Medical Writing Manager H/F
Groupe Ipsen
Les Ulis Courtaboeuf, France
il y a 26j

Purpose of the position

  • To ensure that all medical writing documents prepared for assigned Clinical Research Programs within Ipsen R&D are prepared in accordance within rigorous, objective and informative medical writing procedures and processes.
  • To lead the Medical Writing activities for US, European or other regulatory submissions as assigned.
  • To ensure documents for assigned clinical trials are prepared, reviewed, and approved in a quality, timely and accurate manner such that the data presented will withstand examination by regulatory bodies.
  • To support the full use of the Electronic Document Management System (EDMS) for all assigned products within the Ipsen Group.
  • Primary Activities

    Main responsibilities and tasks

    Medical Writing

  • To plan, schedule and track all assigned medical writing activities in close cooperation with the teams to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports and forecasts to management.
  • To ensure that assigned protocols, clinical study reports and investigator brochures and other documents as appropriate, are developed with medical writing input as early as possible.
  • To provide disease area guidance to internal and external writers for assigned projects
  • To undertake assigned medical writing projects within Drug Development including interim and final integrated study reports, and where appropriate, integrated clinical summaries, protocols or other documents.
  • To develop awareness of the benefits of the EDMS in the preparation of protocols, clinical study reports and investigator brochures within Drug Development
  • To interact with other groups in order to provide an efficient, effective and timely medical writing service. Groups will include Clinical Development Teams, Study Teams and other groups as appropriate.
  • To complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the Ipsen Group.
  • Project Deliverables

  • To take responsibility for ensuring that assigned medical writing deliverables meet the project
  • specifications, and that they are produced within the timelines to defined quality, and content standards.
  • To take responsibility as a medical writing adviser for project teams across the assigned disease area.
  • Supplier Management

  • To take responsibility for ensuring that outsourcing of assigned medical writing projects is conducted after a thorough evaluation of the capabilities of the CRO / freelancer concerned, that the deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • To supervise assigned medical writing projects contracted to third party suppliers, including interim and final integrated study reports and, where appropriate, integrated clinical summaries, protocols or other documents.
  • General

  • To maintain awareness of current issues and developments in medical writing, particularly those impaction the assigned disease area.
  • To perform any other activity as may reasonably be required from time to time.
  • Candidate Profile

    Experience / Qualifications

  • Ideal : Relevant MSc or PhD
  • Minimum : Life sciences degree or equivalent
  • Proven track record of medical writing within a relevant therapy area
  • Awareness and understanding of clinical / pre-clinical pharmaceutical research and development arena
  • Demonstrated ability to assimilate knowledge and understanding of a new therapeutic area
  • Evidence of having worked on summary level documents such as investigator brochures and regulatory submissions
  • Good understanding of GCP, the clinical development process and of ICH guidelines
  • Well-developed writing, time management, communication, presentation, analytical and interpersonal skills
  • Proven ability to manage multiple projects within challenging timeframes
  • Ability to present information in a clear, accurate, logical and non-technical manner
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