Medical Writer II – FSP

Parexel

Medical Writer II preparing clinical and regulatory documents for Parexel, a global clinical research organization. Coordinating reviews, quality control, timelines, approvals, and publishing across clinical development programs.

Posted 8/5/2026full-timeRemote • 🇵🇱 PolandJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and maintaining clinical and regulatory documents, managing document workflows, and ensuring compliance with established procedures. Proficient in collaborating within cross-functional teams to support clinical trial documentation and regulatory submissions.

Highest-signal resume keywords

Medical Writing ExperienceClinical Development DocumentationElectronic Document Management Systems (EDMS)Quality Control ActivitiesStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document DevelopmentRegulatory SubmissionsDocument Lifecycle ManagementTechnical Document FormattingIn-Text Tables and Figures Drafting

Soft Skills

Strong CommunicationOrganization SkillsProblem-Solving Skills

Industry Keywords

Clinical TrialsRegulated Working EnvironmentsDocument Review WorkflowsProject GovernanceIntegrated Team Environment

About the role

Key responsibilities & impact

Develop and maintain clinical and regulatory documents including CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission documents
Manage clinical documents within the Electronic Document Management System (EDMS), including document setup, workflow management, and approvals
Establish, communicate, and maintain agreed project timelines in collaboration with trial and project teams
Prepare for, facilitate, and document project meetings, kick off meetings, Results Alignment Meetings, trial team meetings, and submission meetings
Draft clinical documents, including in-text tables and figures, in accordance with agreed timelines and applicable procedures
Coordinate and manage document review cycles, drive alignment on comments, integrate revisions, and complete required review documentation
Initiate, conduct, or oversee quality control activities and complete supporting quality control documentation
Finalize and deliver completed documents to project teams and support document publishing and pre-archive activities
Perform technical and formatting checks for Investigator's Brochures and related updates
Support final electronic approval processes and ensure compliance with established procedures, systems, and standard operating procedures
Collaborate within an integrated team environment and participate in project governance, feedback, and alignment activities

Requirements

What you’ll need

At least 1 year of experience as a Medical Writer
Bachelor's degree or equivalent combination of education and relevant experience
Knowledge of clinical development documentation processes and regulated working environments
Experience working with Electronic Document Management Systems (EDMS) and document lifecycle management processes
Strong communication, organization, stakeholder management, and problem-solving skills
Advanced scientific, life sciences, or related educational background preferred
Experience supporting clinical trial documentation and regulatory submissions preferred
Familiarity with clinical document review, quality control, publishing, and approval workflows preferred
Experience collaborating within cross-functional clinical development teams preferred

Benefits

Comp & perks

Opportunity to deepen knowledge of clinical development processes
Integrated team environment
Ongoing project governance, feedback, and alignment activities