medac Gesellschaft für klinische Spezialpräparate mbH

Senior Medical Writer (m/f/d)

Wedel bei Hamburg
Feste Anstellung
Vollzeit, Home Office

About medac

medac is a prestigious Hamburg pharmaceutical company specialising in the new and further development of therapeutic and diagnostic agents for oncological, urological and autoimmune conditions. Although we can already look back on over 50 years of successful company history and solid values, we are not bound by the past. Over 1,800 dedicated employees ensure the reliable provision of innovative and safe pharmaceuticals and medical devices. In the process, we run our business in a forward-looking, personal manner, with a focus on the individual quality of life of the patients.

For our im Bereich Operations | Operations department, we are looking for you as a

Senior Medical Writer (m/f/d)

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.

Your tasks

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 the 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

Your qualifications

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 processes, regulatory and drug safety requirements, clinical data management and statistical processes and good data-interpretation skills