Biotech Regulatory Affairs Specialist
il y a 2 semaines
Novocure Inc. is a leading global commercial-stage oncology company that specializes in developing innovative cancer treatment therapies. The company's flagship product, Optune, is a non-invasive therapy approved for treating adult patients with glioblastoma in the USA, Europe, and Israel.
We are expanding our efforts into several other solid tumor indications, including non-small cell lung cancer, pancreatic cancer, ovarian cancer, and others.
Job DescriptionRole OverviewThis position will serve as local liaison for all healthcare-specific legal and compliance matters in France and Belgium. The focus will be centered around product communications and contracting with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) or Patient Advocacy Groups.
Your Responsibilities:- Provide strategic, healthcare industry-related legal counsel to French and Belgian business stakeholders, primarily in commercial and medical affairs functions.
- Focus on product communication topics such as promotional or scientific materials and HCP, HCO, or Patient Advocacy contracting.
- Liaise with government agencies and trade associations to ensure compliance with applicable regulatory frameworks.
- Participate as legal advisor in various projects such as communication projects or implementations of electronic platforms or tools for products and environments.
- Collaborate with the wider legal and compliance team and stakeholders from other functions to develop solutions for building compliant relationships with HCPs and government officials.
- Provide training on a wide range of issues and best practices related to promotional content and other related fields.
The estimated salary for this role is €80,000 - €110,000 per annum, depending on experience.
RequirementsYour Profile:- A French legal degree and relevant experience in a related field in MedTech/Medical Devices, Pharma, or other healthcare industries.
- Profound experience in review and approval of marketing and scientific materials in France.
- Thorough understanding of applicable regulations based on several years of experience in a similar role.
- Fluency in French and English is required. Any other language is a plus.
- Prior experience working in an international environment is beneficial.
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