Global Medical Writing ManagerIPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
• Employee Care: We care for our employees, who are the ambassadors making a real difference.
• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role:

The Medical Writer Specialist is responsible for the generation of consistently high-quality clinical documentation content and capable of working across multiple accounts and projects seamlessly. And is the scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others.

Key Responsibilities:

Medical Writing responsibilities

• Manage the preparation of regulatory documents e.g. CSRs, briefing documents, meeting requests, Clinical modules.

• Lead Writing/Editing complex Clinical Dossiers/Safety Reports

• Review documents to ensure compliance with documentation quality standards and regulatory requirements.

• Plan and create timelines to produce assigned documents.

Project Delivery

• Able to work across multiple projects and accounts simultaneously.

• Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.

Communication

• Understand the purpose and role of communications in the wider therapy area and commercial landscape.

• Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital).

Qualifications

• Life sciences degree, preferably MSc or PhD

• Strong Medical Writing experience in either a CRO or pharmaceutical company

• Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.

• Experienced writer of clinical protocols (IS and NIS), study reports (IS and NIS), regulatory dossier level documents

• RWE Medical writing experience is an advantage.

• Previous experience in a medical communications agency or industry is also considered.

• English fluency

If you feel that this could be the right next step for you, we would be delighted to engage with your application.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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