Medical Writer Specialist

Ipsen•Paris, TX

61d•Remote

About The Position

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company? 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. 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. #LI-HOMEBASED Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. Soyons nous-même

Requirements

Life sciences degree, preferably MSc or PhD
Minimum 5 years 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
English fluency

Nice To Haves

RWE Medical writing experience is an advantage.
Previous experience in a medical communications agency or industry is also considered.

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.
Able to work across multiple projects and accounts simultaneously.
Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
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).

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