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| Company |  | | | Services | | | | Logistics | | | | | |
| Cardiovascular (IC, EP, CHF) | | | | | | | | Physician Training and Consulting | | |
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| To independently facilitate and oversee the coordination, assembly, writing, editing and quality control of study/data reports, and/or protocols, which accurately reflect the study data and fulfill all protocol and GLP requirements. Additionally, involved in the development of report and data structure and presentation formats with preparation of text tables and/or associated graphs for reports and/or presentations. Provide guidance to others regarding specific study particulars and assistance/mentoring to junior medical writers. |
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Expectations include but are not limited to:
- Coordinate with and assist Study Director in the presentation of data and writing of report
- Organize the overall layout of study from constituent parts (sub-reports, etc)
- Assure the completeness of collection, assembly and organization of raw data
- Ability to work within established timelines
- Ability to assess and write Materials and Methods sections
- Manage the organization of report sections including formats, presentation of data (i.e., tables, graphs, etc)
- Ability to perform quality control on draft editions of reports, other documents/data and sub reports
- Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery, organization and generation of the report
- Proven ability to assist in the production and/or write scientific publications
- Perform all other related duties as necessary/assigned
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- Bachelor's or Master's degree in biological sciences, technical writing or equivalent field (with significant course work in biological sciences)
- Exceptional experience in a related field could substitute for the education requirement.
- Minimum four years experience in a regulatory pre-clinical or clinical testing environment with involvement in medical writer related activities
- Exceptional experience in related preclinical/clinical areas could substitute (e.g., study coordination or data coordination)
- Knowledge of domestic and foreign GLP regulations as they relate to reporting requirements and to study conduct
- Proficiency with Windows-based word processing, spreadsheets and presentation software
- Ability to multi-task with good communication, interpersonal, and organizational skills
- This position may require occasional domestic travel or performing duties on weekends and/or holidays.
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CBSET offers competitive salaries and fortune 500 benefits including; Medical, dental, vision, disability, and life insurance as well as paid time off and tuition reimbursement.
Send resumes to:
Contact: Kim Piccolo
Fax: 781-273-6644
Posted: 5/5/2009
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