Ipsen

Senior Medical Writer

Ipsen

full-time

Posted on:

Location Type: Office

Location: Paris • France

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Job Level

Senior

About the role

  • The Sr MW is responsible for the generation of consistently high-quality clinical documentation content and capable of working across multiple accounts and projects seamlessly.
  • The incumbent is a contributing scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others.
  • In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities.
  • Working with minimal guidance, the incumbent will take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions.
  • Applying project management expertise and contributing to functional excellence through process management, the incumbent will also play a role in guiding other medical writers.
  • Lead Writing/Editing complex Clinical Dossiers
  • Manage the preparation/preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules
  • Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier
  • Plan and create timelines to produce assigned documents
  • Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team
  • Actively contributes to best practices and continuous improvement within the therapeutic Area
  • Represent the group in functional and cross functional initiatives/projects when required
  • Network and share best practices to ensure efficiency and consistency across product teams
  • 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
  • Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested
  • Oversee Medical Writing consultants and vendors and their writing activities to ensure timely and quality deliverables are completed within budget
  • 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
  • Mentor less experienced medical writers.

Requirements

  • Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience
  • Minimum 5 years Medical Writing experience in a pharmaceutical company or equivalent combination of education and experience
  • Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired
  • Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
  • Recognised industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous
  • 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.
Benefits
  • Comply with applicable EHS regulations and procedures.
  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements
  • Participate in mandatory EHS training
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingregulatory document preparationclinical researchstudy designbiostatisticspharmacokineticsproject managementprocess managementquality controldocument review
Soft Skills
communicationmentoringtime managementaccountabilityflexibilitycollaborationleadershipstrategic thinkingproblem-solvingnetworking
Certifications
MScPhDmedical writing qualification