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 Writing Manager is an effective team leader capable of working efficiently with minimal oversight and direction within an asset centric matrix organization. And is the scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others.

Key Responsibilities:

Leadership / Management

• Proactively collaborates within their assigned study/project teams to ensure all medical writing deliverables for a given study are prospectively identified, included in the project plan, adequately resourced and are delivered on time and to quality expectations.
• Directly oversee, develop, and manage medical writers or medical writing service providers; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers.
• Contribute to building capabilities and technical skills across the medical writing department.
• Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensure team awareness of developments impacting medical writing standards.
• Determine resource needs based on workload and project priorities and communicate to the Head of Biometry in a timely fashion.

Main Medical Writing responsibilities

• Lead by example, serving as an expert document author and directing and supervising the authoring of documents within the framework of and in compliance with ICH-GCP, applicable regulatory guidelines.
• Proactively collaborate with study teams (global and local) and other functions including but not limited to therapeutic area, regulatory and pharmacovigilance, to ensure assigned documents are developed with medical writer input as early as possible.
• Lead document strategies and messages in a collaborative way with relevant project team subject matter experts.
• Reviews documents to ensure compliance with documentation quality standards and regulatory requirements.
• When leading a team of other authors (internal or external), be accountable for timely delivery of high quality, fit-for-purpose documents to the study team.

Project Deliverables

• Plan, schedule and track all assigned medical writing activities in close cooperation with clinical operations and medical/regulatory study team members.
• Deliver assigned documents on or before deadline, promptly alerting study / project teams and Head of Biometry of any anticipated delays, information gaps or potential shortcomings in quality.
• Identify Medical Writing process improvement opportunities and contribute to development /maintenance of operating procedures to aim for excellence in execution and delivery.

Qualifications

• Life sciences degree, preferably MSc or PhD

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

• RWE Medical writing experience.

• 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.

• Ability to present information in a clear, accurate, logical and non-technical manner. Solid understanding of the

  target audience needs.

• Committed to data integrity and reporting standards.

• Demonstrated ability to assimilate knowledge and understanding of a new therapeutic area.

• Experience managing medical writing projects within a predominately outsourced model, or leading remote based

  medical writing teams (internal or external).

• Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.

• 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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