Principal Regulatory Medical Writer - REMOTE at Jobgether

, , Canada -

Full Time

Start Date

Immediate

Expiry Date

24 May, 26

Salary

0.0

Posted On

23 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Medical Writing, Clinical Regulatory Documents, CTD Modules, Clinical Study Protocols, Clinical Study Reports, Submission Strategy, Data Presentation, Regulatory Positioning, Project Management, Stakeholder Coordination, eCTD Submission, Cross-functional Guidance, Global Regulatory Expectations, Clinical Development

Industry

Internet Marketplace Platforms

Description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Medical Writer. In this critical role, you will lead the authoring and development of complex clinical regulatory documents while working closely with a top-tier global pharmaceutical client. Your expertise will guide cross-functional teams and ensure successful submissions that align with regulatory expectations, making a real impact on the patients' lives by bringing life-changing treatments to the market faster. The position demands strong collaboration skills and a solid background in regulatory medical writing to navigate the complexities of drug development. Your contributions will be essential in crafting key documents and supporting the client’s strategic initiatives. \n Accountabilities Serve as a subject-matter expert on global clinical and regulatory writing projects Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports 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, drive consensus, 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 medical writing project lead Extensive experience leading development of clinical summaries and regulatory submission documents across regions Proven ability to guide cross-functional stakeholders through complex submission development Deep understanding of global regulatory expectations and clinical development Benefits Opportunity to shape your career Passionate work that remains hands-on with science and involves high-profile clients Support for deep technical expertise and training for leadership development Flexible work environment with the possibility of occasional travel Evolving responsibilities based on individual aspirations and strengths \n 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. #LI-CL1

Responsibilities

The Principal Regulatory Medical Writer will lead the authoring and development of complex clinical regulatory documents, serving as a subject-matter expert on global writing projects. Key duties include driving the development of essential documents like CTD Modules, Protocols, and Reports, and providing strategic input for submissions.