Jobbeschreibung
Otsuka Novel Products GmbH (ONPG) is the global headquarter for a special pharmaceutical business within the Otsuka group. With an international network of 168 subsidiaries and 34,400 employees in 32 countries and regions across Europe, Asia-pacific, America and the Middle East, Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health.
Otsuka's Global Tuberculosis Project consists of teams and affiliates working on different aspects of the project, from medical research and clinical development, to commercialization, pharmacovigilance, regulatory issues, access strategies, strategic alliances and more.
For our Medical Affairs Team based in Munich, Germany, with remote working options, we are recruiting one
(Senior) Manager Medical Affairs (m/f/d)
In this role, you support the Director Medical Affairs in representing our medical department in cross-functional teams. The role is a bridge between scientific research and commercial functions and provides medical and scientific input as well as involvement in a variety of activities such as clinical operations, product development, regulatory, market access and commercialization.
- Responsible for the provision of medical/scientific information services to internal key stakeholders from various departments, e.g. Medical Affairs, Clinical Development, Global Health, Public Affairs and Commercial (as needed)
- Conduct proactively scientific and clinical literature searches and prepare data summaries to provide strategic input into decision-making processes
- Accountable for the preparation or development of scientific communication materials (e.g. presentations)
- Maintain a comprehensive expertise on products and disease area
- Responsible for the review and approval of promotional and non-promotional materials in any form for external use as well as artwork according to applicable laws and regulations
- Assumption of the Deputy Information Officer role according to §74a German Drug Law (AMG) and § 56 AMG Austrian AMG
- Perform and oversee the implementation and associated activities of updated product information (Summary of Product Characteristics and Package Leaflets)
- Responsible for the regular reviews of regional and global SOPs related to Medical Affairs, Medical Information and Medical Compliance
- Lead the authoring, review and approval of medical information response documents
- Participating actively in national and international scientific conferences with subsequent preparation of reports and presentations
- Represent the company at national conferences strengthening the reputation of Otsuka
- Scientific university degree in medicine, biology, biochemistry, pharmacy or related field, preferably with MD or PhD
- Expertise in immunology or infectious diseases highly desired
- Professional experience in a pharmaceutical company with operational experience in Medical Information and Medical Affairs for at least 5 years
- Ability to effectively communicate written and verbal scientific data and to understand clinical implications of data
- Working in cross-functional / global project teams
- Strong communication skills, work independently, and act responsibly
- Fluent in English (spoken and written), German language skills (would be a plus for the Information Officer function), any other foreign language would be a plus
- Willingness to travel (5% of working time)
- Make a difference by joining our great team and global fight against Tuberculosis
- A crisis-proof job in the pharmaceutical industry
- Targeted support and optimal opportunities for further training
- Above-average remuneration with company pension scheme, attractive bonus model, home office allowance, holiday allowance and others
- Attractive employee benefits incl. wellbeing benefits, employee assistance program, private travel health insurance for abroad travels
- Modern office centrally located near Hackerbrücke
- Home office and flexible working hours with possibility to work from abroad within the European Union for up to 2 months / calendar year