swipe naar links of rechts om te bladeren door de jobsgebruik de pijltjestoetsen ( and ) om te bladeren door de jobs
Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.
If you are a Technical Writer who's looking for a new challenge in a Pharmaceutical company, feel free to apply !
firstname.lastname@example.org / +32(0)497/61.85.75
The Pipeline Device Development department of our client's company is recruiting a Technical Writer.
The primary goal of the function is to author reports and templates and manage documentation for device development team, thus supporting activities relating to the device development, transfer, assembly process qualification and clinical/commercial manufacturing support. They will work in a team environment, collaborating with various quality, regulatory, scientific, clinical and manufacturing experts. They will author and review relevant documents that support regulatory license applications and hence have to be of a very high standard. The data to be summarized in the reports will be collected from electronic and physical repositories, verified, cleaned, analyzed and visualized. Based on this, the writer will then generate scientific reports supporting the design history file and regulatory filings (Development and Technical Reports in English) and contribute to the preparation of regulatory submissions with business partners. The reports will be written in English. The technical writer will manage their review and approval in the appropriate electronic document management system. The candidate will also contribute to the data review of the relevant CMC sections of regulatory dossiers.
The main activities of this function will be:
Source data from batch records, lab books, data management systems and existing reports, evaluating the information, and generate summary reports
Author device development protocols, reports, risk assessment and templates in English
Manage documents within systems
Data mine from physical and electronic repositories
Manage, analyze and visualize data
Generate training materials based on lessons learned exercises
Present/discuss documentation in project team meetings
Liaise with other departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc…)
All these activities will be performed in compliance with Health, Safety & Environment (HSE) as well as Quality policies and standards and with the regulatory requirements for each development phase of the products.
Minimum of 3 years working in the pharmaceutical/biologics/medical device industry
Operational GMP or quality experience would be a distinct advantage