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Senior Medical Writer – FSP
ParexelSenior Medical Writer developing clinical and regulatory documents for Parexel, a global clinical research organization. Coordinating reviews, quality control, approvals, and publishing across clinical development teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and managing clinical and regulatory documents, including Clinical Trial Reports and Investigator's Brochures, while ensuring compliance with quality control and document management processes. Strong collaboration and communication skills are essential for effective project coordination within cross-functional teams.
Highest-signal resume keywords
Clinical Document ManagementMedical WritingElectronic Document Management SystemsProject CoordinationQuality Control Procedures
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ReportsClinical Trial ProtocolsDocument Lifecycle ManagementBiomarker ReportsRegulatory SubmissionsDocument Review ProcessesFormatting ChecksIn-Text Tables and FiguresQuality-Focused MindsetAttention to Detail
Soft Skills
CollaborationClear CommunicationOrganizationStakeholder ManagementProblem-Solving
Industry Keywords
Clinical ResearchRegulated EnvironmentCross-Functional TeamsProject GovernanceSubmission Meetings
About the role
Key responsibilities & impact- Develop and maintain clinical and regulatory documents including Clinical Trial Reports, Clinical Trial Protocols, protocol amendments, Investigator's Brochures, biomarker reports, and submission documents
- Manage clinical documents within the Electronic Document Management System, including document setup, workflow management, and approvals
- Establish, communicate, and maintain project timelines with trial and project teams
- Prepare, facilitate, and document project, kick-off, Results Alignment, trial team, and submission meetings
- Draft clinical documents with appropriate in-text tables and figures
- Coordinate document review cycles, drive alignment on comments, integrate revisions, and complete review documentation
- Initiate, conduct, or oversee quality control activities and complete supporting documentation
- Finalize and deliver completed documents and support 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 procedures, systems, and standard operating procedures
- Collaborate within integrated cross-functional teams and participate in project governance, feedback, and alignment activities
Requirements
What you’ll need- 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 and document lifecycle management processes
- Strong medical writing, project coordination, and document management capabilities
- Experience working in clinical research or another regulated environment
- Ability to collaborate across teams and communicate clearly with varied stakeholders
- Quality-focused mindset and strong attention to detail
- Comfort with electronic document management systems, document review processes, and quality control procedures
- 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- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Parexel Website LinkedIn All Job Openings 10,000+ employees Founded 1983 💼 Consulting 🏥 Healthcare 📦 Logistics 💰 Venture Round on 1990-01 Consulting
- Healthcare
- Logistics Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials. Senior Medical Writer – FSP 🔥 0 minutes ago 🌐 Poland, Romania, +2 more countries – Remote ⏰ Full Time 🟠 Senior 🏥📝 Medical Writer Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Develop and maintain clinical and regulatory documents including Clinical Trial Reports, Clinical Trial Protocols, protocol amendments, Investigator's Brochures, biomarker reports, and submission documents
- Manage clinical documents within the Electronic Document Management System, including document setup, workflow management, and approvals
- Establish, communicate, and maintain project timelines with trial and project teams
- Prepare, facilitate, and document project, kick-off, Results Alignment, trial team, and submission meetings
- Draft clinical documents with appropriate in-text tables and figures
- Coordinate document review cycles, drive alignment on comments, integrate revisions, and complete review documentation
- Initiate, conduct, or oversee quality control activities and complete supporting documentation
- Finalize and deliver completed documents and support 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 procedures, systems, and standard operating procedures
- Collaborate within integrated cross-functional teams and participate in project governance, feedback, and alignment activities 🎯 Requirements
- 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 and document lifecycle management processes
- Strong medical writing, project coordination, and document management capabilities
- Experience working in clinical research or another regulated environment
- Ability to collaborate across teams and communicate clearly with varied stakeholders
- Quality-focused mindset and strong attention to detail
- Comfort with electronic document management systems, document review processes, and quality control procedures
- 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 Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs