1 day ago

Senior Medical Writer - FSP

IQVIA

Amsterdam

1 day ago

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IQVIA seeks an experienced Senior Medical Writer to lead development of clinical and regulatory documents for global submissions. The role involves strategic guidance, project management, and mentoring within a remote FSP arrangement.

RemoteFull-timeSeniorMedical WritingRegulatory Writing

Senior Medical Writer - FSP

Apply

RemoteFull-timeSeniorMedical Writing

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

5 years

Employment Type

Full-time

Experience Level

Senior

Core Qualifications

Technical (Must-have)

Medical WritingRegulatory WritingInvestigator's BrochuresClinical Study ReportsMarketing Authorization ApplicationsICH GuidelinesFDA RegulationsEMA RegulationsClinical ResearchStudy DesignData AnalysisRegulatory SubmissionsMicrosoft WordDocument FormattingeDMS

Soft Skills

Written CommunicationVerbal CommunicationOrganizational SkillsTime ManagementProject ManagementCollaborationIndependenceAttention to DetailMentoringStrategic Guidance

Key Responsibilities

•Lead development of high-quality clinical and regulatory documents (IBs, CSRs, clinical summaries, MAAs/NDAs/BLAs) in compliance with global regulatory guidelines and internal standards.
•Serve as lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs.
•Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning.
•Manage medical writing projects including planning, timelines, resource coordination, and delivery.
•Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety) to gather and present clinical data.
•Mentor and support other medical writers to ensure high-quality deliverables.
•Review and edit project-related documents for accuracy, clarity, consistency, and compliance.
•Attend project and team meetings to provide expert input on document development and process improvements.
•Contribute to and lead process improvement initiatives to enhance efficiency and quality.
•Develop, maintain, and refine SOPs, templates, and best practices for medical writing.
•Stay current with evolving global regulatory requirements and industry trends.

Senior Medical WriterFSPRegulatory WritingClinical DocumentsIQVIARemoteFull-timePharmaceuticalBiotechnologyCRO

Core Qualifications

Technical (Must-have)

Soft Skills

Written CommunicationVerbal CommunicationOrganizational SkillsTime ManagementProject ManagementCollaborationIndependenceAttention to DetailMentoringStrategic Guidance

Key Responsibilities

•Lead development of high-quality clinical and regulatory documents (IBs, CSRs, clinical summaries, MAAs/NDAs/BLAs) in compliance with global regulatory guidelines and internal standards.

•Serve as lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs.

•Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning.

•Manage medical writing projects including planning, timelines, resource coordination, and delivery.

•Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety) to gather and present clinical data.

•Mentor and support other medical writers to ensure high-quality deliverables.

•Review and edit project-related documents for accuracy, clarity, consistency, and compliance.

•Attend project and team meetings to provide expert input on document development and process improvements.

•Contribute to and lead process improvement initiatives to enhance efficiency and quality.

•Develop, maintain, and refine SOPs, templates, and best practices for medical writing.

•Stay current with evolving global regulatory requirements and industry trends.