Principal Regulatory Medical Writer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Principal Regulatory Medical Writer leading clinical regulatory document development for a top global pharmaceutical client. Committed to bringing life-changing treatments to patients faster.
Responsibilities:
- Lead the authoring and development of high‑complexity clinical regulatory documents
- Serve as a subject‑matter expert on global clinical and regulatory writing projects
- Lead the writing, review, and coordination of complex documents
- 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.
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
- 3+ years as a medical writing project lead
- Extensive experience leading development of clinical summaries (efficacy and/or safety) 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.
- Comfortable leading discussions, managing complex writing processes, influencing stakeholders, and contributing confidently based on experience.
Benefits:
- Professionally development opportunities
- Health insurance
Similar Jobs
Medical Writer
Medical Writer developing evidence-based scientific content for healthcare professionals. Collaborating with teams to ensure adherence to regulatory standards while focusing on impactful communication strategies.
Medical Writer
Medical Writer developing high-quality medical and scientific content aligned with regulatory standards. Collaborating with various teams to ensure adherence to guidelines and address healthcare communication needs.
Medical Writer
Medical Writer developing high-quality scientific content for healthcare communications. Collaborating with medical affairs and regulatory teams to ensure compliance and integrity in medical documentation.
Medical Writer
Medical Writer developing high-quality scientific content for healthcare professionals. Collaborating with cross-functional teams to ensure adherence to regulatory standards and scientific integrity.
Medical Writer
Medical Writer developing high-quality medical and scientific content aligned with regulatory and brand standards. Supporting Medical Affairs and cross-functional teams in effectively communicating clinical data.
Medical Writer
Medical Writer developing medical content aligned with clinical guidelines and regulatory standards. Collaborating with stakeholders on scientific communication and maintaining content accuracy under compliance.
Medical Writer
Medical Writer creating high-quality medical content based on clinical data for stakeholders. Collaborating with teams to ensure scientific integrity while working remotely from South Korea.
Medical Writer
Medical Writer developing compliant scientific content aligned with clinical data. Collaborating with stakeholders and ensuring adherence to medical standards in healthcare communications.
Medical Writer
Medical Writer responsible for writing clinical documents like CSRs and protocols at a leading biotechnology company. Collaborating with teams to ensure adherence to standards.
Clinical Documentation Integrity Specialist II
Clinical Documentation Integrity Specialist improving the accuracy of provider-based clinical documentation through assessment and collaboration. Engaging with healthcare providers for compliant documentation and supporting quality care outcomes.
Medical Writer, Patient Support
Medical Writer developing and writing content for pharmaceutical patient support programs. Collaborating with internal teams to ensure content accuracy and adherence to client vision.
Consulting Healthcare Manager – Clinical Documentation Improvement Delivery
Healthcare Consulting Manager managing complex projects in healthcare consulting. Leading teams to optimize business operations and improve clinical outcomes.
Healthcare Consulting Manager – Inpatient Clinical Documentation Improvement
Healthcare Consulting Manager overseeing clinical documentation improvement projects for healthcare organizations. Managing multi-workstream projects and developing junior team members in a rapidly changing environment.
Medical Writer, Publications
Medical Writer at RTI Health Solutions producing medical publications and collaborating on healthcare consulting projects. Leading publication initiatives and ensuring high-quality deliverables in a research-driven environment.
RN Clinical Documentation Specialist Lead
Clinical Documentation Specialist Lead managing documentation improvement processes at Ochsner Health. Facilitating clinical resources and improving departmental initiatives for documentation accuracy.
Senior Medical Writer
Lead medical writing projects for Clinical Research Scientists and Sponsors, managing complex tasks and ensuring compliance with industry standards. Coordinate reviews and support junior writers while developing timelines.
Medical Writer
Medical Writer leading content planning and production of regulatory documents for medical R&D. Collaborating with authors and technical specialists while managing timelines and quality control processes.
Senior Medical Writer
Lead Medical Writer at IQVIA developing and reviewing clinical documents. Collaborating with teams and providing mentorship while ensuring compliance with SOPs and customer requirements.
Senior Medical Writer
Senior Medical Writer providing regulatory writing support for argenx's clinical and safety documents. Collaborating with project teams to ensure compliance and accuracy in submissions.
Clinical Documentation Quality Analyst
Clinical Documentation Quality Analyst improving documentation integrity and medical coding at The Ohio State University Health System. Managing quality reviews and providing education to healthcare providers.