Medical Writting Associate F/m - Boulogne-Billancourt, France - Ipsen Pharma (SAS)

Ipsen Pharma (SAS)
Ipsen Pharma (SAS)
Entreprise vérifiée
Boulogne-Billancourt, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
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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