Principal Medical Writer

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Principal Medical WriterPhilippines, Remote Job ID R Category Medical Writing Date Posted 05/16/2025As 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 develop 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 opportunities, including mentorship, job shadowing, job rotation, stretch assignments, and leadership development. Your growth and promotion are based on global standards and your personal development plan. Success ProfileDo you have these soft skills and interpersonal traits to succeed at Parexel?

AdaptableConsistentDeadline-oriented

Detail-orientedInsightfulAbout This RoleThe Principal Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources. They oversee the entire signal management process, collaborate with client safety science teams, and adhere to client-defined plans and SOPs.

The PMW contributes to preparing, updating, and managing safety documents such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports. This role requires expertise in pharmacovigilance processes and managing complex safety data. Responsibilities include conducting literature appraisal for epidemiological data, developing search strategies, and applying epidemiological methods to safety evaluations.

The role involves generating line listings, maintaining Expected Term Lists, performing quality reviews of reports, managing report distribution, handling safety assessments, and updating pharmacovigilance manuals. The PMW also contributes to MedDRA updates, coordinates meetings, trains junior staff, manages processes, and acts as a subject matter expert. Collaboration with clients and internal teams, along with strong leadership and communication skills, are essential for ensuring comprehensive product safety management across therapeutic areas.

Parexel offers career advancement opportunities for Medical Writers, including technical and managerial tracks, and lateral moves within the organization. Possible career paths include:Associate Medical WriterMedical Writer IMedical Writer IISenior Medical WriterSubject Matter ExpertPeople ManagementEmployee InsightsWhat excites you about being a Medical Writer at Parexel? How were you supported in getting settled at Parexel?

Our mission is to create medical documents that improve patient experiences and make clinical trials more inclusive and patient-focused. Supportive and inclusive environment

We cultivate a culture of inclusion and respect at all levels. Our leaders exemplify these values and maintain a service-oriented mindset.Career growth and development

We promote growth through ongoing training, stretch assignments, and continuous learning opportunities. We also pair experienced Medical Writers with junior team members for mentorship and skill development.Our flexible work arrangements focus on results rather than location or hours, with many Medical Writers working remotely and participating in conferences and gatherings.Diverse projects

Our team works on a variety of therapeutic areas and clinical trial stages, providing broad exposure and continuous learning.Culture of excellence

We prioritize first-time quality and timely project delivery to accelerate treatment availability for patients.Global exposure

Join one of the largest Medical Writing teams in the industry, with over 180 colleagues across four continents. Our experienced writers share extensive industry insights, supporting both seasoned professionals and newcomers to the field.