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ubstantive and flexible Medical Writer position within a growing organization
Het bedrijf / The company
Our client is founded in 2001 and is nowadays an independent company that offers professional medical writing services all around the world to the biotechnology, pharmaceutical, food and medical device industry. Over the years, they have gained extensive experience in the presentation and interpretation of data into well-structured and clear scientific documents and have contributed to several successful regulatory submission dossiers. This organisation supports companies in the preparation of the documentation to speed up the development processes on the way to regulatory submission and approval. Today, the organisation is a group of experienced professionals, familiar with all the various types of documents in a wide range of therapeutic fields. For the growth of the organization, they are looking for a proactive and responsible Medical Writer. A challenging position with a lot of freedom to organize your own working hours and the possibility to work almost completely from home.
De functie / The role
As a Medical Writer you will be responsible for the preparation and coordination of a wide range of clinical and regulatory documents. This includes Investigator Brochures, Clinical Study Reports, Clinical Trial Protocols, Clinical Summaries of Efficacy and Safety and Clinical Overviews. These documents must be of high quality and must adhere to regulatory guidelines and company styles and processes. You will be writing clearly, concessive and consistently simple or complex documents compliant with the needs of the regulations or questions of the authorities, as appropriate. Also, you will perform literature searches or reviews as necessary to obtain background information and training for development of documents and carry out novel or complex assignments with minimal assistance. You are going to ensure document content and style adhere to FDA/EMA or other appropriate regulatory guidelines, and comply with internal and client SOPs/Wis, and style guidelines. Furthermore, you will perform peer reviews of draft documents prepared by other Medical Writers before external distribution when requested. You will attend or lead internal and client team meetings and initiate or participate in process improvements and training initiatives. A responsible and highly substantive position where you help the team by sharing your knowledge and experience!
Het profiel / Your profile
• a master’s degree in a scientific discipline (preferably within biological, veterinary, pharmaceutical or medical sciences)
• at least 3 years of experience in Regulatory Medical Writing
• secure, communicative, and pro-active
• responsible, team-oriented, and excellent computer skills
• excellent written and verbal language skills in both English and Dutch (C1 or better)
Het aanbod / The offer
• independent and substantive medical writer’s position
• being part of a growing organization
• ability to schedule your own working hours and work completely from home
• possibility to initiate and participate in process improvement and training initiatives
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-054-DD, to Tim van Loon: firstname.lastname@example.org.
For further information, please call Tim van Loon at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Tenslotte ..... / Finally ....
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.