PSanthera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need. /ppCome and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as : /ppMedical Affairs Director, Italy /ppbScope of Work /b /ppThe Medical Affairs Director, Italy reports directly to the General Manager of Italy, with a dotted line to the Head of Medical Affairs EU ROW. This role is part of the Italian management team and collaborates closely with all other functions based in Italy, as well as affiliated functions such as Clinical Development, Medical Affairs, Marketing, Commercial, Market Access, and others. The overall scope of the role : /pulliProvide effective strategic, scientific and medical leadership /liliLine management of medical team (when in place) /liliDevelop and lead implementation of effective and aligned Italy Medical Affairs plans /liliEngage with scientific leaders in relevant therapy areas to raise awareness, provide relevant information and foster scientific exchanges /liliDemonstrate effective collaboration and share best practices between Italy, other countries, and HQ /li /ulpbKey Responsibilities /b /pulliRecruit, develop and maintain a high performing medical affairs team (as needed) /liliIdentify strategic medical activities to support the company goals /liliAlign the Italy Medical Affairs and publication plans to global plans /liliPlan and deliver effective and aligned medical communications, congress and educational plans /liliDeliver tactics on budget and on time /liliDevelop, oversee and implement Italy scientific / clinical leaders and KOL development plan /liliSupport local patient advocacy group engagement plan as aligned with Patient Advocacy Group Programme Manager and HQ /liliEffectively support market access projects with regards to local value and reimbursement dossiers and relevant medical practices /liliContribute to and support, as needed, HQ-led Medical Affairs projects such as product / therapy training platforms, local events, congresses etc. /liliEnsure adherence to Santhera SOPs and Italy country compliance codes of practice, developing local SOPs as necessary /liliAct as Italian compliance champion, applying knowledge of country codes to optimise Italy activities /liliEnsure effective support and collaboration between Santhera medical affairs team and commercial colleagues /liliCollaborate and contribute to high priority EU / global projects /liliComply to all relevant SOPs /liliDeliver timely and compliant review and approval of marketing and medical materials /liliAct as the senior medical representative of the company at global projects /li /ulpbRequired Qualifications Experience /b /pulliBachelor’s degree in a scientific field; licensed Doctor (MD), Pharmacist (PharmD) or holder of an equivalent advanced scientific degree /liliMinimum of 10 years’ proven experience in medical affairs, with a strong focus on product launches and life cycle management, and in-depth knowledge of regulatory and compliance requirements in Italy /liliExperience in rare diseases, RD, and / or clinical work within a hospital or patient association preferred /liliExperience in the neuromuscular disease landscape or related therapeutic areas preferred, with familiarity with relevant clinical trial methodologies /liliPrior experience in leading and managing teams, including line management responsibilities /liliWillingness to travel up to 50% as required /liliAbility to build and maintain strong relationships with key opinion leaders, healthcare professionals, and internal stakeholders /liliExcellent planning and organisational skills /liliStrong strategic vision with a business focus; able to shift between detailed analytical work and strategic thinking /liliProactive and results-oriented, with a demonstrated ability to drive initiatives to successful completion /liliNative Italian speaker with outstanding written and verbal communication and presentation skills /liliProven ability to work independently and collaboratively in a dynamic, fast-paced matrix environment /liliResilient and perseverant, with the ability to navigate ambiguity, take appropriate risks, and make sound decisions in an entrepreneurial business environment /liliAdaptable and open-minded with a solutions-oriented and creative mindset /li /ulpIf you are interested in a multicultural, challenging, and innovative working environment and your profile matches our requirements, we look forward to receiving your online application in English via LinkedIn or email at /ppuNote for agencies : /u Recruitment agencies are kindly requested to refrain from sending unsolicited CVs to Santhera. /p #J-18808-Ljbffr