Clinical Development & Medical Affairs
- Medical affairs and clinical development strategies
- Management of data monitoring boards & steering committees
- CTA regulatory submissions and follow-up with Regulatory Authorities
- Regulatory submissions and follow-up for marketing authorizations
- Drug safety and pharmacovigilance
- Collaborative networks set up (networking, collaborative project management)
- Trainings in the businesses of pharmaceutical industry : ICH-GCP, Regulatory, marketing and communication…
Business Development & Market Access
- Regulatory support for market access
- Marketing authorizations management, renewals and modifications
- Market access and market development
- Planning and conduct of marketing actions towards regulatory authorities as well as Key Opinion Leaders
- Sales and business development
- Medical communication and product promotion
- Recruitment, training and management of product-exclusive marketing and sales teams
- Identification and selection of scientific and industrial partners