Medical Writer II (FSP)

Medical Writer (FSP)

Parexel FSP is currently seeking for a Medical Writer position in Shanghai, China

Working as a Medical Writer at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

If impact, flexibility and career development appeal to you, Parexel FSP could be your next home.

Some Specifics About This Advertised Role The job involves working in local and/or global, cross-functional trial and/or project teams, and dealing with complex scientific issues in clinical development programs.The job requires the ability to critically assess, interpret, and describe clinical data and to resolve conflicting reviewer’s feedback.Additional complexity is introduced by external providers, and working in different regulatory contexts (e.g. US, EU, China and/or Taiwan). The job requires handling numerous complex tasks simultaneously.Responsible for the preparation of clinical documents on project and/or trial level required for advancing clinical development programs. This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the trial and/or project teams.Requires proactive and continuous cross-functional coordination to ensure timely and successful document finalization.Ensure quality of clinical documents assigned to external providers by appropriate oversight and training. Contribute to appropriate budget planning and cost control.Develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio. Share knowledge with other medical writers (e.g. by giving presentations in team or group meetings).Advance MW standards by contributing to process improvement initiatives and working groups with cross functional impact.

Here are a few requirements specific to this role: Master or Doctoral degree in Pharmacy, Medicine or Life Science.Previous experience in scientific and/or regulatory medical writing.Ability to independently and effectively communicate complex clinical information in writing for the target audiences; scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data;Understanding of the clinical development process and relevant global and/or local regulatory guidelines.Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers, ability to manage parallel tasks and variable workload, strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, ability to manage conflicting reviewer’s comments, and presentation skills;Ability to contribute to process improvements; proficiency in word processing and presentation software; excellent written and verbal English and Mandarin skills.

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