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Principal Medical Writer

Philippines, Remote Job ID R0000033395 Category Medical Writing Date Posted 05/16/2025
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Overview

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.

We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Adaptable
  • Communicator
  • Consistent
  • Deadline-oriented
  • Detail-oriented
  • Insightful

About This Role

The Principal Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources. They oversee the end-to-end signal management process, collaborate with client safety science , and adhere to client-defined plans and SOPs. The PMW also contributes to preparing, updating, and managing various safety documents including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports.  This position requires expertise in pharmacovigilance processes and the ability to manage complex safety data. 
They conduct critical appraisal of literature for epidemiological data, develop search strategies, and apply epidemiological methods to support safety evaluations. The role involves generating line listings, maintaining Expected Term Lists, and performing quality reviews of aggregate reports. The specialist manages report distribution, handles safety assessments and affiliate requests, and performs QC of Reference Safety Information for clinical trials. They also update and manage content for Pharmacovigilance manuals, contribute to MedDRA updates, and coordinate meetings related to pharmacovigilance activities.
This role also focuses on training junior staff, managing processes, and acting as a subject matter expert. They will collaborate with clients, identify team concerns, and support senior management in project activities. The position requires strong leadership, communication, and problem-solving skills, balancing mentoring with project management and client relation and requires expertise in pharmacovigilance, strong analytical skills, and the ability to collaborate across functions to ensure comprehensive product safety management across multiple therapeutic areas.

#LI-REMOTE

Potential Career Path

Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.

  • Associate Medical Writer
  • Medical Writer I
  • Medical Writer II
  • Senior Medical Writer
  • Subject Matter Expert
    People Management

Employee Insights

TEAM IMPRESSIONS

Medical Writer posing for picture in front of a piece they wrote Medical Writers team photo
Medical Writers team wearing Parexel t-shirts and posing for a team photo
Employee posing for a picture in front of art Female employee smiling while standing at podium with paper and pen in hand
Three female employees smiling for photo Female employee after finishing a running event Group of female employees posing for photo at conference

WHY MEDICAL WRITERS WORK AT PAREXEL

Learn About Our Culture

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