Vacancy has expired
Show me jobs like this one| Job Ref: | MedWrtr |
| Sector: | Pharmaceutical and Medical Device |
| Job Type: | Full Time |
| State: | California (CA) |
| City: | Berkeley |
| Post Code: | Mar 12, 2012 |
| Job Description: |
PRIMARY PURPOSE OF POSITION: Manage the medical and other technical writing needs for Clinical Development. Partner with the appropriate medical monitors and other clinical staff to determine project needs to effectively write, edit, and/or review and QC clinical documents including, but not limited to, clinical study reports, investigator brochures, protocols, integrated regulatory summary documents, standard operating procedures (SOPs), and guideline documents. This position will create documents that effectively and clearly convey clinical and scientific data, ensuring that such documents comply with regulatory guidelines in terms of content, structure, and style. Evaluate workflow and delivery targets to determine resource needs. Retain appropriate resources and oversee contract medical writers as needed to support program initiatives and meet project deadlines in a timely manner. This position is equivalent to a manager level and receives assignments in the form of objectives and establishes goals to meet objectives. Incumbent provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect subordinate organizations. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules. MAJOR DUTIES OF POSITION: Create and update high-quality clinical documents that support clinical program goals and objectives that may include such documents as investigator brochures, protocols, clinical study reports, and safety narratives. Evaluate and determine workload and retain appropriate contract support to ensure project deadlines are not negatively impacted. Oversee the work of contract staff to ensure alignment with project deliverables. Evaluate draft documents and prepare summary of statistical output for accuracy and consistency. Responsible for researching, writing, editing, and QC of clinical reports Summarize data from clinical studies for submission to the FDA or other Regulatory Authorities and for publication and/or presentation. Develop and update SOPs in accordance to technical and industry standards. Develop and update formats and guidelines for clinical documentation. Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork. Other duties as assigned. Requirements KNOWLEDGE AND SKILL REQUIREMENTS: |
| Post Date: | 03/13/2012 |
