METRONOMIA - Director Medical Writing (m/f/d)
Since 1990, METRONOMIA Clinical Research GmbH represents quality, competence, continuity and absolute customer orientation. We are a growth-oriented, mid-sized company that offers expert Biostatistical, Data Management and Medical Writing services in clinical research and serves international clients and projects from various industries including pharmaceutical, biotech and medical devices. Our clients value the competence and commitment of our employees, the basis of Metronomia’s success. Come and join us as:
Director Medical Writing (m/f/d)
Your responsibilities
- Lead the Medical Writing team to ensure timely delivery of high-quality documents such as clinical study reports, clinical study protocols and development- / periodic safety update reports.
- Priority setting, workload distribution and resource planning, with the aim of ensuring both adequate assignment of resource to projects and balance of workload across the team.
- Contributing to medical writing and quality control of documents such as clinical study reports, clinical study protocols and development/periodic safety update reports.
- Attend/lead project related calls, regular client status calls and medical writing team meetings.
- Maintain comprehensive knowledge of regulatory guidelines, trends and standards in medical writing and clinical research and attend conferences.
- Recommend, assist and actively contribute to the development and improvement of SOPs and standards including processes and all relevant document templates.
- Represent medical writing in regulatory inspections and sponsor audits.
Your qualification
- Longtime extensive experience in regulatory medical writing in clinical research, especially protocols and CSR's.
- Advanced word processing skills, including MS Office, software and systems knowledge in document management systems.
- Excellent written and oral English.
- Hands-on medical writing skills as well as ability to handle team, timelines and task oversight.
We offer you flexibility in work hours and work location. A compensation package that includes a fixed salary, performance- and success-related salary components as well as extensive company social benefits. Internal and external training which are planed together in regular employee appraisals and documented for implementation. Last but not least a diverse team of highly motivated and qualified colleagues who are extremely committed and efficient in an open, appreciative and caring working atmosphere.
Upload a comprehensive application, your availability and your salary expectations. Please note that Metronomia uses the "Recruiter on demand" service from Constares GmbH to support the management of applications.
Metronomia Clinical Research GmbH ~ Rudolf Köhne-Volland ~ Managing Director
Paul-Gerhardt-Allee 42 ~ 81245 München ~ www.metronomia.net