Cookie-Settings

We use cookies to give you the best experience possible with our website and to improve our communication with you. We consider your selection and will only use the data you have approved us to gather.

These cookies help making a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.

These cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously. With this information we can constantly improve the experience we offer on our website.

These cookies are used to track visitors across websites. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third party advertisers.

DE
  • Home
  • About medac
  • Information for patients
  • Healthcare professionals
  • Products
  • Career opportunities
  • Media
  • Find jobs
    Find jobs
    Work Experience
    Divisions

    Senior Medical Writer (m/f/d)

    from: 23.11.2020
    You are an innovative person with a passion for details and team spirit? We are looking for graduates for the scientific and pharmaceutical sector. We can offer you new challenges, regular continuing education courses, internal mobility and attractive benefits in a company that thinks of the future and acts accordingly. With passion, team spirit and appreciation for one another.
    • Perform medical writing activities according to GCP/ICH & EMWA guidelines, and relevant laws and regulations.
    • Write clinical trial related documentation such as clinical trial protocols, amendments, patient information sheets, clinical trial reports, and investigator brochures
    • Write and update clinical overviews
    • Participate in decision making process for analysis and display of clinical data
    • Ensure that outsourced activities are conducted according to GCP/ICH guidelines and our medac standards
    • Check in cooperation with the clinical experts that trial protocol designs, key messages of the clinical trial report and other clinical submission documents are in line with the Clinical Development Plan and trial results
    • Quality control and/or review of documents
    • Life science degree or equivalent
    • Profound experience in regulatory medical writing
    • English native speaker or excellent knowledge of the English language and strong communication skills, both written and verbal to successfully articulate concepts and ideas
    • Good knowledge of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH-GCP, EMWA, FDA, EMA, PMDA)
    • General knowledge of clinical development process, regulatory and drug safety requirements, clinical data management and statistical processes and good data-interpretation skills

    Wenn Sie eine neue berufliche Herausforderung und eine zukunftsorientierte Aufgabe suchen, freuen wir uns auf Ihre Bewerbung mit Angabe Ihres frühestmöglichen Eintrittstermins und Ihrer Gehaltsvorstellung. Hierfür steht Ihnen unser Online-Bewerbungsformular auf medac.de zur Verfügung.

    Nach oben