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Pharmaceutical Affairs Manager
Il y a 2 mois
Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
To support our team in Paris, we are looking for a
Pharmaceutical Affairs Manager (legal/regulatory)
In this role as Pharmaceutical Affairs Manager you will be serving as a local liaison for all healthcare specific regulatory matters in France and Belgium. The focus for this role is centered around product communications and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) or Patient Advocacy Groups.
You will be working closely with your local business partners and provide support and advisory related to the product communication framework of medical devices, including promotional and scientific materials in France and Belgium.
Your responsibilities:
- Working closely with business stakeholders to ensure timely and effective regulatory, legal and compliance guidance on strategic and tactical matters.
- Provide support related to product communication regulatory framework of CE marked medical devices in France and Belgium. Including promotional and scientific materials and communication on human health and diseases.
- Participate as advisor in digital communication projects and implementation of electronic platforms and tools and provide appropriate support.
- Anticipate risks and requests from authorities and act accordingly.
- Close collaboration with the wider Legal and Compliance team, as well as Commercial and Medical Affairs team members to develop solutions for building compliant relationships with HCPs and government officials.
- Coordinate and execute transparency reporting (and other related tasks) for Novocure’s French and Belgian Operations, as well as managing the implementation and future operation of the new “Charter of Information on Medical Devices”.
- Provide training on a wide range of issues related to promotional content, best practices etc.
- Leading on internal and external audits.
Your profile:
- “Docteur en pharmacie” or other relevant university degree and relevant experience in a related field in MedTech/Medical Devices, Pharma or other healthcare industries is required.
- 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.
We are looking forward to receive your application through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.
