Senior Regulatory Medical Writer - CRO
- Experience Level
- Experienced (non-manager)
We're a global, world-leading clinical research organisation (CRO) that look to advance clinical research providing outsources services to pharmaceutical, biotechnology, medical device, and government and public health organisations.
We are a team of experts, bright thinkers, dreamers changing the way the world experiences CROs, in the best way possible.
Summary: The Senior Medical Writer is responsible for carrying out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget, and to the written, scientific, and ethical standards in accordance with regulatory requirements.
- Prepare study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other documents in accordance with regulatory requirements.
- Prepare product documents such as investigator drug brochures, summary documents, and others in accordance with regulatory requirements.
- Coordinate internal and client document review cycles.
- Attend project-related meetings, as needed.
- Perform review and QC of documents, as needed.
- Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as needed.
- Create and manage project-specific timelines, an adaptation of timing, and milestones based on client needs/feedback.
- Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
- Advise project team and clients on medical writing-related issues.
- Complete project-specific and company training, as assigned.
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 3 years of experience in a lead medical writing role in the pharmaceutical/CRO industry.
- Excellent writing skills.
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
- Knowledge of current requirements and guidelines applicable to submission documents
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects