Senior Medical Writer - FSP

IQVIA

FTE Medical Writer delivering clinical document writing services in biopharmaceutical industry. Collaborating with teams to ensure alignment and compliance with regulatory requirements.

Posted 7/30/2026full-timeReading • 🇬🇧 United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing for clinical documents, with strong knowledge of global regulatory requirements and clinical research processes. Proven ability to manage timelines, collaborate with cross-functional teams, and ensure quality and accuracy in document preparation.

Highest-signal resume keywords

Medical WritingRegulatory RequirementsProject ManagementClinical Research ProcessesElectronic Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingRegulatory SubmissionStatistical Analysis Plan ReviewQuality Control ChecksDocument ManagementData AnalysisStudy DesignDocument FormattingDraft PreparationConsensus Building

Soft Skills

Excellent Communication SkillsOrganizational SkillsTime ManagementAttention to DetailCollaborative Teamwork

Tools & Technologies

Microsoft WordElectronic Document Management SystemsStructured Authoring Tools

Industry Keywords

BiopharmaceuticalBiotechnologyCROICH GuidelinesFDA RegulationsEMA Guidelines

About the role

Key responsibilities & impact

Serve as an integrated member of the team, delivering medical writing services for the development of clinical documents
Participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions
Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
Review and approval of the Statistical Analysis Plan in the EDMS
Management of timelines including proposal of timelines to trial/project team
Preparation for and attendance of the required trial team meetings or submission meetings
Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team
Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes
Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF)
Creation and provision of the final document version to the trial/project team
E-approval of final clinical document in the EDMS

Requirements

What you’ll need

Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
High attention to detail with a commitment to quality, consistency, and scientific accuracy
Proficiency in Microsoft Word and document formatting best practices
Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools.

Benefits

Comp & perks

Professional development opportunities
Remote work options