What does a Medical Writer do?

Explore the responsibilities, collaboration, and growth opportunities of a Medical Writer in the Clinical Research Industry

Medical Writers at Parexel play a crucial role in communicating complex scientific data to various stakeholders in the clinical research process. They bridge the gap between planning and execution of trials, scientific findings and regulatory requirements, ensuring clear and compliant documentation. By producing high-quality, patient-centered content, Medical Writers support Parexel's mission to advance healthcare and bring innovative treatments to patients faster.

Browse our open Medical Writer positions or learn more about a day in the life of a Medical Writer.

Q: What are the job responsibilities of a Medical Writer?

A: Regulatory Medical Writers at Parexel are responsible for preparing and managing various safety and regulatory documents, including:

• Patient narratives
• Investigator Brochures
• Clinical Study Protocols
• Informed Consent Forms
• Clinical Study Reports (CSRs)
• Clinical Technical Document (CTD) Modules for Safety, Efficacy, and Clinical Overview
• Health Authority Responses
• Periodic Safety Update Reports (PSURs)
• Benefit-Risk Evaluations (PBRERs)
• Risk Management Plans (RMPs)

Required skills include:

• Ensuring compliance with current global regulatory requirements
• Adhering to client timelines and regulatory obligations
• Collaborating with cross-functional teams to produce high-quality documents
• Mentoring junior team members
• Staying informed about global regulatory requirements and drug safety profiles
• Project Management – leading and influencing teams, developing and adhering to project timelines and regulatory obligations, strong communication, negotiation and conflict management skills
• Collaboration with cross-functional teams to produce high-quality deliverables
• Mentoring junior team members

Q: What career progression is typical for a Medical Writer?

A: A typical career progression for a Medical Writer at Parexel may include:

• Associate Medical Writer: Entry-level position focusing on basic writing tasks and learning clinical development and regulations
• Medical Writer 1 and 2: Increased responsibilities in non-complex document preparation and project management
• Senior Medical Writer: Leading  and authoring complex deliverables and mentoring junior staff
• Principal Medical Writer: Leading and authoring complex, advanced projects, overseeing multiple  writers, advising client teams, acting as Subject Matter Expert in defined areas
• Senior Principal Medical Writer: Leading and authoring documents as well as client partnership oversight, training staff and contributing to strategic decisions and departmental initiatives
• Medical Writing Manager: Line management and client governance
• Director of Medical Writing: Shaping department strategy and vision; collaborations with related functional areas, and contributing to business development

Parexel Medical Writing offers various professional development and growth opportunities through:

• Apprenticeship and Mentorship programs
• Job shadowing
• Job rotations
• Stretch assignments
• Personalized development plans

Q: Which roles do I collaborate with as a Medical Writer?

A: As a Medical Writer at Parexel, you will collaborate with various roles across the organization and with clients, including:

• Other Medical Writers and support functions (Quality Control and Document Specialists)
• Biostatisticians
• Data Managers
• Regulatory Affairs Specialists
• Pharmacovigilance Experts
• Project Managers
• Quality Assurance Professionals
• Clinical Trial Managers
• Medical Directors

This cross-functional collaboration ensures comprehensive and accurate documentation throughout the clinical research process.

Q: How does a Medical Writer in clinical research differ from other industries?

A: Medical Writers in clinical research, particularly at Parexel, differ from those in other industries in several key ways:

• Regulatory focus: They must adhere to strict guidelines set by global and country-specific regulatory bodies like the FDA and EMA.
• Patient impact: Their work directly contributes to the development and safety of medical treatments.
• Scientific complexity: They deal with intricate scientific data from clinical trials and drug development.
• Specialized document types: They produce unique documents like study protocols, CSRs, PSURs, and RMPs.
• Pharmacovigilance knowledge: They need to understand drug safety profiles and signal detection.
• Global perspective: They often work on international projects requiring knowledge of various regulatory environments.
• Ethical considerations: They must maintain high ethical standards due to the sensitive nature of clinical data.
• Cross-functional collaboration: They work closely with diverse teams of scientists, clinicians, and regulatory experts.

Q: Will I have to travel as a Medical Writer?

A: Travel requirements for Medical Writers at Parexel are generally minimal. Most of the work can be done remotely or from a local office. However, some travel may occasionally be necessary for:

• Attending key client meetings
• Participating in important internal team discussions
• Presenting Parexel at industry conferences or events
• Attending training sessions or workshops

The extent of travel can vary depending on the specific role and project requirements, . Parexel strives to maintain a good work-life balance and leverages technology to minimize unnecessary travel.

Q: Are there remote job opportunities as a Medical Writer?

A: Yes, Parexel offers remote job opportunities for Medical Writers. The company recognizes the importance of work-life balance and flexibility, which is why they provide remote work options. As a Medical Writer, you can:

• Work remotely within defined core business hours
• Collaborate with virtual teams using advanced communication tools
• Participate in global projects from your home office
• Benefit from Parexel's supportive remote work culture

While some occasional in-person meetings may be required, Parexel strives to accommodate remote work arrangements, allowing Medical Writers to maintain a healthy work-life balance while contributing to critical clinical research documentation.