Clinical Affairs Specialist
il y a 7 jours
Ecolab Healthcare strives to be the global expert in delivering cleaner, safer and healthier environment for our hospital customers. Our work directly impacts the quality of patients care and their family's care.
Within our dynamic and collaborative environment, the Healthcare Marketing team plays a significant role in making the Healthcare vision a reality and has broad exposure to the business. The marketing function is at the core of the business, and fully aligned with the countries.
The Clinical Affairs Associate is a key role in the healthcare marketing. This person will have a proactive role in the implementation of the healthcare Europe clinical strategy and will contribute to its success. This is a cross-functional role, requiring significant collaboration with other function (EU and local marketing, RD&E, RA…) and sales teams, and extensive work with customers, societies and partners.
The successful candidate will demonstrate strong communication and collaboration skills, passion for customers and for providing a healthier healthcare environment, and commitment in achieving goals.
The position will report directly to the Healthcare Clinical Affairs Leader for Europe.
Main responsibilities:
Define the claims of medicinal products and the clinical strategy in line with product development objectives and regulatory requirements.
Design, plan and supervise clinical studies (pre- and post-market).
Draft study protocols, monitoring plans and clinical reports.
Ensure compliance of the portfolio claimset with clinical data and with local and international regulations and guidelines for medical devices and medicinal products
Participate in the drafting of regulatory dossiers
Ensure scientific intelligence and monitoring in the field of medical devices and medicinal products in relation with our portofolio.
Contribute to the training of internal teams on clinical aspects.
Support local teams (marketing and sales) on customer request to improve business growth and Ecolab expertise recognition
Collaborate with critical function: EU marketing team, RD&E, Sales teams, Regulatory team ; and with external providers
Basic qualifications:
Master's degree in clinical research, pharmacy, medicine, nurse.
Proven experience (5+ years) in clinical trial management, ideally in the medicinal product or medical device sector.
In-depth knowledge of clinical regulations (GCP etc.).
Excellent project management and communication skills.
Ability to work in a multicultural and interdisciplinary environment.
Experience working in a matrix environment
Fluency in English
Preferred qualifications:
Preferred work location is in Italy (our office is located at Vimercate (MB)) or in France (our office is based in Lille)
Proven ability to work independently and navigate in matrix organization to achieve business results
Ability to demonstrate leadership on project management
Proven business acumen
Good oral and written communication skills and proven experience on providing efficient customer experience
Demonstrated rigorous and attention to details skills
Experience creating customer-facing presentations
Ability to be proactive and adaptable depending on company/team goals
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