@Biocartis_

Technical Writer

Mechelen / 2016045
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Full-time
Experience Required
  • A minimum of 5 years relevant experience with skills in Technical Writing and Publishing;
  • Knowledge of the software used in Technical Writing and Publishing in multiple languages; i.e. Madcap Madpak, Flare and Lingo;
  • Preferable to have experience in Medical Devices or IVD technology;
Education

Bachelor in engineering, science or related discipline, or equivalent by experience;

Functional Area
Egnineering
Travel Percentage
0-5

Purpose of the position:

The Technical Writer is responsible for defining and carrying out the activities which are related to the labelling (but not labels), and coordinates the review, the formatting and the publishing of the customer documentation and instructions related to the Biocartis molecular diagnostics platforms. This is currently the Idylla platform. 

Member of the Labeling and Content Management team within the Create sphere.

 

Tasks/outcome domains:

  • Handle the creation and ongoing maintenance of the Instructions for Use (IFU) of the Idylla platform (all sub-systems) and the tests and assays (paper and digital documents) in multiple languages, for the following:
    • The IFU - Operator Manual for the Idylla instrument and console and software
    • IFU and Assay Instructions of Idylla tests and assays developed by Biocartis as the legal manufacturer
    • Tools - Lab Integration Guide and Site Preparation Guide
    • Service Manuals
    • Other required customer facing documentation and guides upon request
  • Coordinate the input required from design specialists in the development teams; and drive the documentation collaboration, review and approval process;
  • Coordinate and facilitate the translation process, including review and approval of translated documentation;
  • Perform the necessary lay outing, readability and publishing of the final documents;
  • Participate in cross-functional sub projects;
  • Participate in the supplier selection process and relationship development with translation or graphic design partners;
  • Comply with and continue to monitor specific in country regulations and standards as they apply to Labeling;
  • Evolve best practices for labeling designs against required International standards and the creation of templates to facilitate future documentation improvements;
  • Understand and comply with company guidelines and regulations

 

Profile & Competencies:

  • Bachelor in engineering, science or related discipline, or equivalent by experience;
  • A minimum of 5 years relevant experience with skills in Technical Writing and Publishing;
  • Knowledge of the software used in Technical Writing and Publishing in multiple languages; i.e. Madcap Madpak, Flare and Lingo;
  • Preferable to have experience in Medical Devices or IVD technology;
  • Demonstrated competency in coordination and/or project management to keep track of multiple activities and stages of completion;
  • Interpersonal skills to take part in a dynamic team environment while taking on multiple projects simultaneously;
  • Quality Orientation; consistently complies with product/ service quality standards with attention to detail to ensure accurate, high quality documentation output;
  • Good team skills - a high level of enthusiasm and motivation, able to build consensus with multiple stakeholders;
  • Innovation: Contributes innovative ideas that lead to positive business results; encouraging and adopting new ways of looking at problems, processes and solutions;
  • Judgment: Ability to make timely and sound decisions based on thorough consideration of relevant information and the pros and cons of alternatives;
  • Advanced knowledge, orally and in writing of Dutch and English;
  • Microsoft Office products.
  • Thrive in a changing and innovative environment.

 

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

 

Interested?

Please apply by e-mail and send your CV and motivational letter to HR@biocartis.com  using the job ID 2016045 as a reference.

go back