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Principal Medical Writer

, Philippines Date posted 05/16/2025 Job ID R0000033395

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Detail-Oriented
  • Deadline-Oriented
  • Communicator
  • Organized
  • Versatile
  • Tech-Savvy

  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
    knowledgeable, and it is easy to communicate with other staff."

    Christine, Medical Writer II

  • "Parexel makes it easy to communicate and interact with each other, which allows
    me access to expertise and knowledge beyond my own."

    Kristy, Associate Manager

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Work-life Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Home based

    Love where you work, and work where you love.

  • Variety

    Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Responsibilities

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.

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