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Acceleron Pharma Work Values
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Daily Duties at Acceleron Pharma:
Oversaw and managed the direction of regulatory affairs and quality assurance operations for a start-up biotechnology company. Developed and implemented the regulatory strategies for the development of biological therapies in the areas of osteoporosis, adjunctive oncology, and muscle atrophy associated with muscular dystrophy, ALS, and cancer cachexia. Conducted multiple face-to-face meetings with the FDA, defending Phase II/III development programs and negotiating regulatory filing requirements for pre-clinical toxicology and manufacturing. Developed content for pre-IND meetings and IND submissions. Interpreted regulations, guidance documents and directives for internal impact assessment and advised on potential areas of regulatory concern and new regulatory developments. Managed quality assurance operations to ensure the establishment and implementation of effective and efficient quality systems and procedures designed to support the manufacture of complex biological therapeutic candidates, ensuring compliance with internal and external requirements and quality system regulations. Supported development of standard operating procedures, and monitored quality problems with products, processes, and/or quality management systems. Managed quality assurance team consisting of four QA specialists. Served as regulatory affairs representative on cross-functional due diligence teams resulting in 3 development partnerships.
What they like about Acceleron Pharma:
Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.
Skills
Information about Acceleron Pharma
Company Rank: Not Available
Average length of employment : 1 year
Average salary of employees: $127,500
These are some of the questions we asked our climbers about their experiences with Acceleron Pharma:
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I would recommend this as a place of employment. | 0.0 | |
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I feel employees are fairly compensated. | 0.0 |
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