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This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Medical Writer. In this role, you will lead the development of complex clinical regulatory documents for a key strategic client in the pharmaceutical industry. Your expertise will have a real impact on bringing life-changing treatments to patients faster, as you will serve as a core team member, driving projects that align with regulatory strategies and clinical objectives. This position offers the opportunity to engage deeply with high-profile clients while shaping your career in a collaborative environment.
Accountabilities
- Serve as a subject-matter expert on global clinical and regulatory writing projects
- Lead the writing, review, and coordination of complex documents, including CTD Modules and Clinical Study Protocols
- Drive development of key clinical documents that align with overall program and submission strategy
- Provide strategic input that shapes messaging, data presentation, and regulatory positioning
- Lead and manage complex medical writing projects across cross-functional teams
- Coordinate stakeholders, facilitate discussions, and support timely decision-making throughout the document lifecycle
Requirements
- Bachelor’s degree in life science
- Advanced degree (PhD or Master’s) in a life science discipline preferred
- Minimum 6 years of eCTD submission medical writing experience, including 3+ years as a project lead
- Extensive experience leading development of clinical summaries and regulatory submission documents
- Proven ability to guide cross-functional stakeholders through complex submission development
- Deep understanding of global regulatory expectations and clinical development
Benefits
- Opportunity for hands-on engagement with science and high-profile clients
- Support for deep technical expertise and training for leadership roles
- Flexible work environment accommodating remote work
- Engagement in meaningful work that impacts patient care
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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