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Show me jobs like this one| Job Ref: | 66 |
| Sector: | Pharmaceutical and Medical Device |
| Job Type: | Full Time |
| State: | Massachussetts (MA) |
| City: | Cambridge |
| Post Code: | Jan 31, 2012 |
| Job Description: |
ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise. Job Description Summary The Medical Writing Department reports to the Chief Medical Officer (CMO) of Clinical Research and Development. This position will report to the Head of Medical Writing. The Medical Writer, Manager will primarily be required to independently plan, write, and review clinical and regulatory documents, along with conference materials and publications, for ARIADs proprietary compounds. Prior Medical Writing experience is essential; oncology writing experience is preferred. Duties and Responsibilities Responsibilities will involve planning, preparation, writing, reviewing, editing, formatting, and finalizing clinical and regulatory documents, along with conference materials and publications for ARIADs proprietary compounds. Documents will include, but are not limited to, clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, other regulatory submission documents, abstracts, manuscripts, reviews, posters, and slide decks for internal and external use. In addition, the individual will perform quality control review and peer review of clinical, regulatory and publication documents. In order to deliver final documents, the individual will collaborate with Clinical Research and Development colleagues, along with other ARIAD departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, biology, medical affairs, and the commercial group. The individual will represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams. The Medical Writer, Manager will also lead and be involved with process development and process improvement initiatives both within the Medical Writing Department and throughout the organization. To ensure compliance, the individual will remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature. If required, the individual may oversee other Medical Writers. Requirements - A minimum of BA or BS degree. Advanced scientific degree in the life sciences preferred (MS or PhD). |
| Post Date: | 02/01/2012 |
