At Biogen, our mission is clear: we are pioneers in neuroscience.
Since our founding in 1978 as one of the world’s first global biotechnology companies by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
The Senior Associate Scientist, Study Management position will report to the Study Management and Operations within Preclinical Safety. The position primarily involves coordinating late discovery and development programs while effectively setting and meeting study and program specific timelines and milestones. The person in this role will assume primary responsibility as liaison between Preclinical Safety and various contract sites and numerous internal contacts.
Direct responsibilities will include, but not be limited to:
- Responsible for coordinating and managing all aspects of studies conducted at Contract Research Organizations, including but not limited to: contracting, protocol development, study monitoring, data review, timelines, data review and reporting
- Responsible for communicating and coordinating with vendors, preclinical safety functions and across supporting functional areas
- Ensure controlled documents are current, study data is properly stored, budgets are projected for program support
- Support the preparation of Preclinical sections of regulatory submission documents as required
- Author/reviewer of preclinical safety-related standard operating procedures
- 8 + years of experience in the pharmaceutical industry with demonstrated ability to effectively run and manage preclinical safety studies
- Strong communication and organizational skills
- Thorough knowledge of GLP compliance and study management
- Critical thinking, negotiation and leadership skills a must
- Ability to productively collaborate across functions
- Project management skills a plus
BS or MS in scientific field (biology, biotechnology, toxicology, veterinary medicine)
All your information will be kept confidential according to EEO guidelines.