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| | Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medicines to improve the lives of patients. As a company, Biogen Idec recognizes that cutting-edge science and medicines can address unmet patient needs to change the course of devastating diseases.
Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. We have one of the strongest late-stage pipelines in the industry. In the coming years, we’re working hard to bring new therapies to market for patients with MS, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease), hemophilia, and others.
With more than 5,000 employees, Biogen Idec is a truly global organization – generating revenue of more than $5 billion worldwide in 2011. In addition to our headquarters in Weston, MA, and our research operations in Cambridge, MA, we have world-class manufacturing facilities in North Carolina and Hillerod, Denmark and offices in Canada, Australia, Japan and throughout Europe. We also have a direct commercial presence in 29 markets, including the US, EU, Brazil, China and India, and a network of distribution partners in more than 70 additional countries. | | Associate General Counsel, R&D, Legal | | Position: Associate General Counsel, R&D, Legal (Director Level)
Summary: The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This Attorney will work with other Attorneys in Biogen Idec’s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of Biogen Idec’s late stage development programs. Position reports directly to the VP, Chief R&D Counsel.
Specific responsibilities may include:
• Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents
• Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges.
• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products.
• Advise Drug Safety on recent developments in risk management
• Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims.
• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments. | | US-MA-Weston | | Legal & Compliance | | 15314BR | | Qualifications:
• 10+ years experience with global regulatory requirements in the bio/pharma industry required.
• Experience with regulatory submissions, requirements and drug safety management is required.
• Experience with government affairs, FDA and EMA regulations are required.
• Must have excellent interpersonal, decision making and communication skills. | | JD |
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