The Medical Writer is responsible for preparing clinical research documents including but not limited to protocols, Investigator’s Brochures and clinical study reports. The incumbent possesses knowledge of current industry practices and regulatory requirements that affect medical writing and is able to fulfill responsibilities with some direct supervision. This position will manage a number of tasks and projects simultaneously. The Medical Writer will take ownership of performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all study-specific synopses and protocols. The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Solution-Oriented and 4) Do the impossible.
- Collaborate with corporate and clinical team to understand scope of projects, assess data, and author relevant documents.
- Write, review, and edit deliverables covering all phases of clinical research including comprehensive clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
- Ensure all deliverables are compliant with FDA regulations, standards, and ICH guidelines.
- Stay up to date with current industry practices and regulatory requirements that affect medical writing.
- Prepare abstracts, scientific exhibits, posters and oral presentations.
- Plan, coordinate, and prepare for meetings and teleconferences with appropriate stakeholders.
- Work with peers to develop standard operating procedures and departmental guidelines.
- Participate as a full member of the research and development team(s) for the company’s products.
- Develop and manage project specific timelines, in keeping with corporate objectives and actively participate on project teams advising on preparation timelines, processes, and requirements.
- Multi-task efficiently with minimal supervision and be able to pivot between projects as required.
- Mentor writing associates and junior colleagues.
- Maintain confidentiality.
- Perform other tasks assigned by the company’s management.
- A minimum of a MS degree in biomedical sciences or related discipline with 3 years of experience.
- PhD or MD preferred.
- Familiarity with principles of clinical research.
- Ability to interpret and present clinical data.
- Proficiency in MS Office Suite.
- Excellent verbal and written communication skills.
- Performs consistently beyond expectations.
- Maintains a high degree of accuracy and attention to detail while performing the company’s work.