This is what you will do:
The Medical Operations Manager is responsible for project management in the medical affairs department of the country or cluster. He/She collaborates closely with the Country Medical Director and all other medical affairs colleagues as needed. Responsibilities include the support of the medical plan development and execution, related milestone and budget controlling, KPI reporting, and support of selected activities like local study initiatives. He/She ensures continuous improvement of operational aspects of Country Medical Affairs programs (including med/education events, advisory boards, scientific exchange meetings), Medical Affairs contracts & agreements, Medical Information requests management, local policies and SOPs creation and update.
You will be responsible for:
- Ensures that all the locally needed policies and SOPs are in place, adapted and updated according to the corresponding Global documents and local regulations
- Supports the onboarding of new Medical Affairs employees including coordination of trainings
- Support medical plan and development in accordance to defined timelines
- Coordination of preparation of business reviews and related ToDo’s for all therapeutic areas in medical affairs
- Leadership to finalize quarterly updates and reporting of tactical medical plan for the running year (e.g. MAP tool, Scorecards)
- Overall management and controlling of medical AOP in Germany in close collaboration with medical director and therapeutic area leads to ensure project spending according to the plan
- Supports establishment of KAM and related activities
- Management of insight reports
- Partners with Country Medical Teams for the preparation of audits and inspections, including proper follow up of actions and implementation of CAPAs
- Supports AMNOG dossier development related activities in therapeutic areas as needed
- Management of submissions for the International Country Dashboard, like Advisory Board Summaries, Medical Affairs KPIs, status & budget updates related to the medical tactics
- Tracks the submission and progress of ISRs, grants and requests submitted to GATM for compassionate use as well as proposed studies
- Supports the initiation and management of local RWE projects
- Supports entering input in the alexLaunch Tool (PROPEL) for upcoming launches and train colleagues using the tool and process
- Supports launch preparations and teams
- Leads and directs additional team members
You will need to have:
- Advanced degree in life sciences, business, MD, or PharmD
- Experience in medical affairs is a plus
- Solid background and experience in thrombosis//hemostasis/cardiology/neurology, and understanding of drug development and life‐cycle development of a product strongly preferred
- Basic knowledge of local pharmaceutical regulations
- Excellent project management skills
- Solution oriented and ability to work in a complex environment
- Good analytical skills as applied to medical, scientific, and technical information
We would prefer for you to have:
- Ability to motivate and influence others
- Excellent written and verbal communication skills in local language
- Knowledge in clinical development is a plus (clinical trials, registries, RWE)
- Excellent communication skills with proven ability to deliver impactful presentations
- Should have solid ability to attend, understand and participate in pan-EU level meetings and tele conferences conducted in English