Description
We are looking for a
Global Medical Manager (Anti-Infectives) (m/f)
Reference: -en
Start: asap
Duration: 5 MM++
Place: in Austria
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Provide medical/scientific expertise and input to cross functional drug development initiatives to enrich the product portfolio
- Conduct medical assessments for new product opportunities
- Prepare and review SmPCs and PLs for registration procedures in English and update those accordingly for variations and renewals
- Create, update and review the medical, clinical and preclinical documentation for registration dossiers in e-/CTD format
- Review of post marketing studies in close collaboration with the Head Post Marketing Studies
- Active collaboration with cross-functional partners, e.g. other functions within Product Development, Global Pharmacovigilance, Commercial Operations, Drug Regulatory Affairs
- Act as medical representative for drug development project teams
Your qualifications
- Degree in Science (preferably pharmacy or medicine)
- Fluency in English, basic language skills in German
- Relevant experience within the pharmaceutical industry in medical affairs, development, pharmacovigilance or regulatory affairs
- Demonstrated knowledge and expertise in a designated therapy area
- Analytical skills and strategic thinking ability
- Team work and communication skills
- Strong sense of ownership and accountability
- Capacity to work cross-functionally in a matrixed and integrated way
Skills:
- Medical affairs manager
Keywords: Medical Affairs Manager pharmacy medicine SmPCs review dossiers pharmacovigilance regulatory