Role Overview
As a Senior Medical Writer, you will take a lead role in preparing complex study- and project-level documents, including protocols, Investigator Brochures (IBs), clinical evaluation reports, informed consent forms, and submissions for regulatory authorities globally. You will work closely with cross-functional teams, providing expertise and guidance to ensure high-quality and timely deliverables .
Key Responsibilities
* Independently author complex clinical documents (protocols, IBs, clinical summaries, CTD/eCTD submissions, PIPs, CERs, and regulatory responses)
* Prepare briefing books, slides, and meeting packages for advisory committees and other stakeholder meetings
* Lead and coordinate medical writing tasks, ensuring adherence to timelines and high-quality outputs
* Provide guidance and mentorship to junior writers
* Act as the primary contact for stakeholders regarding assigned deliverables
* Participate in project meetings and contribute to medical writing strategy and decision-making
Requirements
* Minimum 5 years of medical writing experience, including at least 2 years as a project lead
* Experience with regulatory submissions and study-level documents
* Strong project management, communication, and stakeholder engagement skills
* Ability to work independently and proactively
* Experience with medical devices is a plus but not required
Ideal Candidate
* Highly proactive, organized, and collaborative
* Strong understanding of submission processes and regulatory requirements
* Demonstrates ownership and can drive tasks from draft to finalization
* Comfortable working remotely and integrating with cross-functional teams