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- Aufgaben: Create and manage clinical and regulatory documents for a top pharma company.
- Arbeitgeber: Join ICON, the world's largest clinical research organization with healthcare intelligence.
- Mitarbeitervorteile: Enjoy stable employment while working closely with industry leaders.
- Warum dieser Job: Make an impact in healthcare by delivering best-in-class regulatory documents.
- Gewünschte Qualifikationen: Bachelor's degree required; 3-5 years of medical writing experience preferred.
- Andere Informationen: Collaborate with QC personnel and publishing specialists for document preparation.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Social network you want to login/join with: As a Senior Medical Writer, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As a Senior Medical Writer, you will be supporting a Top-5 pharma company. You have the chance to help our customer deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client. Responsibilities: Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas. Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies. Act as the primary contact for the study team in relation to the preparation and timelines (including planning) of assigned documents. Facilitate the review of the documents and ensure that documents are submission-ready and finally approved. When preparing documents, you will be directly in contact with QC personnel and publishing specialists who support you in document preparation. Minimum Requirements: Minimum requirement of a bachelor’s degree; Master\’s degree preferred. 3-5 years of Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledge. Strong writing skills and the ability to convert scientific data into clear, scientifically sound, well-structured messages. Proficient in independently writing several types of clinical/regulatory documents (mainly CSRs, Protocols) including leading creation, coordination of the authoring functions, facilitation of the review of the documents, and ensuring that documents are submission-ready and finally approved. #J-18808-Ljbffr
Senior Medical Writer, null Arbeitgeber: Whatjobs
Kontaktperson:
Whatjobs HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Medical Writer, null
✨Tip Number 1
Familiarize yourself with the specific types of clinical and regulatory documents mentioned in the job description, such as Clinical Study Protocols and Clinical Study Reports. Understanding the nuances of these documents will help you demonstrate your expertise during the interview.
✨Tip Number 2
Highlight your experience with lean writing strategies in your discussions. Being able to articulate how you've applied these strategies in past roles can set you apart from other candidates.
✨Tip Number 3
Prepare to discuss your collaboration with cross-functional teams, especially with Principal Medical Writers and QC personnel. Sharing specific examples of successful teamwork will showcase your ability to work effectively in a collaborative environment.
✨Tip Number 4
Research the Top-5 pharma company you'll be supporting. Understanding their therapeutic areas and recent developments can give you an edge in the interview, showing your genuine interest and preparedness for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Medical Writer, null
Tipps für deine Bewerbung 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior Medical Writer. Familiarize yourself with the types of documents you'll be producing and the importance of regulatory submissions.
Tailor Your CV: Highlight your relevant experience in medical writing and any specific projects that align with the job description. Emphasize your ability to produce clinical study documents and your experience with regulatory submissions.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about medical writing and how your background makes you a perfect fit for this role. Mention your experience with Phase 1 to Phase 3 studies and your proficiency in lean writing strategies.
Proofread Your Application: Ensure that your application is free from grammatical errors and typos. A well-written application reflects your attention to detail, which is crucial for a Senior Medical Writer.
Wie du dich auf ein Vorstellungsgespräch bei Whatjobs vorbereitest
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are crucial. Be prepared to discuss your previous work and provide examples of clinical and regulatory documents you've authored. Highlight how you transformed complex data into clear, concise messages.
✨Understand the Regulatory Landscape
Familiarize yourself with the regulatory requirements relevant to clinical documents. During the interview, demonstrate your knowledge of these regulations and how they influence document preparation and submission processes.
✨Discuss Collaboration Experience
Since you'll be working closely with Principal Medical Writers and study teams, share examples of successful collaborations from your past roles. Emphasize your ability to coordinate with various stakeholders to ensure timely and accurate document delivery.
✨Prepare for Technical Questions
Expect technical questions related to medical writing and clinical research. Brush up on your knowledge of clinical study protocols and reports, and be ready to discuss your approach to analyzing and interpreting data for document creation.
