Affaires Reglementaires jobs in France

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Onsite Location(s):

Île-de-France, FR

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

The French Scientific Affairs & Real-World Evidence (RWE) Manager will be part of the EMEA RWE team within the Health Economic and Market Access (HEMA) department at Boston Scientific.

The French Scientific Affairs & Real-World Evidence (RWE) Manager will contribute to the EMEA RWE strategy with the following key responsibilities:

1. Initiating and overseeing post-reimbursement studies across all BSC therapies as per French authorities’ requirements,

2. Reviewing clinical data point and claims presented in commercial and promotional materials in France,

3. Contribute to the HEMA RWE strategy across BSC therapies in EMEA.

The ideal candidate has a strong background in RWE research and in-depth knowledge of the French regulatory and reimbursement landscape.

Responsibilities:

· Interface, educate, and gain insights from external stakeholders, including scientific societies, key opinion leaders, local decision makers, reimbursement stakeholders, and patient advocacy groups on ongoing PRS.

· Strong partnership, alignment and collaboration with the French HEMA Country Head and the French Health Economics and Market Access (HEMA) team.

· Collaborate with internal cross-functional teams (HEMA, Medical Affairs, Marketing, Regulatory) and external stakeholders (CROs, investigators, ethics committees) to ensure successful study execution.

· Lead the planning, set up, execution, and management of post-reimbursement studies in France required by French health authorities (e.g., CNEDiMTS (HAS)).

· Advice during the creation of the scientific committee for the post reimbursement studies.

· Develop RWE study protocols, support site selection strategy, timelines, budgets, and ethics submissions in collaboration with local investigators, CROs, and internal stakeholders.

· Act as the liaison between the company and health authorities (e.g., HAS) for matters related to post reimbursement studies.

· Coordinate data collection and reporting for post reimbursement studies or RWE retrospective studies to support continued reimbursement and EMEA evidence generation strategy across therapies.

· Ensure compliance with French regulations, Good Clinical Practice (GCP), and internal SOPs.

· Support HEMA local for the submission of study results to relevant French health authorities.

· Provide support to HEMA teams on clinical review of reimbursement dossiers and other documentation needed to drive market access in France and in the EMEA region.

· Support health economics and outcome research (HEOR) studies to generate data that can be analyzed to support market access and reimbursement in collaboration with colleagues dedicated to HEOR.

Clinical Review of French Commercial Materials

· Support internal reviews and approvals as the clinical expert for reviewing promotional content specific to France to ensure accurate and compliant use of clinical data as per French ANSM requirements.

· Collaborate with Marketing, Regulatory, Compliance, and Legal teams to ensure materials meet French standards.

· Ensure that all data cited in marketing materials are scientifically valid, appropriately referenced, and in line with local regulatory guidance and company policy.

· Maintain an up-to-date understanding of relevant clinical literature and competitor data.

Real World Evidence Generation

· Support EMEA RWE studies, including study design, study protocols preparation, management and collection of real-world data (RWD) through different data sources such as claims databases, patient-reported outcomes, electronic health information, digital health apps, wearable devices and more.

· Assists in publication activities, including preparation and review of abstracts and manuscripts, publication strategy development and collaboration with authors as needed.

· Contribute to the EMEA evidence generation strategy.

Qualifications:

· Advanced scientific degree in Life Sciences, Biomedical Engineering, Pharmacy, Medicine, or related scientific field (MSc, PharmD, PhD, or equivalent).

· Minimum 5 years of experience in real-world evidence research, post-market studies, and post reimbursement studies in medical devices or pharma.

· Proven experience with French regulatory and reimbursement systems (CNEDiMTS, HAS) and with reimbursement dossiers.

· Experience reviewing promotional or commercial materials for clinical accuracy is preferred.

· Strong strategic thinking and leadership skills with the ability to influence across multiple stakeholders within and outside the organization.

· Excellent presentation and communication skills, and collaborative approach.

· Excellent project management and cross-functional collaboration skills.

· Strong analytical skills and ability to interpret complex clinical data.

· Generate and champion new ideas and approaches.

· Fluent in French and English (spoken and written).

Travel : up to 30%

Work Mode : Hybrid

Requisition ID:609710

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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