Emplois actuels liés à Gra Rare Diseases Apprentice - Paris er - Forums Talents Handicap
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Key Account Manager Paris, Idf Et Nord de La France
il y a 7 jours
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Regulatory Affairs Manager
il y a 2 semaines
Paris, France Perrigo Temps plein**Description générale**: **_ HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and...
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Global Medical Director, Rare Diseases
il y a 2 semaines
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Junior Intern in Medical Department
il y a 1 semaine
Paris, France Ascendis Pharma Temps pleinAre you eager to contribute to improving the lives of patients living with rare diseases? Would you like to gain hands-on experience in product management and medical marketing within the pharmaceutical industry? If so, now is your chance to join Ascendis Pharma as our new Junior Intern in France. At our headquarters in Hellerup, Denmark, research facilities...
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Junior Intern in Medical Department
il y a 7 jours
Paris, France Ascendis Pharma Temps pleinAre you eager to contribute to improving the lives of patients living with rare diseases? Would you like to gain hands-on experience in product management and medical marketing within the pharmaceutical industry?_ - If so, now is your chance to join Ascendis Pharma as our new Junior Intern in France._ At our headquarters in Hellerup, Denmark, research...
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Stagiaire Translational Sciences Rare diseases/Neurosciences
il y a 5 jours
Paris, Île-de-France Ipsen Temps pleinTitle:Stagiaire Translational Sciences Rare diseases/NeurosciencesCompany:Ipsen Innovation (SAS)About Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S.,...
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Adjoint à La Coordination European Rare Diseases Research Alliance
il y a 1 semaine
Paris, France Inserm Temps plein**Description entreprise**: L’Inserm est le seul organisme public français entièrement dédié à la recherche biologique, médicale et en santé des populations. Il dispose de laboratoires de recherche sur l’ensemble du territoire, regroupés en 12 Délégations Régionales. Notre institut réunit 15 000 chercheurs, ingénieurs, techniciens et...
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Stagiaire Translational Sciences Rare diseases/Neurosciences
il y a 5 jours
Paris, Île-de-France IPSEN Temps pleinJob Title: Master's Student – Proteomics & Pathway Analysis InternshipDuration: 6 monthsLocation: BalardDepartment: Early Development/Translational SciencesReports to: Luis Briseno-Roa (coll. Jacquie Maignel)OverviewWe are seeking a motivated Master's student to join our team for a 6-month internship focused on supporting the analysis of a proteomic study...
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Eu Omnichannel Content Lead Rare
il y a 7 jours
Paris, France UCB Temps plein**Make your mark for patients** To strengthen our **R&E EU** department we are looking for a talented profile to fill the position of**:EU Omnichannel Content Lead Rare & Epilepsy - Paris, France.** **About the role** **The EU Omnichannel Content Lead for Rare & Epilepsy** is responsible for developing and implementing the omnichannel strategy for Rare &...
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Bilingual Team Assistant
il y a 1 semaine
Paris, France Perrigo Temps plein**Description Overview**: HRA Pharma Rare Diseases is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and Adrenal...
Gra Rare Diseases Apprentice
il y a 2 semaines
The position offers a 12 months apprenticeship in Global Regulatory Affairs, TA (oncology, neurology or rare disease)
- To support global regulatory development and registration plans supporting commercialization, both pertaining to Europe/US/Canada/China/Japan.
- Take part of strategic and operational tasks/discussions for early and/or late stage programs
- Regulatory coordination
- Contributes to the drafting and implementation of the regulatory strategy (e.g. Regulatory Strategy Documents) for specific projects, ensures that the needs for his/her region are adequately reflected.
- Supports the coordination of the preparation with relevant functions and the assembly of regulatory documentation to be submitted according to the strategy validated.
- Contributes to critical and constructive review of regulatory dossiers (MAA/NDA, New indication, CTA, special designation, pediatric development, etc.)
- Ensures quality authoring of core-administrative parts of submission packages.
- Works on the content of regulatory submission dossiers in collaboration with GRA Director and approves change control.
- Ensures adequate planning and timelines management/adjustment depending on the deliverable.
- Attends/Drives cross functional meetings with Project team depending on deliverables
- Supports marketing authorization procedures with support from GRA Director and Local Regulatory Affairs (LRAs) when applicable.
- Participates to the preparation of regulatory agencies consultations (e.g. EMA or national scientific Advice, protocol assistance, FDA meetings, Health Canada meetings).
- Participates to the coordination of the responses of questions from authorities.
- Ensures adequate coordination of regulatory activities through reliable liaison with LRAs.
- Maintains a continuous flow of information with LRAs depending on the progress of projects.
- Strong collaboration with CMC Regulatory/ Regulatory excellence and Regulatory operations
- Interaction with Regulatory Oncology/Neurology therapeutic areas and knowledge sharing
- Participates to maintaining good relationships with working partner when applicable (CROs, vendors, development partners)
- Compliance
- Operates according to Regulatory and Ipsen SOPs
- Ensures that registration status is adequately reported in VREG (regulatory tracking tool) through data entry.
- Regulatory Intelligence
- Contributes to Regulatory intelligence, by tracking and analysing the evolution of regulations relating to his/her areas;
- Informs the relevant departments and answers their questions.
- GRA and GRA Trainee Academy active team member
- Attend/Present at GRA knowledge sharing meetings
- Attend Ipsen internal events (Presentations, external speakers, forums, webinars, celebrations)
- Ensures adequate reporting of his/her activities and participates to various meetings depending on project assignments
- Be an active member of the GRA Trainee Academy (specific program designed to provide a framework for the GRQ interns and apprentices only): attending proposed trainings, prepare webcast, share experience, build network, site visits (if possible), get exposure to senior management. Provide feedback and participate in Trainee Academy further development and visibility.
- Key technical competencies
- Excellent written and oral communication skills and delivers all communication with clarity and impact.
- Ability to influence others and act as a team player
- Ability to demonstrate problem-solving skills and intellectual curiosity
