Descripción de la oferta
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
