Group Medical Evidence Generation Lead Milano

Group Medical Evidence Generation Lead
Milano
Lombardia, Milano

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4, 500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve.

We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple.

We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege.

Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop.

Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati.

Unlocking the full potential of life. Job PurposeResponsible for keeping oversight of evidence generation activities across the two BUs and all therapeutic areas.

This role supervises the real-world evidence (RWE) data generation and communication strategy/plans. Facilitate the implementation of a strong culture of strategic evidence generation. Ensure brands in development and in markets have a robust evidence base, including patients and outcomes data when possible, to support their value and safety. Bridge the gap between clinical research, real-world evidence, and market access, contributing to the successful development and commercialization of company's products. As a subject matter expert, work closely with Medical Affairs, R&D, Marketing, Market Access and other relevant functions, as appropriate, to co-create and execute evidence generation strategies and plans that align with regulatory requirements, market access needs, and the overall product development and brands communication plans. Design, coordinate, and oversee the generation of evidence, including outcome research, throughout the product lifecycle. Identifies global and local opportunities for RWE. Key ResponsibilitiesEvidence Generation Strategy/Plans: Develop and implement evidence generation strategies and plans for medical products, ensuring they meet regulatory requirements and market access needs, in line with BU/Franchise strategy and priorities. KOL / External stakeholders partnership: in collaboration with medical teams, engage with key scientific leaders / Societies and other relevant external stakeholders (healthcare professionals, digital, administrative) to identify unmet medical need and research gaps and opportunities.

Identify opportunities for global and local evidence generation in priority areas. Real-world Evidence: Drive internal RWE awareness and trainings to enhance local capabilities in generating real-world evidence and local publications.

Utilize real-world data sources (e. g. , electronic health records, claims data), and plan non-interventional trials (NIS) and other types of studies to generate evidence on product effectiveness, safety, and value in real-world clinical settings. Health Economics and Outcomes Research (HEOR): In collaboration with market access teams, design and conduct HEOR studies to assess the economic impact and patient outcomes associated with the product.

This may include cost-effectiveness and budget impact analyses. Marketing and Market Access Support: Collaborate with marketing and market access (and other as appropriate) teams, both at corporate, franchise and local level, to provide evidence needed for reimbursement and market adoption of the product. Data Analytics: Apply advanced data analytics techniques to analyse and interpret complex healthcare data, supporting evidence generation efforts. Regulatory Compliance: Ensure that evidence generation activities adhere to clinical and regulatory guidelines and requirements set forth by health authorities (e. g. , FDA, EMA). Publication and Communication: Drive the development of scientific publications, presentations, and dossiers that communicate evidence to internal and external stakeholders. Cross-functional Collaboration: Work closely with medical affairs, clinical development, regulatory affairs, and other relevant teams to align evidence generation efforts with overall product strategy and priorities. Medical governance and Compliance: Ensure activities are done in compliance with company's corporate standards, industry regulations, guidelines, and ethical standards. Required EducationAdvanced degree (Ph. D. , M. D. , Pharm. D. , or equivalent) in a relevant field such as epidemiology, health economics, clinical research, or a related discipline. Required Skills and ExperienceAt least 7 years of experience in evidence generation within the healthcare or pharmaceutical industry. Solid knowledge of medical affairs, clinical trial design, real-world evidence, health economics, and regulatory requirements. Solid understanding of data analysis and statistical methods. Effective communication and presentation as well as leadership skills. Knowledge of relevant software and tools for evidence generation and analysis. Required LanguagesFluency in written and spoken English. At Recordati we believe in people!

Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion.

We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer.

We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you #J-18808-Ljbffr