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Manager Medical / Scientific Writing

Publié il y a 2 semaines par PharmaLex
Courbevoie, Île-de-France
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Description du poste

Your Job

  • Writing of deliverables in accordance with the applicable regulations in force and in compliance with the commitments made to clients
  • Manage the writing of dossiers in full autonomy in coordination with Project Manager and rest of the team
  • Act as Lead Medical Writer or support the Lead MW
  • Participate in local, regional or multi-countries or cross-VDCs projects
  • Identify additional resource/ staffing needs and report to Management
  • Liaise with clients and setup recurrent meetings with clients/counterparts
  • Stay up to date with scientific developments relevant for the portfolio of the clients
  • Participate in Gap Analysis aimed at identifying deficiencies in draft/old dossiers developed by Clients
  • Contribute to the development of Proposals for clients incl. a Medical/Scientific Writing scope of work
  • As applicable, manage a team (mentoring, personal development, annual performance reviews, holidays, etc.)
  • Ensure compliance with deadlines and the quality of the files submitted to customers
  • Contribute to regulatory intelligence and maintain high level of knowledge in MW activities

    • Your Profile

  • University degree in pharmacy or other discipline in Life sciences
  • Minimum 10 years of professional experience, excellent knowledge of Drug Development and related Agencies requirements
  • 3 to 5 years of professional experience as Medical/Scientific Writer including project management experience
  • Strong knowledge of European & US regulatory requirements for medicinal products
  • Fluent in English both written and spoken and French (spoken, possibly as a 2nd language)
  • Ability to manage and lead a project in full autonomy 
  • Management of teams in an international matrix organization and excellent team player
  • Very good written and spoken communication skills with both internal and external stakeholders
  • Ability to develop and deliver presentations
  • Ability to analyse information rapidly and to identify and offer solutions to problems
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Business and customer oriented
  • Good knowledge of the Microsoft Office package
    • Il y a 2 semaines
    Je postule

    Je crée mon compte

    Je souhaite que mon CV soit visible pour les recruteurs afin qu'ils puissent me contacter directement