Writer – Waterloo, Belgium (F/M)

Work set-up: 
On-Site
Contract: 
Full time
Work from: 
Waterloo (CA)

Astek Middle East logo
Astek Middle East https://astekgroup.fr/country/saudi-arabia/?lang=en
1001 - 5000 Employees
See all jobs

Job description

What We Will Accomplish Together

Alsinova is looking on a regular basis for Medical Writers to join our consulting team for clients' projects (from big pharma to small biotech) based in Belgium.

Your Mission (should You Decide To Accept It)

Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.

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).

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.
  • 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.

You

  • Scientific degree (quick understanding of the scientific information).
  • 1 year of experience in Medical Writing is a must have. Contractors with experience in oncology is an asset.
  • 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.
  • Excellent Writing skills to effectively and clearly communicate in French and English.
  • 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.

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.

Required profile

Experience

Are you interested?

Related jobs

See more jobs