Job summary
An opportunity for an experienced Senior Medical Writer to lead the creation of clinical and regulatory documents supporting global submissions. The role focuses on producing high-quality, scientifically accurate materials such as Investigator's Brochures and Clinical Study Reports in compliance with international regulatory standards. The position requires leadership in managing writing activities across multiple projects and providing strategic input to interdisciplinary teams.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead the preparation of essential clinical and regulatory documents ensuring scientific accuracy and regulatory compliance; oversee multiple writing projects simultaneously. Provide strategic guidance on content and messaging to align with program goals. Manage timelines and coordinate resources to meet submission deadlines. Collaborate with various departments to gather and interpret clinical data. Mentor junior writers and review documents for quality and consistency. Participate in process improvements and maintain writing standards and templates. Stay updated on regulatory changes and industry trends.
Qualifications
Bachelor's degree in a scientific or regulatory field is required; advanced degrees are preferred. At least five years of medical writing experience in biopharmaceuticals, biotechnology, or CRO settings, or equivalent clinical development experience. Strong knowledge of global regulatory requirements and clinical research processes. Proven leadership in document development and team collaboration. Excellent written and verbal communication skills. Strong organizational and project management abilities. Experience with Microsoft Word, electronic document management systems, and document templates. High attention to detail and commitment to quality.