- Bristol-Myers Squibb Company
- $104,720.00 -147,530.00/year*
18 Brentwood Ct
To coordinate the preparation of safety narratives required for inclusion in clinical study reports by contributing to their planning, writing, reviewing and presentation.Key Responsibilities and Major Duties
Contribute to and maintain the plans for preparation of safety narratives for individual studies in collaboration with the medical and writing teams
Oversee and manage the narrative preparation process from initial drafts through finalization and incorporation into the clinical study report
Review and QC the scientific content of safety narratives for compliance with ICH guidelines and regulatory requirements
Edit safety narratives so that they adhere to good writing practices
Properly format and finalize narrative appendices for incorporation into the clinical study reportMinimum Requirements
Graduate (BS) level degree plus sufficient experience or post-graduate level degree in a patient-based, health-related discipline, such as nursing, pharmacy, psychology
Experience - Responsibility and minimum number of years
Bachelor-level degree, with at least 8 years of practical experience, including at least 3 years of direct clinical experience, i.e., patient contact, or graduate-level degree, with at least 3 years of direct clinical experience, i.e., patient contact
Three or more years of pharma industry experience such as in medical writing, pharmacovigilance, clinical research/operations, or regulatory affairs
Drug safety knowledge and experience, a plus
Competencies - knowledge, skills, abilities, other
Oral and written Fluency in English
Able to work in a matrixed environment
Familiarity working in regulated environments
Ability to work efficiently under strict timelines
Ability to recognize inconsistency or gaps in medical summaries, and query and/or rewrite appropriately.
Associated topics: climate, constable, emr, hazard, health, risk, scba, waste, wastewater, wastewater treatment plant
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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