We love what we do and our business is growing continuously.
Due to the continuous growth we always need good people in different operational working areas of our company. However, our aim is to be the best CRO proving the best services to our clients.
For this reason we only need the best people.
Medical Writer (MW)
Our Medical Wirter (MW) is responsible for the clinical trial/clinical investigation/clinical evaluation or other specific documents preparation according to the corresponding SOPs, ICH, European and other local regulations in respective countries and/or according to the Sponsor´s SOPs/ requirements.
The successful candidate will be responsible for creating and reviewing documentation that relates the different phases of a clinical trial, as well as market authorisation. Apart from other documents these are mainly clinical study reports (CSRs), Clinical Evaluation Report (CER) and clinical study applications (CTAs). A key skill of medical writers is to be able to present scientifically information as clearly and accurately as possible along with the skill to bind them into a full story, which is vital when dealing with the complex process of a clinical trial. Another important aspect of a medical writer’s job description is to work cross-functionally with regulatory affairs and clinical operations teams to compile the correct regulatory and clinical data needed for the documentation.
In this international business, you need to speak and write German and English fluently. A third language is appreciated. A good self-confidence, good communication skills and ability to work independently are considered as very important for this job. Depending on your performance, we offer you individual possibilities to develop your career.
Duties and Responsibilities:
Writing expert responsible for the research, writing and editing of study level and submission level documents.
Interpreting data and advising sponsors as to how best to present data in light of regulatory agency requirements.
Working with department to ensure that specific requirements with respect to document content and format are met.
Identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered
Responsible for SAE handling and reviewing according to SOP and European and regulatory requirements.
Required Qualifications and Skills:
At least Master level degree in medicinal related field, natural science or any equivalent qualification and relevant work experience
Expertise in MS Office Suite and ability to operate with general office software
Excellent written and verbal communication skills (English) and interpersonal relationship skills
Demonstrated problem-solving, critical thinking, and investigative skills
Good self-confidence, communication skills and ability to work independently
Attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Good knowledge of medical terms and human anatomy
Knowledge of Medical Device regulations, Drugs regulations, and regulatory reporting regulations
1 + years of related writing experience (biomedical research, medical education, medical writing, or similar field)
If you are interested, send us your electronic application (with your salary expectations and earliest start date) and your CV to:
The ideal medical writer
He has the skills to prepare medical and scientific information with expertise and target group-oriented. In addition to his talent for writing, he also has the ability to think about the target group and address them in “their own language”.
A feeling for language, certainty of style, the mastery of medical terms combined with legal, regulatory and insurance-related knowledge are the ideal conditions that a medical writer has to bring with him.