Location
- United Kingdom
- Romania
Category
The role
You'll lead the development of high-quality regulatory and clinical documents, guiding medical writing strategy, timelines, and resource requirements for key submissions. Working with cross-functional teams and clients, you'll ensure compliance with international regulations and serve as a key medical point of contact for clinical regulatory strategy. This full-time remote role is open at Medical Writer II, Senior, or Principal level, and requires the legal right to work in your country of residence.
At a glance
- Education
- Bachelor's Degree
- Experience
- 3+ years
- Level
- Mid-level
- Work authorization
- Required
Tools and skills
Skills
InclusionProtocol DevelopmentProblem SolvingRegulatory WritingSubstantive EditingContent CreationStatistical Analysis PlansMedical WritingDecision makingAgilityRegulatory SubmissionsInvestigator BrochuresResource PlanningInterpersonal SkillsICH GuidelinesIND SubmissionsClinical Study ReportsIntegrityeCTD SubmissionsStudy DesignOrganizationInitiativeTimeline ManagementLeadershipCommunicationCollaborationAttention to DetailRegulatory StrategyTherapeutic Area ExpertiseClinical Development

