Location
US-MA-Cambridge
Job Category
Drug Safety
Requisition Number
20875BR
Qualifications
Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology.
Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues for partnered
Develops and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Excellent written and verbal communication skills. Demonstrated presentation skills.
Extensive medical writing, editing, and source document review.
Clinical judgment, ability to interpret case information
Knowledge of drug development process.
Basic knowledge of applicable clinical trial safety regulations and postmarketing regulations.
Demonstrated ability to independently manage complex projects with multidisciplinary teams
Medical writing, editing, and source document review.
Clinical judgment, ability to interpret case information
Basic medical literature search skills.
Strong organizational skills, including the ability to prioritize independently with minimal supervision.
Ability to adapt to a rapidly changing environment
Proven ability to evaluate. clinical and epidemiologic data
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Knowledge of common safety database systems
Minimum 3 years relevant experience (including industry experience) with familiarity with industry principles of drug safety, drug development, regulatory, pharmacology, and pharmacoepidemiology.
Education
Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc).
Biogen Idec - 4 days ago - save job - block
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