The Medical Writer will manage the writing of clinical reports, protocols, investigator brochures, package inserts, clinical plans to ensure that these documents have been written in compliance with general GCP, the protocol, appropriate Standard Operating Procedures (SOPs), applicable guidelines & regulations. Development of scientific posters, journal manuscripts etc. may also be required.
Other responsibilities will include, but are not limited to:
• Overall responsibility for the supervision of the development of these documents by coordinating the contributions of the different functions involved.
• Responsible for the maintenance and tracking of the versions of these documents during development and approval process.
• Ensuring that all sections of these documents are complete and comply with the applicable guidelines & regulations.
• Ensuring that the documents are reviewed and approved by designated personnel.
• Maintaining an electronic copy of each approved document.
Minimum qualifications include BA/BS in a scientific, medical or statistical discipline; 2-3 years experience writing scientific or medical articles; an understanding of medical terminology and statistical methods; strong computer skills including word processing and presentation software. Must be knowledgeable of regulatory report guidelines and Good Clinical Practices. Must be able to interpret statistical analysis of clinical trial data. Must be able to work independently and as a team member. Must be detailed oriented and have a professional demeanor and appearance.
Preferred Qualifications: MA/MS or PhD in a scientific, medical or statistical discipline; 3+ years experience in a CRO or pharmaceutical company environment.