Medical Writer Jobs
Durham, NC
Job Summary
The medical writer in Regulatory Services is responsible for assisting the Senior medical writer in managing the effective and efficient utilization of personnel and resources related to the areas of U.S. and international pharmaceutical regulations and guidelines. The medical writer is expected to provide advice and direction to Sponsors and other Kendle functional units regarding general and specific regulatory requirements that impact the conduct of clinical studies including but not limited to protocol design, overall development strategies and data analysis issues. The medical writer is also responsible for generating and presenting training modules, NBD customer presentations, and preparing and presenting Kendle College courses on subjects related to U.S. and international drug development requirements. The medical writer may also be required to manage tasks in other functional areas based on experience and the unit's needs.
Core Responsibilities
The medical writer is responsible for assisting the Senior medical writer in managing the effective utilization of skills to review and interpret clinical and scientific data and to incorporate and describe the data and the conclusion drawn from it in the appropriate report forms subject to Sponsor requirements. This responsibility also includes the quality control of reports and data to ensure accuracy of the report and conformity to specific Sponsor style and formatting. In addition, it involves working with the Sponsor and other Kendle functional units to obtain, and ensure the quality of, the data being included in reports.
Principal Responsibilities:
Conduct quality control review of clinical study reports, tables and listings, investigational brochures, protocols and other regulatory documents related to regulatory submissions including INDs and NDAs. Provide direction to other Regulatory Specialists and support personnel who may be assisting.
Assist in coordinating efforts of other groups within Kendle in incorporating data and information into reports and ensuring its accuracy.
Assist and work with the Senior Regulatory Specialist in the development of various reports.
Responsible for writing specific areas of clinical study reports including methods, demographics, protocol deviations, concomitant medications, safety narratives, etc.
Assist the senior medical writer or medical writerwith the writing of efficacy or safety sections and building tables for clinical study reports and common technical documents.
Responsible for generation and assembly of appendices for major documents and incorporate as required by the Sponsor in collaboration with the lead writer (where applicable).
Works with regulatory documentation & submission specialist under supervision of the Kendle Regulatory Management to prepare initial INDs, amendments, reporting of SAEs, and revised investigator information.
Other duties and assignments as requested for the overall performance of the unit.
Skills & Attributes
The Candidate/incumbent should have a minimum of a bachelor degree with relevant pharmaceutical experience or a professional degree or advanced degree in the life sciences. Candidate/incumbent should have a complete an understanding and application of principles, concepts, practices and standards in the CRO industry. Candidate/incumbent should have the ability to learn and follow task specific procedures. Candidate/incumbent should be attentive to detail and accuracy of information, flexible, open to suggestions, and possess excellent written. Candidate/incumbent should be able to interact with staff from multiple functional units and Kendle offices to establish project standards. Candidate/incumbent should have some computer literacy word processing and spreadsheet applications. Candidate/incumbent should have strong management, organizational, communication, and interpersonal skills.
Tasks, duties and responsibilities as listed in this job description are not exhaustive. The company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
For more information please call 800-733-1572
