ClinDatrix is looking to hire a part time in-house Medical Writer. The ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities
- Write the following:
- Clinical Study Reports (CSRs) at the conclusion of clinical studies.
- Protocols and protocol synopses
- Annual Safety reports
- Annual Reports
- Periodic Safety Update Reports
- Publications Regulatory Writing
- Interact closely with clients to meet their medical writing objectives and timelines. Function will include planning of medical writing strategies in close association with client project goals.
- Prepare, assemble, and publish all CSRs in paper and electronic format.
Participate in global product team meetings to provide medical writing support and guidance. - Continuing education: remain current with regulations and guidance documents by attending meetings, seminars, and conferences on relevant topics, and by reading the scientific literature.
- Work within a team setting to meet timelines and objectives.
Qualifications and Requirements
- Masters or PhD degree or the equivalent in a biological scientific discipline
- Minimum of 7 years in the pharmaceutical industry, and 3-5 years of medical writing experience.
- A practical understanding of FDA and EMA regulations.
- Practical understanding of QA principles and practices.
- Able to perform independently.
- Demonstrate strong organization, communication and project management skills
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