Medical Writting Associate F/m - Boulogne-Billancourt, France - Ipsen Pharma (SAS)
Description
Main responsibilities / job expectations
Main Medical Writing responsibilities
- Manages the preparation of regulatory documents e.g. CSRs, briefing documents, meeting requests, Clinical modules.
- Leads Writing/Editing complex Clinical Dossiers/Safety Reports
- Reviews documents to ensure compliance with documentation quality standards and regulatory requirements.
- Plans and creates timelines to produce assigned documents.
- Ensures proper planning and resourcing of all documents assigned to Writing/Editing Team.
- Actively contributes to best practices and continuous improvement within the therapeutic Area.
- Represents the group in functional and cross functional initiatives/projects when required.
- Networks and shares best practices to ensure efficiency and consistency across product teams.
Project Delivery
- Able to work across multiple projects and accounts simultaneously.
- Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
- Adhere to the quality control process and ensure all work produced has gone through the correct internal review process.
- Demonstrate a good understanding of project management and resource planning.
- Maintain a working knowledge of pharmaceutical industry standards and compliance.
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).
- Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate. Link this with any potential new business opportunities where applicable.
- Provide regular feedback to senior teams across accounts and projects.
Knowledge, abilities & experience
Education / Certifications:
- Minimum of a master's degree in life sciences, medicine, pharmacy or related disciple
- Life sciences degree, preferably MSc or PhD
Experience:
- Minimum 5 years Medical Writing experience in either a CRO or pharmaceutical company
- RWE Medical writing experience is an advantage.
- 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 etc.
- Proficient in using Microsoft Office programmes (e.g. PowerPoint, Excel, etc.)
- Have an excellent command of the English language in both written and verbal communications desirable
- Previous experience in a medical communications agency or industry would be advantageous
- A keen interest in working and developing scientific expertise across a range of therapy areas
- Flexible approach to working, with the ability to reprioritise and work under pressure when needed
- Excellent time management skills and demonstrated ability to forecast and manage workload
Languages:
- English (Excellent level both written and verbal)
Key Technical Competencies Required
- Experience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, and Regulatory Submission Modules.
- Able to manage coordination responsibilities beyond writing individual documents, e.g., timelines, reviews and submissions
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