Patient Access Collaborative

Medical writer

• Execute consulting projects with a focus on developing market access and dossier strategies, including preparing related workshops and participating in oral hearings with relevant authorities
• Independently prepare benefit assessment dossiers for pharmaceuticals within the AMNOG process and for EU Health Technology Assessments (HTA) in collaboration with clients
• Perform scientific and statistical analysis, interpretation, gap analysis, and presentation of clinical study results
• Independently review scientific literature and prepare and document qualitative and quantitative analyses
• Collaborate in interdisciplinary, agile teams composed of clients and colleagues
• Apply state-of-the-art, AI-supported technological solutions and New Work methods (e.g., Design Thinking, SCRUM, Kanban)
• Actively contribute to the continuous development of Kintiga
• Receive targeted training and professional development in key market access disciplines.

Medical Writer

Compliance

• Management of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products
• Management and/or support of activities as Responsible for Information and Publicity (RIP)
• Management of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV
• Contribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection.
• Contribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials.
• Management of stakeholder interactions including advisory boards and scientific presentations.
• Involvement in medical information activities at local and global level. This entails replying to medical enquiries and relevant reporting of adverse events, technical complaints or special situations.
• Management of field market access research.

Medical Writer

Regulatory Affairs Manager